129 results on '"Veith, Miroslav'
Search Results
2. Faricimab Treat-and-Extend for Diabetic Macular Edema: Two-Year Results from the Randomized Phase 3 YOSEMITE and RHINE Trials
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Aaberg, Thomas, Jr., Abbey, Ashkan, Abdulaeva, Elmira, Abengoechea, Santiago, Abraham, Prema, Ach, Thomas, Adams, Serrhel, Adan Civera, Alfredo, Adrean, Sean, Agostini, Hansjurgen, Alam, Suhail, Alezzandrini, Arturo, Alfaro, Virgil, Aliseda, Daniel, Almony, Arghavan, Amat, Pedro, Amini, Payam, Antoszyk, Andrew, Arias, Luis, Asaria, Riaz, Avila, Marcos, Awh, Carl C., Bafalluy, Joaquin, Baker, Carl, Bandello, Francesco, Barakat, Mark, Barraza, Karen, Bator, Gyorgy, Baumal, Caroline, Belfort, Rubens, Jr., Bergstrom, Chris, Bertolucci, George, Bochow, Thomas, Bolz, Matthias, Borcz, Emilia, Bordon, Arnaldo, Boyer, David, Bratko, Galina, Brent, Michael, Brown, Jamin, Brown, David M., Budzinskaya, Maria, Buffet, Sylvia, Burgess, Stuart, Burton, Ben, Busquets, Miguel, Cabrera, Francisco, Cagini, Carlo, Calzada, Jorge, Campochiaro, Peter, Carlson, John, Castellarin, Alessandro, Cava, Carlos, Chaikitmongkol, Voraporn, Chan, Clement, Chang, Emmanuel, Chang, Jonathan, Chang, Andrew, Charles, Steve, Chaudhry, Nauman, Chee, Caroline, Chen, Judy, Chen, Fred, Chen, Shih-Jen, Cheong-Leen, Richard, Chiang, Allen, Chittum, Mark, Chow, David, Connolly, Brian, Cornut, Pierre Loic, Csaky, Karl, Danzig, Carl, Das, Arup, Daskalov, Vesselin, Desco, Carmen, Dessouki, Amr, Dickinson, John, Do, Brian, Dollin, Michael, Dugel, Pravin, Dusova, Jaroslava, Eichenbaum, David, Eldem, Bora, Engstrom, Robert, Ernest, Jan, Escobar, Joan Josep, Esposti, Simona, Eter, Nicole, Falk, Naomi, Farkas, Andrej, Feiner, Leonard, Feltgen, Nicolas, Fernandez, Carlos, Fernandez Vega, Alvaro, Ferrone, Philip, Figueira, Joao, Figueroa, Marta, Findl, Oliver, Fine, Howard, Fortun, Jorge, Fox, Gregory M., Foxman, Scott, Framme, Carsten, Fraser-Bell, Samantha, Fu, Arthur, Fukutomi, Akira, Fung, Nicholas, Furno Sola, Federico, Gallego-Pinazo, Roberto, Garcia, Renata, Garcia-Layana, Alfredo, Gawecki, Maciej, George, Sheen, Ghanchi, Faruque, Ghorayeb, Ghassan, Goldberg, Roger, Goldstein, Michaella, Gomes, Nuno, Ulla, Francisco Gomez, Gonzalez, Victor, Greven, Craig, Gupta, Sunil, Guzman, Miguel, Harris, Martin, Hatz, Katja, Hau, Vivienne, Hau, Vincent, Hayashi, Ken, Heier, Jeffrey, Herba, Ewa, Hershberger, Vrinda, Higgins, Patrick, Hirakata, Akito, Ho, Allen, Holekamp, Nancy, Honda, Shigeru, Hsu, Jason, Hu, Allen, Hurcikova, Maria, Ikeda, Yasuhiro, Isernhagen, Ricky, Ito, Yasuki, Jackson, Tim, Jacoby, Rachael, Jafree, Afsar, Javey, Golnaz, Javid, Cameron, Jhaveri, Chirag, Johnson, Mark, Kacerík, Marek, Kaluzny, Jakub, Kampik, Daniel, Kang, Se Woong, Kapoor, Kapil, Karabas, Levent, Kawasaki, Tsutomu, Kerenyi, Agnes, Khanani, Arshad, Khurana, Rahul, Kim, Brian, Kimura, Kazuhiro, Kishino, Genichiro, Kitano, Shigehiko, Klein-Mascia, Kendra, Kokame, Gregg, Korobelnik, Jean Francois, Kulikov, Alexey, Kuriyan, Ajay, Kwong, Henry, Kwun, Robert, Lai, Timothy, Lai, Chi-Chun, Laird, Philip, Lalonde, Laurent, Lanzetta, Paolo, Larsen, Michael, Laugesen, Caroline, Lavinsky, Daniel, Lebreton, Olivier, Lee, Seong, Levy, Jaime, Lipkova, Blandina, Liu, Mimi, Liu, Judy, Lohmann, Chris P., London, Nikolas, Lorenz, Katrin, Lotery, Andrew, Lozano Rechy, David, Lujan, Silvio, Ma, Patrick, Maeno, Takatoshi, Mahmood, Sajjad, Makkouk, Fuad, Malik, Khurram, Marcus, Dennis, Margherio, Alan, Mastropasqua, Leonardo, Maturi, Raj, McCabe, Frank, McKibbin, Martin, Mehta, Hemal, Menon, Geeta, Mentes, Jale, Michalska-Malecka, Katarzyna, Misheva, Aneta, Mitamura, Yoshinori, Mitchell, Paul, Modi, Yasha, Mohamed, Quresh, Montero, Javier, Moore, Jeffrey, Morales Canton, Virgilio, Morori-Katz, Haia, Morugova, Tatiana, Murakami, Tomoaki, Muzyka-Wozniak, Maria, Nardi, Marco, Nemcansky, Jan, Nester-Ostrowska, Kamila, Neto, Julio, Newell, Charles, Nicolo, Massimo, Nielsen, Jared, Noda, Kousuke, Obana, Akira, Ogata, Nahoko, Oh, Hideyasu, Oh, Kean, Ohr, Matthew, Oleksy, Piotr, Oliver, Scott, Olivier, Sebastien, Osher, James, Ozcalışkan, Sehnaz, Ozturk, Banu, Papp, Andras, Park, Kyu Hyung, Parke, D. Wilkin, Parravano, Maria Cristina, Patel, Sugat, Patel, Sunil, Pearce, Ian, Pearlman, Joel, Penha, Fernando, Perente, Irfan, Perkins, Stephen, Pertile, Grazia, Petkova, Iva, Peto, Tunde, Pieramici, Dante, Pollreisz, Andreas, Pongsachareonnont, Pear, Pozdeyeva, Nadezhda, Priglinger, Siegfried, Qureshi, Jawad, Raczynska, Dorota, Rajagopalan, Rajesh, Ramirez Estudillo, Juan, Raskauskas, Paul, Rathod, Rajiv, Razavi, Hessam, Regillo, Carl, Ricci, Federico, Rofagha, Soraya, Romanczak, Dominika, Romanowska-Dixon, Bożena, Rosberger, Daniel, Rosenblatt, Irit, Rosenblatt, Brett, Ross, Adam, Ruamviboonsuk, Paisan, Ruiz Moreno, Jose Maria, Salomão, Gustavo, Sandhu, Sukhpal, Sandner, Dirk, Sararols, Laura, Sawada, Osamu, Schadlu, Ramin, Schlottmann, Patricio, Schuart, Claudia, Seitz, Berthold, Seres, András, Sermet, Figen, Shah, Sandeep, Shah, Ankur, Shah, Rohan, Sharma, Sumit, Sheidow, Thomas, Sheth, Veeral, Shimouchi, Akito, Shimura, Masahiko, Sikorski, Bartosz, Silva, Rufino, Singer, Michael, Singerman, Lawrence, Singh, Rishi, Souied, Eric, Spinak, David J., Spital, Georg, Steinle, Nathan, Stern, Jeffrey, Stoller, Glenn, Stoltz, Robert, Stone, Cameron, Stone, Amy, Suan, Eric, Sugimoto, Masahiko, Sugita, Iichiro, Sun, Jennifer, Sun, Xiaodong, Suner, Ivan, Szalczer, Lajos, Szecsko, Timea, Tabassian, Ali, Tadayoni, Ramin, Takagi, Hitoshi, Takayama, Kei, Taleb, Alexandre, Talks, James, Tan, Gavin, Tanabe, Teruyo, Taylor, Stanford, Thach, Allen, Thompson, John, Tlucek, Paul, Torti, Robert, Tosheva Guneva, Daniela, Toth-Molnar, Edit, Uchiyama, Eduardo, Vajas, Attila, Varma, Deepali, Varsanyi, Balazs, Vassileva, Petja, Vaz-Pereira, Sara, Veith, Miroslav, Vela, Jose Ignacio, Viola, Francesco, Virgili, Gianni, Vogt, Gábor, Vorum, Henrik, Weber, Pamela, Wecke, Thoalf, Wee, Raymond, Weger, Martin, Weishaar, Paul, Wells, John A., Wickremasinghe, Sanjeewa, Williams, Thomas Reginald, Williams, Thomas, Williams, Geoff, Wolf, Armin, Wolfe, Jeremy, Wong, James, Wong, David, Wong, Ian, Wong, Robert, Wowra, Bogumil, Wykoff, Charles C., Wylęgała, Edward, Yang, Chang-Hao, Yasukawa, Tsutomu, Yates, Paul, Yilmaz, Gursel, Yiu, Glenn, Yoon, Young Hee, Yoreh, Barak, Yoshida, Shigeo, Yu, Hyeong Gon, Yu, Seung Young, Yurieva, Tatiana, Zacharias, Leandro, Zaczek Zakrzewska, Karolina, Zambrano, Alberto, Zatorska, Barbara, Zeolite, Carlos, Zheutlin, Jeffrey, Wong, Tien Y., Haskova, Zdenka, Asik, Kemal, Baumal, Caroline R., Csaky, Karl G., Ives, Jane A., Jaffe, Glenn J., Korobelnik, Jean-François, Lin, Hugh, Murata, Toshinori, Schlottmann, Patricio G., Seres, András I., Silverman, David, and Tang, Yannan
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- 2024
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3. Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial
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Abraham, Prema, Aderman, Christopher, Akiyama, Kunihiko, Alfaro, Daniel V., Ali, Fareed A., Amini, Payam, Anzalotta, Andres Emanuelli, Bátor, György, Batlle, Ivan, Berger, Adam, Bhandari, Ramanath, Bridges, William, Brinkmann, Christian, Brown, Jamin, Burgess, Stuart, Calzada, Jorge, Capone Jr., Antonio, Cervena, Dana, Charles, Steven, Chaudhry, Nauman, Chow, David, Clark, W. Lloyd, Conrad III, Paul, Cunningham, Matthew, Dadgostar, Hajir, Dessouki, Amr, Deupree, Dana, Devine, Christopher, Eichenbaum, David, Ernest, Jan, Feltgen, Nicolas, Fenberg, Moss, Ferrone, Philip, Frenkel, Ronald, Friedman, Scott, Gasperini, Julie, Gerstenblith, Adam, Ghorayeb, Ghassan, Giunta, Michel, Goff, Mitchell, Golas, Liliya, Googe Jr., Joseph M., Goren Fein, Jordana, Hagedorn, Curtis, Hagiwara, Akira, Hahn, Paul, Hairston, Richard, Handza, Jason, Hau, Vivienne, Hayashi, Ken, Heier, Jeffrey, Hershberger, Vrinda, Higgins, Patrick, Hirano, Yoshio, Honda, Shigeru, Ikegami, Yasuko, Ishida, Yuichiro, Ishikawa, Isao, Ishii, Kiyoshi, Jablon, Eric P., Jain, Atul, Kaji, Yuichi, Kapoor, Kapil, Kerényi, Ágnes, Kimura, Kazuhiro, Kishino, Genichiro, Kiss, Katalin, Kitaoka, Takashi, Klancnik, James M., Kobayashi, Namie, Kogo, Jiro, Korda, Vladimir, Kruger, Erik, Kusuhara, Sentaro, Lara, Wilfredo, Laud, Ketan, Lee, Seong, Luu, James, Marcus, Dennis, Mein, Calvin, Meleth, Annal, Milibák, Tibor, Mitamura, Yoshinori, Murata, Toshinori, Noge, Sumiyo, Onoe, Hajime, Osher, James, Papp, András, Parschauer, Justin, Patel, Sugat, Patel, Sunil, Pezda, Matthew, Pirouz, Ashkan, Prasad, Pradeep, Punjabi, Omar, Rao, Llewelyn, Roe, Richard, Schadlu, Ramin, Schneider, Eric, Shah, Ankur, Shah, Milan, Shah, Sandeep, Shah, Sumit, Sharma, Ashish, Sheth, Veeral, Shimura, Masahiko, Singerman, Lawrence, Spital, Georg, Stoltz, Robert, Suan, Eric, Suzuma, Kiyoshi, Takahashi, Hidenori, Takamura, Yoshihiro, Takeuchi, Masaru, Tan, Jeffrey, Thomas, Benjamin, Tóth,-Molnár, Edit, Ueda, Tetsuo, Ushida, Hiroaki, Vajas, Attila, Varma, Deepali, Varsányi, Balázs, Veith, Miroslav, Weber, Pamela, Wee, Raymond, Williams, Geoff, Yamada, Haruhiko, Yonekawa, Yoshihiro, Yoshida, Shigeo, Brown, David M, Boyer, David S, Do, Diana V, Wykoff, Charles C, Sakamoto, Taiji, Win, Peter, Joshi, Sunir, Salehi-Had, Hani, Seres, András, Berliner, Alyson J, Leal, Sergio, Vitti, Robert, Chu, Karen W, Reed, Kimberly, Rao, Rohini, Cheng, Yenchieh, Sun, Wei, Voronca, Delia, Bhore, Rafia, Schmidt-Ott, Ursula, Schmelter, Thomas, Schulze, Andrea, Zhang, Xin, Hirshberg, Boaz, Yancopoulos, George D, and Sivaprasad, Sobha
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- 2024
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4. Biosimilar Candidate CT-P42 in Diabetic Macular Edema: 24-Week Results from a Randomized, Active-Controlled, Phase III Study
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Wolf, Sebastian, Stanga, Paulo-Eduardo, Veselovsky, Milan, Veith, Miroslav, Papp, Andras, Mange, Shobhana, Kanta Mondal, Lakshmi, Romanczak, Dominika, Janco, Ladislav, Chauhan, Rohan, Romanowska-Dixon, Bożena, Eremina, Alena, Zavgorodnya, Nataliya, Dusova, Jaroslava, Sagong, Min, Kim, Sunghyun, Ahn, Keumyoung, Kim, Suyoung, Bae, Youngmin, Lee, Sangmi, Kang, Hyejin, and Brown, David M.
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- 2024
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5. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials
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Cole, Abosede O, Gerstenblith, Adam T, Kotagiri, Ajay, Edwards, Albert O, Zambrano, Alberto D, Eaton, Alexander M, Rubowitz, Alexander, Lyon, Alice T, Chiang, Allen, Ho, Allen, Hu, Allen Y, Guerami, Amir H, Dessouki, Amr L, de Carvalho, André Corrêa Maia, Emanuelli, Andrés, Chang, Andrew A, Antoszyk, Andrew N, Francone, Anibal Andrés, Prasad, Anita, Wolf, Armin, Khanani, Arshad M, Abbey, Ashkan Michael, Moulana, Asma, Wihelm, Barbara, Sikorski, Bartosz L, Kuppermann, Baruch D, Wolff, Benjamin, Jewart, Brian H, Do, Brian K, Chan-Kai, Brian T, Mein, Calvin, Hoyng, Carel B, Awh, Carl C, Regillio, Carl, Zeolite, Carlos, Baumal, Caroline R, Creuzot-Garcher, Catherine, Maury, Catherine Français, Wykoff, Charles C, Newell, Charles K, Jhaveri, Chirag, Lohmann, Chris P, Dinah, Christiana B, Ma, Colin, Crawford, Courtney, Parke, D Wilkin, Lavinsky, Daniel, Roth, Daniel, Pieramici, Dante J, Moshfeghi, Darius M, Levin, Darrin, Saperstein, David A, Brown, David, Gaucher, David, Lally, David R, Liao, David S, Brown, David Warren, Goldstein, Debra, Marcus, Dennis, Chan, Derek G, Dhoot, Dilsher, Tacite, Domingo, Zalewski, Dominik, Espana, Edgar M, Lad, Eleonora M, Souied, Eric H, Suan, Eric P, Eting, Eva, Sola, Federico Furno, de Bats, Flore, Bandello, Francesco, Gómez-Ulla, Francisco, Devin, François, Holz, Frank G, Chen, Fred K, Makkouk, Fuad, Dyer, Gawain, Spital, George, Staurenghi, Giovanni, Stoller, Glenn, Cousins, Gwen, Salehi-Had, Hani, Agostini, Hansjürgen, Eleftheriadis, Haralabos, Weiss, Harold, Sultan, Harris C, Massé, Hélène, Pearce, Ian, Dias, Indra, Barbazetto, Irene, Rosenblatt, Irit, Suñer, Ivan J, Kovach, Jaclyn L, Kaluzny, Jakub, Borthwick, James, Howard, James G, Wong, James, Ernest, Jan, Němčanský, Jan, Ysasaga, Jason Edward, Handza, Jason M, Moreno, Javier Antonio Montero, Korobelnik, Jean-François, Heier, Jeffrey S, Arnold, Jennifer J, Brown, Jeremiah, Bafalluy, Joaquin, Pearlman, Joel, Pitcher, John D, Kitchens, John, Carlson, John P, Gilhotra, Jolly, Fein, Jordana, Monés, Jordi M, Luna, José Domingo, Moreno, José María Ruiz, Coney, Joseph M, Sallum, Juliana Maria Ferraz, Olsen, Karl R, Blobner, Katharina, Macoul, Katherine A, Oh, Kean T, Malik, Khurram Javed, Hattenbach, Lars-Olof, Kodjikian, Laurent, Neto, Laurentino Biccas, Singerman, Lawrence J, Altay, Lebriz, Sheck, Leo-H, Feiner, Leonard, Harris, Lindsey D, Chishold, Lionel D, Rao, Llewelyn J, Nehemy, Márcio Bittar, Elizalde, Maria Jose Capella, Gamulescu, Maria-Andreea, Saravia, Mario J, Johnson, Mark W, McKibbin, Martin, Maccumber, Mathew, Vidosevich, Matko, Ohr, Matthew P, Samuel, Michael A, Singer, Michael A, Cassell, Michael, Dollin, Michael, Elman, Michael J, Ip, Michael S, Goldstein, Michaella, Busquets, Miguel, Mititelu, Mihai, Shah, Milan, Veith, Miroslav, Fineman, Mitchell, Varano, Monica, Christmas, Nancy, Steinle, Nathan C, Chaudhry, Nauman, Chinskey, Nicholas D, Eter, Nicole, London, Nikolas J S, Mathalone, Nurit, Schlottmann, Patricio G, Coady, Patrick, Higgins, Patrick M, Raskauskas, Paul A, Yates, Paul A, Bernstein, Paul, Mitchell, Paul, Monsour, Paul, Raphaelian, Paul V, Stanga, Paulo E, Stodulka, Pavel, Issa, Peter Charbel, Pavan, Peter, Ferrone, Phil J, Oleksy, Piotr, Abraham, Prema, Mruthyunjaya, Prithvi, Nguyen, Quan Dong, Reddy, Rahul K, Khurana, Rahul N, Tuli, Raman, Tadayoni, Ramin, Katz, Randy Steven, Arora, Rashi, Schlingemann, Reinier O, Rosen, Richard B, Gale, Richard, Scartozzi, Richard, Isernharge, Ricky, Singh, Rishi P, Stoltz, Robert A, Avery, Robert L, Wirthlin, Robert S, Guymer, Robyn, Goldberg, Roger A, Frenkel, Ronald, Belfort, Rubens Jr, Mohand-Said, Saddek, Grisanti, Salvatore, Razavi, Sam, Fraser-Bell, Samantha, Shah, Sandeep N, Wickremasinghe, Sanjeewa, Haug, Sara Joy, Adrean, Sean D, Priglinger, Siegfried G, Esposti, Simona Degli, Guest, Stephen, Huddleston, Stephen, Itty, Sujit, Moon, Suk Jin, Bhatia, Sumit P, Gupta, Sunil, Patel, Sunil S, Garg, Sunir J, Joshi, Sunir, Nghiem-Buffet, Sylvia, Johnson, T Mark, Jaouni, Tareq, Ach, Thomas, Williams, Thomas R, Sheidow, Thomas, Cleland, Timothy P, You, Timothy T, Peto, Tunde, Konidaris, Vasileios, Gonzalez, Victor H, Korda, Vladimir, Freeman, William R, Bridges, William Z, Barak, Yoreh, Zagorski, Zbigniew, Yehoshua, Zohar, Dubska, Zora, Rosenfeld, Philip J, Guymer, Robyn H, Boyer, David, Grossi, Federico, Korobelnik, Jean-Francois, Slakter, Jason S, Waheed, Nadia K, Metlapally, Ravi, Steinle, Nathan, Francone, Anibal A, Hu, Allen, Deschatelets, Pascal, Francois, Cedric, Bliss, Caleb, Monés, Jordi, and Ribeiro, Ramiro
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- 2023
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6. Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial
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Se Joon Woo, Srinivas R Sadda, Min Sagong, Cheolmin Yun, Edward Wylegala, Sunil Patel, Miroslav Veith, Jan Ernest, Jan Studnička, Attila Vajas, Inkyung Oh, Mario Bradvica, Michal Orski, Sergei Astakhov, Edit Tóth-Molnár, Adrienne Csutak, Lajos Enyedi, Wooree Choi, and Hyerin Jang
- Subjects
Ophthalmology ,RE1-994 - Abstract
Background/aims To evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of SB15 versus reference aflibercept (AFL), and switching from AFL to SB15 in neovascular age-related macular degeneration (nAMD).Design Prospective, double-masked, randomised, phase 3 trial.Methods Participants with nAMD were randomised 1:1 to receive SB15 (N=224 participants) or AFL (N=225). At week 32, participants either continued on SB15 (SB15/SB15, N=219) or AFL (AFL/AFL, N=108), or switched from AFL to SB15 (AFL/SB15, N=111). This manuscript reports 1-year and switching results of secondary efficacy endpoints such as changes from baseline to week 56 in best-corrected visual acuity (BCVA), central subfield thickness (CST, from internal limiting membrane (ILM) to retinal pigment epithelium), and total retinal thickness (TRT, from ILM to Bruch’s membrane). Additional endpoints included safety, PK and immunogenicity.Results Efficacy results were comparable between groups. The least squares mean (LSmean) change in BCVA from baseline to week 56 was 7.4 letters for SB15/SB15 and 7.0 letters for AFL/AFL (difference (95% CI)=0.4 (−2.5 to 3.2)). The LSmean changes from baseline to week 56 in CST and TRT were −119.2 µm and −132.4 µm for SB15/SB15 and −126.6 µm and −136.3 µm for AFL/AFL, respectively (CST: difference (95% CI)=7.4 µm (−6.11 to 20.96); TRT: difference (95% CI)=3.9 µm (−18.35 to 26.10)). Switched and non-switched participants showed similar LSmean changes in BCVA from baseline to week 56 (AFL/SB15, 7.9 letters vs AFL/AFL, 7.8 letters; difference (95% CI)=0.0 (−2.8 to 2.8)). Safety, PK and immunogenicity were comparable between groups.Conclusions Efficacy, safety, PK and immunogenicity were comparable between SB15 and AFL and between switched and non-switched participants.
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- 2023
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7. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials
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Aaberg, Thomas, Jr, Abbey, Ashkan, Abdulaeva, Elmira, Abengoechea, Santiago, Abraham, Prema, Ach, Thomas, Adams, Serrhel, Adan Civera, Alfredo, Adrean, Sean, Agostini, Hansjurgen, Alam, Suhail, Alezzandrini, Arturo, Alfaro, Virgil, Aliseda, Daniel, Almony, Arghavan, Amat, Pedro, Amini, Payam, Antoszyk, Andrew, Arias, Luis, Asaria, Riaz, Avila, Marcos, Awh, Carl C, Bafalluy, Joaquin, Baker, Carl, Bandello, Francesco, Barakat, Mark, Barraza, Karen, Bator, Gyorgy, Baumal, Caroline, Belfort Jr, Rubens, Bergstrom, Chris, Bertolucci, George, Bochow, Thomas, Bolz, Matthias, Borcz, Emilia, Bordon, Arnaldo, Boyer, David, Bratko, Galina, Brent, Michael, Brown, Jamin, Brown, David M, Budzinskaya, Maria, Buffet, Sylvia, Burgess, Stuart, Burton, Ben, Busquets, Miguel, Cabrera, Francisco, Cagini, Carlo, Calzada, Jorge, Campochiaro, Peter, Carlson, John, Castellarin, Alessandro, Cava, Carlos, Chaikitmongkol, Voraporn, Chan, Clement, Chang, Emmanuel, Chang, Jonathan, Chang, Andrew, Charles, Steve, Chaudhry, Nauman, Chee, Caroline, Chen, Judy, Chen, Fred, Chen, Shih-Jen, Cheong-Leen, Richard, Chiang, Allen, Chittum, Mark, Chow, David, Connolly, Brian, Cornut, Pierre Loic, Csaky, Karl, Danzig, Carl, Das, Arup, Daskalov, Vesselin, Desco, Carmen, Dessouki, Amr, Dickinson, John, Do, Brian, Dollin, Michael, Dugel, Pravin, Dusova, Jaroslava, Eichenbaum, David, Eldem, Bora, Engstrom, Robert, Ernest, Jan, Escobar, Joan Josep, Esposti, Simona, Eter, Nicole, Falk, Naomi, Farkas, Andrej, Feiner, Leonard, Feltgen, Nicolas, Fernandez, Carlos, Fernandez Vega, Alvaro, Ferrone, Philip, Figueira, Joao, Figueroa, Marta, Findl, .Oliver, Fine, Howard, Fortun, Jorge, Fox, Gregory M, Foxman, Scott, Framme, Carsten, Fraser-Bell, Samantha, Fu, Arthur, Fukutomi, Akira, Fung, Nicholas, Furno Sola, Federico, Gallego-Pinazo, Roberto, Garcia, Renata, Garcia-Layana, Alfredo, Gawecki, Maciej, George, Sheen, Ghanchi, Faruque, Ghorayeb, Ghassan, Goldberg, Roger, Goldstein, Michaella, Gomes, Nuno, Gomez Ulla, Francisco, Gonzalez, Victor, Greven, Craig, Gupta, Sunil, Guzman, Miguel, Harris, Martin, Hatz, Katja, Hau, Vivienne, Hau, Vincent, Hayashi, Ken, Heier, Jeffrey, Herba, Ewa, Hershberger, Vrinda, Higgins, Patrick, Hirakata, Akito, Ho, Allen, Holekamp, Nancy, Honda, Shigeru, Hsu, Jason, Hu, Allen, Hurcikova, Maria, Ikeda, Yasuhiro, Isernhagen, Ricky, Ito, Yasuki, Jackson, Tim, Jacoby, Rachael, Jafree, Afsar, Javey, Golnaz, Javid, Cameron, Jhaveri, Chirag, Johnson, Mark, Kacerík, Marek, Kaluzny, Jakub, Kampik, Daniel, Kang, Se Woong, Kapoor, Kapil, Karabas, Levent, Kawasaki, Tsutomu, Kerenyi, Agnes, Khanani, Arshad, Khurana, Rahul, Kim, Brian, Kimura, Kazuhiro, Kishino, Genichiro, Kitano, Shigehiko, Klein-Mascia, Kendra, Kokame, Gregg, Korobelnik, Jean Francois, Kulikov, Alexey, Kuriyan, Ajay, Kwong, Henry, Kwun, Robert, Lai, Timothy, Lai, Chi-Chun, Laird, Philip, Lalonde, Laurent, Lanzetta, Paolo, Larsen, Michael, Laugesen, Caroline, Lavinsky, Daniel, Lebreton, Olivier, Lee, Seong, Levy, Jaime, Lipkova, Blandina, Liu, Mimi, Liu, Judy, Lohmann, Chris P, London, Nikolas, Lorenz, Katrin, Lotery, Andrew, Lozano Rechy, David, Lujan, Silvio, Ma, Patrick, Maeno, Takatoshi, Mahmood, Sajjad, Makkouk, Fuad, Malik, Khurram, Marcus, Dennis, Margherio, Alan, Mastropasqua, Leonardo, Maturi, Raj, McCabe, Frank, McKibbin, Martin, Mehta, Hemal, Menon, Geeta, Mentes, Jale, Michalska-Malecka, Katarzyna, Misheva, Aneta, Mitamura, Yoshinori, Mitchell, Paul, Modi, Yasha, Mohamed, Quresh, Montero, Javier, Moore, Jeffrey, Morales Canton, Virgilio, Morori-Katz, Haia, Morugova, Tatiana, Murakami, Tomoaki, Muzyka-Wozniak, Maria, Nardi, Marco, Nemcansky, Jan, Nester-Ostrowska, Kamila, Neto, Julio, Newell, Charles, Nicolo, Massimo, Nielsen, Jared, Noda, Kousuke, Obana, Akira, Ogata, Nahoko, Oh, Hideyasu, Oh, Kean, Ohr, Matthew, Oleksy, Piotr, Oliver, Scott, Olivier, Sebastien, Osher, James, Ozcalişkan, Sehnaz, Ozturk, Banu, Papp, Andras, Park, Kyu Hyung, Parke, D Wilkin, Parravano, Maria Cristina, Patel, Sugat, Patel, Sunil, Pearce, Ian, Pearlman, Joel, Penha, Fernando, Perente, Irfan, Perkins, Stephen, Pertile, Grazia, Petkova, Iva, Peto, Tunde, Pieramici, Dante, Pollreisz, Andreas, Pongsachareonnont, Pear, Pozdeyeva, Nadezhda, Priglinger, Siegfried, Qureshi, Jawad, Raczynska, Dorota, Rajagopalan, Rajesh, Ramirez Estudillo, Juan, Raskauskas, Paul, Rathod, Rajiv, Razavi, Hessam, Regillo, Carl, Ricci, Federico, Rofagha, Soraya, Romanczak, Dominika, Romanowska-Dixon, Bożena, Rosberger, Daniel, Rosenblatt, Irit, Rosenblatt, Brett, Ross, Adam, Ruamviboonsuk, Paisan, Ruiz Moreno, Jose Maria, Salomão, Gustavo, Sandhu, Sukhpal, Sandner, Dirk, Sararols, Laura, Sawada, Osamu, Schadlu, Ramin, Schlottmann, Patricio, Schuart, Claudia, Seitz, Berthold, Seres, András, Sermet, Figen, Shah, Sandeep, Shah, Ankur, Shah, Rohan, Sharma, Sumit, Sheidow, Thomas, Sheth, Veeral, Shimouchi, Akito, Shimura, Masahiko, Sikorski, Bartosz, Silva, Rufino, Singer, Michael, Singerman, Lawrence, Singh, Rishi, Souied, Eric, Spinak, David J, Spital, Georg, Steinle, Nathan, Stern, Jeffrey, Stoller, Glenn, Stoltz, Robert, Stone, Cameron, Stone, Amy, Suan, Eric, Sugimoto, Masahiko, Sugita, Iichiro, Sun, Jennifer, Sun, Xiaodong, Suner, Ivan, Szalczer, Lajos, Szecsko, Timea, Tabassian, Ali, Tadayoni, Ramin, Takagi, Hitoshi, Takayama, Kei, Taleb, Alexandre, Talks, James, Tan, Gavin, Tanabe, Teruyo, Taylor, Stanford, Thach, Allen, Thompson, John, Tlucek, Paul, Torti, Robert, Tosheva Guneva, Daniela, Toth-Molnar, Edit, Uchiyama, Eduardo, Vajas, Attila, Varma, Deepali, Varsanyi, Balazs, Vassileva, Petja, Vaz-Pereira, Sara, Veith, Miroslav, Vela, Jose Ignacio, Viola, Francesco, Virgili, Gianni, Vogt, Gábor, Vorum, Henrik, Weber, Pamela, Wecke, Thoalf, Wee, Raymond, Weger, Martin, Weishaar, Paul, Wells, John A, Wickremasinghe, Sanjeewa, Williams, Thomas Reginald, Williams, Thomas, Williams, Geoff, Wolf, Armin, Wolfe, Jeremy, Wong, James, Wong, David, Wong, Ian, Wong, Robert, Wowra, Bogumil, Wykoff, Charles C, Wylęgała, Edward, Yang, Chang-Hao, Yasukawa, Tsutomu, Yates, Paul, Yilmaz, Gursel, Yiu, Glenn, Yoon, Young Hee, Yoreh, Barak, Yoshida, Shigeo, Yu, Hyeong Gon, Yu, Seung Young, Yurieva, Tatiana, Zacharias, Leandro, Zaczek Zakrzewska, Karolina, Zambrano, Alberto, Zatorska, Barbara, Zeolite, Carlos, Zheutlin, Jeffrey, Abreu, Francis, Adamis, Anthony P, Basu, Karen, Eichenbaum, David A, Haskova, Zdenka, Lin, Hugh, Loewenstein, Anat, Mohan, Shaun, Pearce, Ian A, Sakamoto, Taiji, Schlottmann, Patricio G, Silverman, David, Sun, Jennifer K, and Willis, Jeffrey R
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- 2022
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8. Asymmetric response to ranibizumab in mixed choroidal neovascularization in a neovascular age-related macular degeneration diagnosed on OCT angiography – case report
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Martin Pencak and Miroslav Veith
- Subjects
Anti-VEGF ,Mixed CNV ,Age‐related macular degeneration ,Resistance ,Case report ,Ophthalmology ,RE1-994 - Abstract
Abstract Background To present a case report of a patient with a mixed choroidal neovascular membrane (CNV) with an asymmetric response to ranibizumab diagnosed on optical coherence tomography angiography (OCTa). Case presentation A 61-year-old male was referred to our department in September 2017 due to decreased vision in his left eye. Best-corrected visual acuity (BCVA) was 43 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the left eye. Macular edema was present in the left eye, and a mixed CNV was identified on the OCTa. Therapy with intravitreal ranibizumab was commenced. After 5 ranibizumab injections, the BCVA was 42 ETDRS letters, and considerable intraretinal edema was still present. OCTa showed a resolution of the type 2 lesion of the mixed CNV; however, the type 1 lesion had continued to grow. The patient was then switched to intravitreal aflibercept. After 3 monthly aflibercept injections, the BCVA improved to 53 ETDRS letters, and a reduction of the edema was observed on the optical coherence tomography (OCT). OCTa showed a decrease in both the area and vessel density in the type 1 lesion of the CNV. Therapy with aflibercept was continued; however, while the intraretinal edema continued to improve, atrophy developed in the macula and the BCVA worsened to 43 ETDRS letters. Conclusions Ranibizumab nonresponse in a neovascular age-related macular degeneration is not uncommon. However, to our knowledge, this is the first described case of an asymmetric response to ranibizumab in a mixed CNV. While the type 2 lesion of the CNV reacted swiftly to the ranibizumab therapy, the type 1 lesion continued to grow. As with some other cases of ranibizumab resistance, switching to aflibercept proved effective.
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- 2021
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9. Early disruption of photoreceptor cell architecture and loss of vision in a humanized pig model of usher syndromes
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Sophia Grotz, Jessica Schäfer, Kirsten A Wunderlich, Zdenka Ellederova, Hannah Auch, Andrea Bähr, Petra Runa‐Vochozkova, Janet Fadl, Vanessa Arnold, Taras Ardan, Miroslav Veith, Gianluca Santamaria, Georg Dhom, Wolfgang Hitzl, Barbara Kessler, Christian Eckardt, Joshua Klein, Anna Brymova, Joshua Linnert, Mayuko Kurome, Valeri Zakharchenko, Andrea Fischer, Andreas Blutke, Anna Döring, Stepanka Suchankova, Jiri Popelar, Eduardo Rodríguez‐Bocanegra, Julia Dlugaiczyk, Hans Straka, Helen May‐Simera, Weiwei Wang, Karl‐Ludwig Laugwitz, Luk H Vandenberghe, Eckhard Wolf, Kerstin Nagel‐Wolfrum, Tobias Peters, Jan Motlik, M Dominik Fischer, Uwe Wolfrum, and Nikolai Klymiuk
- Subjects
gene therapy ,impaired vision ,photoreceptor morphology ,pig model ,Usher syndrome ,Medicine (General) ,R5-920 ,Genetics ,QH426-470 - Abstract
Abstract Usher syndrome (USH) is the most common form of monogenic deaf‐blindness. Loss of vision is untreatable and there are no suitable animal models for testing therapeutic strategies of the ocular constituent of USH, so far. By introducing a human mutation into the harmonin‐encoding USH1C gene in pigs, we generated the first translational animal model for USH type 1 with characteristic hearing defect, vestibular dysfunction, and visual impairment. Changes in photoreceptor architecture, quantitative motion analysis, and electroretinography were characteristics of the reduced retinal virtue in USH1C pigs. Fibroblasts from USH1C pigs or USH1C patients showed significantly elongated primary cilia, confirming USH as a true and general ciliopathy. Primary cells also proved their capacity for assessing the therapeutic potential of CRISPR/Cas‐mediated gene repair or gene therapy in vitro. AAV‐based delivery of harmonin into the eye of USH1C pigs indicated therapeutic efficacy in vivo.
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- 2022
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10. Faricimab Treat-and-Extend for Diabetic Macular Edema
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Wong, Tien Y., primary, Haskova, Zdenka, additional, Asik, Kemal, additional, Baumal, Caroline R., additional, Csaky, Karl G., additional, Eter, Nicole, additional, Ives, Jane A., additional, Jaffe, Glenn J., additional, Korobelnik, Jean-François, additional, Lin, Hugh, additional, Murata, Toshinori, additional, Ruamviboonsuk, Paisan, additional, Schlottmann, Patricio G., additional, Seres, András I., additional, Silverman, David, additional, Sun, Xiaodong, additional, Tang, Yannan, additional, Wells, John A., additional, Yoon, Young Hee, additional, Wykoff, Charles C., additional, Aaberg, Thomas, additional, Abbey, Ashkan, additional, Abdulaeva, Elmira, additional, Abengoechea, Santiago, additional, Abraham, Prema, additional, Ach, Thomas, additional, Adams, Serrhel, additional, Adan Civera, Alfredo, additional, Adrean, Sean, additional, Agostini, Hansjurgen, additional, Alam, Suhail, additional, Alezzandrini, Arturo, additional, Alfaro, Virgil, additional, Aliseda, Daniel, additional, Almony, Arghavan, additional, Amat, Pedro, additional, Amini, Payam, additional, Antoszyk, Andrew, additional, Arias, Luis, additional, Asaria, Riaz, additional, Avila, Marcos, additional, Awh, Carl C., additional, Bafalluy, Joaquin, additional, Baker, Carl, additional, Bandello, Francesco, additional, Barakat, Mark, additional, Barraza, Karen, additional, Bator, Gyorgy, additional, Baumal, Caroline, additional, Belfort, Rubens, additional, Bergstrom, Chris, additional, Bertolucci, George, additional, Bochow, Thomas, additional, Bolz, Matthias, additional, Borcz, Emilia, additional, Bordon, Arnaldo, additional, Boyer, David, additional, Bratko, Galina, additional, Brent, Michael, additional, Brown, Jamin, additional, Brown, David M., additional, Budzinskaya, Maria, additional, Buffet, Sylvia, additional, Burgess, Stuart, additional, Burton, Ben, additional, Busquets, Miguel, additional, Cabrera, Francisco, additional, Cagini, Carlo, additional, Calzada, Jorge, additional, Campochiaro, Peter, additional, Carlson, John, additional, Castellarin, Alessandro, additional, Cava, Carlos, additional, Chaikitmongkol, Voraporn, additional, Chan, Clement, additional, Chang, Emmanuel, additional, Chang, Jonathan, additional, Chang, Andrew, additional, Charles, Steve, additional, Chaudhry, Nauman, additional, Chee, Caroline, additional, Chen, Judy, additional, Chen, Fred, additional, Chen, Shih-Jen, additional, Cheong-Leen, Richard, additional, Chiang, Allen, additional, Chittum, Mark, additional, Chow, David, additional, Connolly, Brian, additional, Cornut, Pierre Loic, additional, Csaky, Karl, additional, Danzig, Carl, additional, Das, Arup, additional, Daskalov, Vesselin, additional, Desco, Carmen, additional, Dessouki, Amr, additional, Dickinson, John, additional, Do, Brian, additional, Dollin, Michael, additional, Dugel, Pravin, additional, Dusova, Jaroslava, additional, Eichenbaum, David, additional, Eldem, Bora, additional, Engstrom, Robert, additional, Ernest, Jan, additional, Escobar, Joan Josep, additional, Esposti, Simona, additional, Falk, Naomi, additional, Farkas, Andrej, additional, Feiner, Leonard, additional, Feltgen, Nicolas, additional, Fernandez, Carlos, additional, Fernandez Vega, Alvaro, additional, Ferrone, Philip, additional, Figueira, Joao, additional, Figueroa, Marta, additional, Findl, Oliver, additional, Fine, Howard, additional, Fortun, Jorge, additional, Fox, Gregory M., additional, Foxman, Scott, additional, Framme, Carsten, additional, Fraser-Bell, Samantha, additional, Fu, Arthur, additional, Fukutomi, Akira, additional, Fung, Nicholas, additional, Furno Sola, Federico, additional, Gallego-Pinazo, Roberto, additional, Garcia, Renata, additional, Garcia-Layana, Alfredo, additional, Gawecki, Maciej, additional, George, Sheen, additional, Ghanchi, Faruque, additional, Ghorayeb, Ghassan, additional, Goldberg, Roger, additional, Goldstein, Michaella, additional, Gomes, Nuno, additional, Ulla, Francisco Gomez, additional, Gonzalez, Victor, additional, Greven, Craig, additional, Gupta, Sunil, additional, Guzman, Miguel, additional, Harris, Martin, additional, Hatz, Katja, additional, Hau, Vivienne, additional, Hau, Vincent, additional, Hayashi, Ken, additional, Heier, Jeffrey, additional, Herba, Ewa, additional, Hershberger, Vrinda, additional, Higgins, Patrick, additional, Hirakata, Akito, additional, Ho, Allen, additional, Holekamp, Nancy, additional, Honda, Shigeru, additional, Hsu, Jason, additional, Hu, Allen, additional, Hurcikova, Maria, additional, Ikeda, Yasuhiro, additional, Isernhagen, Ricky, additional, Ito, Yasuki, additional, Jackson, Tim, additional, Jacoby, Rachael, additional, Jafree, Afsar, additional, Javey, Golnaz, additional, Javid, Cameron, additional, Jhaveri, Chirag, additional, Johnson, Mark, additional, Kacerík, Marek, additional, Kaluzny, Jakub, additional, Kampik, Daniel, additional, Kang, Se Woong, additional, Kapoor, Kapil, additional, Karabas, Levent, additional, Kawasaki, Tsutomu, additional, Kerenyi, Agnes, additional, Khanani, Arshad, additional, Khurana, Rahul, additional, Kim, Brian, additional, Kimura, Kazuhiro, additional, Kishino, Genichiro, additional, Kitano, Shigehiko, additional, Klein-Mascia, Kendra, additional, Kokame, Gregg, additional, Korobelnik, Jean Francois, additional, Kulikov, Alexey, additional, Kuriyan, Ajay, additional, Kwong, Henry, additional, Kwun, Robert, additional, Lai, Timothy, additional, Lai, Chi-Chun, additional, Laird, Philip, additional, Lalonde, Laurent, additional, Lanzetta, Paolo, additional, Larsen, Michael, additional, Laugesen, Caroline, additional, Lavinsky, Daniel, additional, Lebreton, Olivier, additional, Lee, Seong, additional, Levy, Jaime, additional, Lipkova, Blandina, additional, Liu, Mimi, additional, Liu, Judy, additional, Lohmann, Chris P., additional, London, Nikolas, additional, Lorenz, Katrin, additional, Lotery, Andrew, additional, Lozano Rechy, David, additional, Lujan, Silvio, additional, Ma, Patrick, additional, Maeno, Takatoshi, additional, Mahmood, Sajjad, additional, Makkouk, Fuad, additional, Malik, Khurram, additional, Marcus, Dennis, additional, Margherio, Alan, additional, Mastropasqua, Leonardo, additional, Maturi, Raj, additional, McCabe, Frank, additional, McKibbin, Martin, additional, Mehta, Hemal, additional, Menon, Geeta, additional, Mentes, Jale, additional, Michalska-Malecka, Katarzyna, additional, Misheva, Aneta, additional, Mitamura, Yoshinori, additional, Mitchell, Paul, additional, Modi, Yasha, additional, Mohamed, Quresh, additional, Montero, Javier, additional, Moore, Jeffrey, additional, Morales Canton, Virgilio, additional, Morori-Katz, Haia, additional, Morugova, Tatiana, additional, Murakami, Tomoaki, additional, Muzyka-Wozniak, Maria, additional, Nardi, Marco, additional, Nemcansky, Jan, additional, Nester-Ostrowska, Kamila, additional, Neto, Julio, additional, Newell, Charles, additional, Nicolo, Massimo, additional, Nielsen, Jared, additional, Noda, Kousuke, additional, Obana, Akira, additional, Ogata, Nahoko, additional, Oh, Hideyasu, additional, Oh, Kean, additional, Ohr, Matthew, additional, Oleksy, Piotr, additional, Oliver, Scott, additional, Olivier, Sebastien, additional, Osher, James, additional, Ozcalışkan, Sehnaz, additional, Ozturk, Banu, additional, Papp, Andras, additional, Park, Kyu Hyung, additional, Parke, D. Wilkin, additional, Parravano, Maria Cristina, additional, Patel, Sugat, additional, Patel, Sunil, additional, Pearce, Ian, additional, Pearlman, Joel, additional, Penha, Fernando, additional, Perente, Irfan, additional, Perkins, Stephen, additional, Pertile, Grazia, additional, Petkova, Iva, additional, Peto, Tunde, additional, Pieramici, Dante, additional, Pollreisz, Andreas, additional, Pongsachareonnont, Pear, additional, Pozdeyeva, Nadezhda, additional, Priglinger, Siegfried, additional, Qureshi, Jawad, additional, Raczynska, Dorota, additional, Rajagopalan, Rajesh, additional, Ramirez Estudillo, Juan, additional, Raskauskas, Paul, additional, Rathod, Rajiv, additional, Razavi, Hessam, additional, Regillo, Carl, additional, Ricci, Federico, additional, Rofagha, Soraya, additional, Romanczak, Dominika, additional, Romanowska-Dixon, Bożena, additional, Rosberger, Daniel, additional, Rosenblatt, Irit, additional, Rosenblatt, Brett, additional, Ross, Adam, additional, Ruiz Moreno, Jose Maria, additional, Salomão, Gustavo, additional, Sandhu, Sukhpal, additional, Sandner, Dirk, additional, Sararols, Laura, additional, Sawada, Osamu, additional, Schadlu, Ramin, additional, Schlottmann, Patricio, additional, Schuart, Claudia, additional, Seitz, Berthold, additional, Seres, András, additional, Sermet, Figen, additional, Shah, Sandeep, additional, Shah, Ankur, additional, Shah, Rohan, additional, Sharma, Sumit, additional, Sheidow, Thomas, additional, Sheth, Veeral, additional, Shimouchi, Akito, additional, Shimura, Masahiko, additional, Sikorski, Bartosz, additional, Silva, Rufino, additional, Singer, Michael, additional, Singerman, Lawrence, additional, Singh, Rishi, additional, Souied, Eric, additional, Spinak, David J., additional, Spital, Georg, additional, Steinle, Nathan, additional, Stern, Jeffrey, additional, Stoller, Glenn, additional, Stoltz, Robert, additional, Stone, Cameron, additional, Stone, Amy, additional, Suan, Eric, additional, Sugimoto, Masahiko, additional, Sugita, Iichiro, additional, Sun, Jennifer, additional, Suner, Ivan, additional, Szalczer, Lajos, additional, Szecsko, Timea, additional, Tabassian, Ali, additional, Tadayoni, Ramin, additional, Takagi, Hitoshi, additional, Takayama, Kei, additional, Taleb, Alexandre, additional, Talks, James, additional, Tan, Gavin, additional, Tanabe, Teruyo, additional, Taylor, Stanford, additional, Thach, Allen, additional, Thompson, John, additional, Tlucek, Paul, additional, Torti, Robert, additional, Tosheva Guneva, Daniela, additional, Toth-Molnar, Edit, additional, Uchiyama, Eduardo, additional, Vajas, Attila, additional, Varma, Deepali, additional, Varsanyi, Balazs, additional, Vassileva, Petja, additional, Vaz-Pereira, Sara, additional, Veith, Miroslav, additional, Vela, Jose Ignacio, additional, Viola, Francesco, additional, Virgili, Gianni, additional, Vogt, Gábor, additional, Vorum, Henrik, additional, Weber, Pamela, additional, Wecke, Thoalf, additional, Wee, Raymond, additional, Weger, Martin, additional, Weishaar, Paul, additional, Wickremasinghe, Sanjeewa, additional, Williams, Thomas Reginald, additional, Williams, Thomas, additional, Williams, Geoff, additional, Wolf, Armin, additional, Wolfe, Jeremy, additional, Wong, James, additional, Wong, David, additional, Wong, Ian, additional, Wong, Robert, additional, Wowra, Bogumil, additional, Wylęgała, Edward, additional, Yang, Chang-Hao, additional, Yasukawa, Tsutomu, additional, Yates, Paul, additional, Yilmaz, Gursel, additional, Yiu, Glenn, additional, Yoreh, Barak, additional, Yoshida, Shigeo, additional, Yu, Hyeong Gon, additional, Yu, Seung Young, additional, Yurieva, Tatiana, additional, Zacharias, Leandro, additional, Zaczek Zakrzewska, Karolina, additional, Zambrano, Alberto, additional, Zatorska, Barbara, additional, Zeolite, Carlos, additional, and Zheutlin, Jeffrey, additional
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- 2023
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11. Asymmetric response to ranibizumab in mixed choroidal neovascularization in a neovascular age-related macular degeneration diagnosed on OCT angiography – case report
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Pencak, Martin and Veith, Miroslav
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- 2021
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12. The Burden of Macular Diseases in Central and Eastern Europe—Implications for Healthcare Systems
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Jaki Mekjavić, Polona, Jūratė Balčiūnienė, Vilma, Ćeklić, Lala, Ernest, Jan, Jamrichova, Zuzana, Zsolt Nagy, Zoltán, Petkova, Iva, Teper, Sławomir, Gardašević Topčić, Ivana, and Veith, Miroslav
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- 2019
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13. Diabetic Macular Edema – Diagnostics and Treatment Guidelines
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Ernest, Jan, primary, Němčanský, Jan, additional, Vysloužilová, Daniela, additional, Veith, Miroslav, additional, Studnička, Jan, additional, and Němec, Pavel, additional
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- 2023
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14. Descemet membrane endothelial keratoplasty with stromal rim (DMEK-S) in complicated patients
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Pavel Studeny, Miroslav Veith, and Deli Krizova
- Subjects
dmek-s ,lamellar keratoplasty ,endothelial dystrophy ,endothelial transplantation ,Medicine - Abstract
Purpose. To evaluate the outcomes of the hybrid technique of posterior lamellar keratoplasty (Descemets' membrane endothelial keratoplasty with stromal rim, DMEK-S) in eyes with multiple ocular pathologies. Methods: A retrospective case control study of the consecutive group of all eyes with combined ocular pathologies which underwent DMEK-S keratoplasty. We evaluated the number of pre- and post-operative complications; uncorrected distance visual acuity (UDVA); corrected distance visual acuity (CDVA) and endothelial cell density (ECD). The first group (Group 1 - 100 eyes) was compared to a control group of eyes (Group 2 - 145 eyes) without combined ocular pathologies, which were operated throughout the same time period. Comparisons were made in the 12th month of the follow-up. Results: Both the UDVA and the CDVA statistical values 12 months after the surgery were significantly better in Group 2. ECD was comparable in both groups. The number of complications during surgery was considerably higher in Group 1, where a certain type of complication occurred in 15 eyes (15%), while in Group 2 this complication occurred only in 9 eyes (6.2%). In Group 1 a slightly higher number of rebubbling cases (52% vs. 48.3%) occurred, as well as more than twice as many cases of primary graft failure (34% vs. 15.7%) compared to Group 2. Conclusion: DMEK-S - hybrid endothelial transplantation in complicated eyes in the evaluated group of patients led to a noticeable improvement of visual acuity. When compared to surgeries in uncomplicated eyes, DMEK-S results in a higher rate of postoperative complications, especially graft detachment and primary failure.
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- 2019
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15. 25-gauge vitrectomy and gas for the management of rhegmatogenous retinal detachment
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Miroslav Veith, Zbynek Stranak, Martin Pencak, Jana Vranova, and Pavel Studeny
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25-gauge ,vitrectomy ,retinal detachment ,rhegmatogenous ,gas ,oblique ,transconjunctival ,Medicine - Abstract
Aims: To evaluate the anatomical and functional results in patients with rhegmatogenous retinal detachment (RRD) who underwent 25-gauge pars plana vitrectomy (PPV) with gas tamponade. Materials and Methods: A retrospective evaluation of 126 eyes of 126 patients (79 men, 47 women) with RRD who underwent 25-gauge PPV with gas tamponade (13% C3F8 in 87 eyes, 20% SF6 in 39 eyes). 113 patients (89.7%), were operated on under local anaesthesia, 13 patients (10.3%) under general anaesthesia. Macula was detached in 85 eyes (67.5%). 53 eyes had pseudophakic RRD, 73 eyes were phakic. Anatomical success of the primary intervention, change in best corrected visual acuity (BCVA) and incidence of complications were assessed. An average follow-up period is 7.2 months (6-15). Results: With single operation, retinal attachment was achieved in 125 eyes (99.2%); the final anatomical success was 100%. The initial mean BCVA was 0.89 logMar (2.00 to 0.00); at the end of the follow-up period, it improved to 0.23logMAR (1.00 to -0.10), P < 0,0001. During the first post-intervention day, hypotony of the eye below 10 mmHg was observed in 1 patient (0.8%); on the contrary, intraocular pressure was temporarily increased to 25 mmHg and more in 36 patients (28.6%). Conclusion: The surgical treatment of RRD using 25-gauge PPV with expansive gas tamponade renders excellent anatomical results and improvement in BCVA. The incidence of complications and necessity of sclerotomy suturing are low.
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- 2019
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16. Long-term Results of a Combined Procedure of Cataract Surgery and Descemet Membrane Endothelial Keratoplasty With Stromal Rim
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Studeny, Pavel, Hlozankova, Katerina, Krizova, Deli, Netukova, Magdalena, Veith, Miroslav, Mojzis, Peter, and Piñero, David P.
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- 2020
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17. Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration
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Woo, Se Joon, primary, Bradvica, Mario, additional, Vajas, Attila, additional, Sagong, Min, additional, Ernest, Jan, additional, Studnicka, Jan, additional, Veith, Miroslav, additional, Wylegala, Edward, additional, Patel, Sunil, additional, Yun, Cheolmin, additional, Orski, Michal, additional, Astakhov, Sergei, additional, Tóth-Molnár, Edit, additional, Csutak, Adrienne, additional, Enyedi, Lajos, additional, Kim, Taehyung, additional, Oh, Inkyung, additional, Jang, Hyerin, additional, and Sadda, SriniVas R., additional
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- 2023
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18. Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial
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Brown, David M, Boyer, David S, Do, Diana V, Wykoff, Charles C, Sakamoto, Taiji, Win, Peter, Joshi, Sunir, Salehi-Had, Hani, Seres, András, Berliner, Alyson J, Leal, Sergio, Vitti, Robert, Chu, Karen W, Reed, Kimberly, Rao, Rohini, Cheng, Yenchieh, Sun, Wei, Voronca, Delia, Bhore, Rafia, Schmidt-Ott, Ursula, Schmelter, Thomas, Schulze, Andrea, Zhang, Xin, Hirshberg, Boaz, Yancopoulos, George D, Sivaprasad, Sobha, Abraham, Prema, Aderman, Christopher, Akiyama, Kunihiko, Alfaro, Daniel V., Ali, Fareed A., Amini, Payam, Anzalotta, Andres Emanuelli, Bátor, György, Batlle, Ivan, Berger, Adam, Bhandari, Ramanath, Bridges, William, Brinkmann, Christian, Brown, Jamin, Burgess, Stuart, Calzada, Jorge, Capone Jr., Antonio, Cervena, Dana, Charles, Steven, Chaudhry, Nauman, Chow, David, Clark, W. Lloyd, Conrad III, Paul, Cunningham, Matthew, Dadgostar, Hajir, Dessouki, Amr, Deupree, Dana, Devine, Christopher, Eichenbaum, David, Ernest, Jan, Feltgen, Nicolas, Fenberg, Moss, Ferrone, Philip, Frenkel, Ronald, Friedman, Scott, Gasperini, Julie, Gerstenblith, Adam, Ghorayeb, Ghassan, Giunta, Michel, Goff, Mitchell, Golas, Liliya, Googe Jr., Joseph M., Goren Fein, Jordana, Hagedorn, Curtis, Hagiwara, Akira, Hahn, Paul, Hairston, Richard, Handza, Jason, Hau, Vivienne, Hayashi, Ken, Heier, Jeffrey, Hershberger, Vrinda, Higgins, Patrick, Hirano, Yoshio, Honda, Shigeru, Ikegami, Yasuko, Ishida, Yuichiro, Ishikawa, Isao, Ishii, Kiyoshi, Jablon, Eric P., Jain, Atul, Kaji, Yuichi, Kapoor, Kapil, Kerényi, Ágnes, Kimura, Kazuhiro, Kishino, Genichiro, Kiss, Katalin, Kitaoka, Takashi, Klancnik, James M., Kobayashi, Namie, Kogo, Jiro, Korda, Vladimir, Kruger, Erik, Kusuhara, Sentaro, Lara, Wilfredo, Laud, Ketan, Lee, Seong, Luu, James, Marcus, Dennis, Mein, Calvin, Meleth, Annal, Milibák, Tibor, Mitamura, Yoshinori, Murata, Toshinori, Noge, Sumiyo, Onoe, Hajime, Osher, James, Papp, András, Parschauer, Justin, Patel, Sugat, Patel, Sunil, Pezda, Matthew, Pirouz, Ashkan, Prasad, Pradeep, Punjabi, Omar, Rao, Llewelyn, Roe, Richard, Schadlu, Ramin, Schneider, Eric, Shah, Ankur, Shah, Milan, Shah, Sandeep, Shah, Sumit, Sharma, Ashish, Sheth, Veeral, Shimura, Masahiko, Singerman, Lawrence, Spital, Georg, Stoltz, Robert, Suan, Eric, Suzuma, Kiyoshi, Takahashi, Hidenori, Takamura, Yoshihiro, Takeuchi, Masaru, Tan, Jeffrey, Thomas, Benjamin, Tóth, Edit, -Molnár, Ueda, Tetsuo, Ushida, Hiroaki, Vajas, Attila, Varma, Deepali, Varsányi, Balázs, Veith, Miroslav, Weber, Pamela, Wee, Raymond, Williams, Geoff, Yamada, Haruhiko, Yonekawa, Yoshihiro, and Yoshida, Shigeo
- Abstract
A high-dose formulation of intravitreal aflibercept (8 mg) could improve treatment outcomes in diabetic macular oedema (DMO) by requiring fewer injections than the standard comparator, aflibercept 2 mg. We report efficacy and safety results of aflibercept 8 mg versus 2 mg in patients with DMO.
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- 2024
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19. Incidence of adverse events after loading phase of the brolucizumab therapy of neovascular AMD: Real-life evidence in the Czech Republic
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Alexandr Stepanov, Jan Studnicka, Miroslav Veith, Pavel Nemec, Daniela Vyslouzilova, Michal Koubek, and Jan Nemcansky
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Ophthalmology ,General Medicine - Abstract
Aim To evaluate the incidence of ocular adverse events after loading phase of the brolucizumab therapy in patients with neovascular age-related macular degeneration (nAMD) in real-life clinical practice – in treatment-naive patients and in patients after switching from another anti-VEGF agent. Another aim was to evaluate treatment outcomes in patients with adverse events. Methods This is a multicentre, retrospective, observational study from 16 application centres in the Czech Republic. Patients diagnosed with nAMD were treated with brolucizumab in a fixed regimen of loading phase (3 injections administered at one-month intervals) and the mean follow-up period was 120 ± 10 days after the first injection. The incidence of adverse events and the development of best corrected visual acuity (BCVA) and central retinal thickness (CRT) in patients with complications were evaluated. A total of 1,098 eyes were followed up, of which 783 were treatment-naive and 315 eyes were after switching from another anti-VEGF agent. Results Adverse events were recorded in 42 eyes (3.83%), of which 30 eyes were treatment-naive (2.7%) and 12 eyes were post-switch (1.09%). The mean baseline BCVA ± SD was 56.7 ± 10.7 ETDRS chart letters in the group of patients with adverse events, 58.8 ± 10.1 letters in treatment-naive patients, and 51.4 ± 10.2 letters in patients after switch from another anti-VEGF agent. The mean baseline CRT ± SD was 432.2 ± 154.7 μm, being 435.8 ± 137.3 μm in treatment-naive patients and 424.5 ± 186.6 μm in patients after switch from another anti-VEGF agent. At the end of the follow-up, the mean BCVA ± SD was 53.4 ± 9.5 ETDRS charts letters in patients with adverse events, 55.6 ± 10 letters in treatment-naive patients, and 47.6 ± 10 letters in patients after switching from another anti-VEGF agent. The mean CRT ± SD at the end of the follow-up was 300.7 ± 115.7 μm in the total patient cohort, 285.2 ± 78.8 μm in treatment-naive patients and 334.5 ± 165.4 μm in patients after switching from another anti-VEGF agent. Conclusion We observed the development of adverse events in the form of intraocular inflammation or vasculitis with subsequent decrease in BCVA in 3.83% of cases after loading phase of the brolucizumab therapy. The decrease in BCVA was reversible in most cases after initiation of anti-inflammatory steroid treatment. From a functional and morphological point of view, we did not demonstrate any statistically significant difference between the groups of treatment-naive patients and patients after switching from another anti-VEGF agent.
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- 2022
20. Laser Vitreolysis for Vitreous Opacities: A Prospective Study
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Universidad de Alicante. Departamento de Óptica, Farmacología y Anatomía, Ernest, Adam, Veith, Miroslav, Dítě, Jakub, Vránová, Jana, Mojzis, Peter, Piñero, David P., Universidad de Alicante. Departamento de Óptica, Farmacología y Anatomía, Ernest, Adam, Veith, Miroslav, Dítě, Jakub, Vránová, Jana, Mojzis, Peter, and Piñero, David P.
- Abstract
Aim: The aim of this study is to evaluate the efficacy and safety of a YAG laser vitreolysis procedure used to remove bothersome vitreous opacities/floaters. Methods: The prospective clinical study included 42 eyes of 35 patients (age 32-81 years) with vitreous opacities generating visual disturbances. All patients were treated using the Ellex - Ultra Q Reflex YAG laser and underwent a complete eye examination before the laser vitreolysis and at 1, 3 and 6 months after the intervention. Changes in corrected distance visual acuity (CDVA), central retinal thickness (CRT), intraocular pressure (IOP) and patient’s subjective perception of disturbances were analysed. Results: The average number of laser shots was 118 (6 - 310 shots), with a total average energy of 3.8 mJ per laser shot (2.2 - 9 mJ). The laser intervention was performed only once in a total of 31 eyes (73.8%), whereas it was necessary to perform the intervention twice in 10 cases (23.8%). No significant differences in CDVA were detected during the whole follow-up (p>0.40). No significant changes were found either in CRT (p>0.32). Concerning IOP (p<0.001), it was reduced significantly immediately after the intervention, returning to the pre-intervention level afterwards. The analysis of the responses to the questionnaire revealed that there was a mean improvement in subjective visual symptoms according to patients of 71%. No complications were detected in the sample during the follow-up. Conclusion: Laser vitreolysis is a minimally invasive treatment, allowing a complete or partial elimination of vitreous opacities and leading to alleviation of patient’s disturbances.
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- 2023
21. Response to Aflibercept Therapy in Three Types of Choroidal Neovascular Membrane in Neovascular Age-Related Macular Degeneration: Real-Life Evidence in the Czech Republic
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Jan Nemcansky, Alexandr Stepanov, Michal Koubek, Miroslav Veith, Yun Min Klimesova, and Jan Studnicka
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Ophthalmology ,RE1-994 - Abstract
Purpose. To present a cohort of treatment-naive patients with the neovascular form of age-related macular degeneration (nAMD) treated with aflibercept in a fixed regimen and evaluate the treatment response of three types of choroidal neovascular membrane (CNV)—occult (Type 1), classic (Type 2), and minimally classic (Type 4). Methods. This was a multicentre, prospective, observational consecutive case series study. Patients diagnosed with three types of CNV of nAMD were treated in a fixed regimen (3 injections every 4 weeks, and then injections at 8 week intervals). The follow-up period was 48 weeks. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and spectral-domain optical coherence tomography (OCT). The measurements were taken at the baseline and then at 16, 32, and 48 weeks. Results. The treatment-naive group was composed of 135 eyes of 135 patients in the study. 61 eyes had Type 1 lesions of CNV, 50 eyes had Type 2 lesions, and 24 eyes had Type 4 lesions. Mean baseline BCVA ± SD for Type 1 lesions was 56.1 ± 10.8 ETDRS letters, and then 62.2 ± 12.9 letters, 61.2 ± 13.7 letters, and 62.8 ± 15.1 letters at 16, 32, and 48 weeks, respectively. Mean baseline CRT ± SD for Type 1 lesions was 442.4 ± 194.9 μm, and then 302.5 ± 144.4 μm, 299.7 ± 128.5 μm, and 277.7 ± 106.5 μm at 16, 32, and 48 weeks, respectively. Mean baseline BCVA ± SD for Type 2 lesions was 55.6 ± 9.9 ETDRS letters, and then 62.5 ± 11.1 letters, 60.7 ± 13.0 letters, and 62.5 ± 14.2 letters at 16, 32, and 48 weeks, respectively. Mean baseline CRT ± SD. For Type 4 lesions mean baseline BCVA ± SD was 56.7 ± 9.0 ETDRS letters, and then 59.1 ± 10.6 letters, 59.5 ± 11.4 letters, and 59.2 ± 12.6 letters at 16, 32, and 48 weeks respectively. Mean baseline CRT ± SD for Type 4 lesions was 492.1 ± 187.0 μm, and then 333.3 ± 137.5 μm, 354.4 ± 175.0 μm, and 326.7 ± 122.4 μm at 16, 32, and 48 weeks respectively. All these changes were statistically significant (p
- Published
- 2019
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22. Effect of baseline central retinal thickness on the results of treatment of diabetic macular edema with aflibercept: Real-Life Evidence in the Czech Republic
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Jan Němčanský, Alexandr Stěpanov, Miroslav Veith, Michal Koubek, Adam Kopecký, Sabina Němčanská, David Beran, and Jan Studnička
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Ophthalmology ,Diabetic Retinopathy ,Receptors, Vascular Endothelial Growth Factor ,Ranibizumab ,Recombinant Fusion Proteins ,Intravitreal Injections ,Diabetes Mellitus ,Visual Acuity ,Humans ,Angiogenesis Inhibitors ,Macular Edema ,Tomography, Optical Coherence ,Czech Republic - Abstract
Aim: Presentation of the 1-year results of aflibercept treatment in patients suffering from diabetic macular edema (DME) and comparison of the response to treatment of patients with different baseline central retinal thickness (CRT). Methods: This was a multicentre, retrospective observational study of a series of cases. Patients with DME were treated in a fixed regimen (5 injections at 1-monthly intervals and then injections at 2-monthly intervals). The period of follow-up was 12 months. The development of best corrected visual acuity (BCVA) and CRT was evaluated. Measurements were performed prior to the commencement of treatment and then after 4, 6, 8, 10, and 12 months. Results: The therapeutically naive group consisted of 82 eyes of 79 patients. The total cohort of patients was divided into 3 groups according to the baseline values of CRT. The first group was composed of 28 eyes with baseline CRT < 450 μm (34.1%), the second included 25 eyes with CRT in the range of 450–550 μm (30.5%), and the third group consisted of 29 eyes with baseline CRT > 550 μm (35.4%). The average baseline BCVA and SD in the first group was 66 ±7.1 letters ETDRS optotypes, and then 70 ±7 letters, 69.6 ±7.3 letters, and 71.3 ±7 letters at the follow-ups after 4, 8, and 12 months. The average baseline value of CRT and SD in the first group was 379 ±48.6 μm, and then 337.1 ±76.5 μm, 320.2 ±74.1 μm, and 315.1 ±62.2 μm after 4, 8, and 12 months. The average baseline BCVA and SD in the second group was 64.1 ±9.7 ETDRS letters, and then 66.9 ±10 letters, 70 ±9.9 letters, and 70.5 ±11.5 letters after 4, 8, and 12 months. The average baseline value of CRT and SD in the second group was 497.4 ±76.4 μm, and then 376.5 ±106.1 μm, 360.8 ±70 μm, and 351.3 ±91.3 μm after 4, 8, and 12 months. In the third group, the average baseline value of BCVA and SD was 59.7 ±10.4 ETDRS letters, and then 65 ±10.6 letters, 64.8 ±9.6 letters, and 67 ±10 letters after 4, 8, and 12 months. The average baseline value of CRT and SD in the third group was 639.4 ±79.6 μm, and then 396.7 ±147.1 μm, 416.9 ±139.8 μm, and 368.5 ±109.9 μm after 4, 8, and 12 months. All these changes were statistically significant (p < 0.05). Conclusion: Aflibercept treatment in a fixed regimen in patients suffering from DME results in a statistically significant improvement in BCVA and a decrease in CRT in the first year of treatment. Patients with a higher baseline CRT showed the best anatomical and functional results of the 1-year treatment with aflibercept.
- Published
- 2022
23. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials
- Author
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Charles C Wykoff, Francis Abreu, Anthony P Adamis, Karen Basu, David A Eichenbaum, Zdenka Haskova, Hugh Lin, Anat Loewenstein, Shaun Mohan, Ian A Pearce, Taiji Sakamoto, Patricio G Schlottmann, David Silverman, Jennifer K Sun, John A Wells, Jeffrey R Willis, Ramin Tadayoni, Thomas Aaberg, Ashkan Abbey, Elmira Abdulaeva, Santiago Abengoechea, Prema Abraham, Thomas Ach, Serrhel Adams, Alfredo Adan Civera, Sean Adrean, Hansjurgen Agostini, Suhail Alam, Arturo Alezzandrini, Virgil Alfaro, Daniel Aliseda, Arghavan Almony, Pedro Amat, Payam Amini, Andrew Antoszyk, Luis Arias, Riaz Asaria, Marcos Avila, Carl C Awh, Joaquin Bafalluy, Carl Baker, Francesco Bandello, Mark Barakat, Karen Barraza, Gyorgy Bator, Caroline Baumal, Rubens Belfort Jr, Chris Bergstrom, George Bertolucci, Thomas Bochow, Matthias Bolz, Emilia Borcz, Arnaldo Bordon, David Boyer, Galina Bratko, Michael Brent, Jamin Brown, David M Brown, Maria Budzinskaya, Sylvia Buffet, Stuart Burgess, Ben Burton, Miguel Busquets, Francisco Cabrera, Carlo Cagini, Jorge Calzada, Peter Campochiaro, John Carlson, Alessandro Castellarin, Carlos Cava, Voraporn Chaikitmongkol, Clement Chan, Emmanuel Chang, Jonathan Chang, Andrew Chang, Steve Charles, Nauman Chaudhry, Caroline Chee, Judy Chen, Fred Chen, Shih-Jen Chen, Richard Cheong-Leen, Allen Chiang, Mark Chittum, David Chow, Brian Connolly, Pierre Loic Cornut, Karl Csaky, Carl Danzig, Arup Das, Vesselin Daskalov, Carmen Desco, Amr Dessouki, John Dickinson, Brian Do, Michael Dollin, Pravin Dugel, Jaroslava Dusova, David Eichenbaum, Bora Eldem, Robert Engstrom, Jan Ernest, Joan Josep Escobar, Simona Esposti, Nicole Eter, Naomi Falk, Andrej Farkas, Leonard Feiner, Nicolas Feltgen, Carlos Fernandez, Alvaro Fernandez Vega, Philip Ferrone, Joao Figueira, Marta Figueroa, Oliver Findl, Howard Fine, Jorge Fortun, Gregory M Fox, Scott Foxman, Carsten Framme, Samantha Fraser-Bell, Arthur Fu, Akira Fukutomi, Nicholas Fung, Federico Furno Sola, Roberto Gallego-Pinazo, Renata Garcia, Alfredo Garcia-Layana, Maciej Gawecki, Sheen George, Faruque Ghanchi, Ghassan Ghorayeb, Roger Goldberg, Michaella Goldstein, Nuno Gomes, Francisco Gomez Ulla, Victor Gonzalez, Craig Greven, Sunil Gupta, Miguel Guzman, Martin Harris, Katja Hatz, Vivienne Hau, Vincent Hau, Ken Hayashi, Jeffrey Heier, Ewa Herba, Vrinda Hershberger, Patrick Higgins, Akito Hirakata, Allen Ho, Nancy Holekamp, Shigeru Honda, Jason Hsu, Allen Hu, Maria Hurcikova, Yasuhiro Ikeda, Ricky Isernhagen, Yasuki Ito, Tim Jackson, Rachael Jacoby, Afsar Jafree, Golnaz Javey, Cameron Javid, Chirag Jhaveri, Mark Johnson, Marek Kacerík, Jakub Kaluzny, Daniel Kampik, Se Woong Kang, Kapil Kapoor, Levent Karabas, Tsutomu Kawasaki, Agnes Kerenyi, Arshad Khanani, Rahul Khurana, Brian Kim, Kazuhiro Kimura, Genichiro Kishino, Shigehiko Kitano, Kendra Klein-Mascia, Gregg Kokame, Jean Francois Korobelnik, Alexey Kulikov, Ajay Kuriyan, Henry Kwong, Robert Kwun, Timothy Lai, Chi-Chun Lai, Philip Laird, Laurent Lalonde, Paolo Lanzetta, Michael Larsen, Caroline Laugesen, Daniel Lavinsky, Olivier Lebreton, Seong Lee, Jaime Levy, Blandina Lipkova, Mimi Liu, Judy Liu, Chris P Lohmann, Nikolas London, Katrin Lorenz, Andrew Lotery, David Lozano Rechy, Silvio Lujan, Patrick Ma, Takatoshi Maeno, Sajjad Mahmood, Fuad Makkouk, Khurram Malik, Dennis Marcus, Alan Margherio, Leonardo Mastropasqua, Raj Maturi, Frank McCabe, Martin McKibbin, Hemal Mehta, Geeta Menon, Jale Mentes, Katarzyna Michalska-Malecka, Aneta Misheva, Yoshinori Mitamura, Paul Mitchell, Yasha Modi, Quresh Mohamed, Javier Montero, Jeffrey Moore, Virgilio Morales Canton, Haia Morori-Katz, Tatiana Morugova, Tomoaki Murakami, Maria Muzyka-Wozniak, Marco Nardi, Jan Nemcansky, Kamila Nester-Ostrowska, Julio Neto, Charles Newell, Massimo Nicolo, Jared Nielsen, Kousuke Noda, Akira Obana, Nahoko Ogata, Hideyasu Oh, Kean Oh, Matthew Ohr, Piotr Oleksy, Scott Oliver, Sebastien Olivier, James Osher, Sehnaz Ozcalişkan, Banu Ozturk, Andras Papp, Kyu Hyung Park, D Wilkin Parke, Maria Cristina Parravano, Sugat Patel, Sunil Patel, Ian Pearce, Joel Pearlman, Fernando Penha, Irfan Perente, Stephen Perkins, Grazia Pertile, Iva Petkova, Tunde Peto, Dante Pieramici, Andreas Pollreisz, Pear Pongsachareonnont, Nadezhda Pozdeyeva, Siegfried Priglinger, Jawad Qureshi, Dorota Raczynska, Rajesh Rajagopalan, Juan Ramirez Estudillo, Paul Raskauskas, Rajiv Rathod, Hessam Razavi, Carl Regillo, Federico Ricci, Soraya Rofagha, Dominika Romanczak, Bożena Romanowska-Dixon, Daniel Rosberger, Irit Rosenblatt, Brett Rosenblatt, Adam Ross, Paisan Ruamviboonsuk, Jose Maria Ruiz Moreno, Gustavo Salomão, Sukhpal Sandhu, Dirk Sandner, Laura Sararols, Osamu Sawada, Ramin Schadlu, Patricio Schlottmann, Claudia Schuart, Berthold Seitz, András Seres, Figen Sermet, Sandeep Shah, Ankur Shah, Rohan Shah, Sumit Sharma, Thomas Sheidow, Veeral Sheth, Akito Shimouchi, Masahiko Shimura, Bartosz Sikorski, Rufino Silva, Michael Singer, Lawrence Singerman, Rishi Singh, Eric Souied, David J Spinak, Georg Spital, Nathan Steinle, Jeffrey Stern, Glenn Stoller, Robert Stoltz, Cameron Stone, Amy Stone, Eric Suan, Masahiko Sugimoto, Iichiro Sugita, Jennifer Sun, Xiaodong Sun, Ivan Suner, Lajos Szalczer, Timea Szecsko, Ali Tabassian, Hitoshi Takagi, Kei Takayama, Alexandre Taleb, James Talks, Gavin Tan, Teruyo Tanabe, Stanford Taylor, Allen Thach, John Thompson, Paul Tlucek, Robert Torti, Daniela Tosheva Guneva, Edit Toth-Molnar, Eduardo Uchiyama, Attila Vajas, Deepali Varma, Balazs Varsanyi, Petja Vassileva, Sara Vaz-Pereira, Miroslav Veith, Jose Ignacio Vela, Francesco Viola, Gianni Virgili, Gábor Vogt, Henrik Vorum, Pamela Weber, Thoalf Wecke, Raymond Wee, Martin Weger, Paul Weishaar, Sanjeewa Wickremasinghe, Thomas Reginald Williams, Thomas Williams, Geoff Williams, Armin Wolf, Jeremy Wolfe, James Wong, David Wong, Ian Wong, Robert Wong, Bogumil Wowra, Edward Wylęgała, Chang-Hao Yang, Tsutomu Yasukawa, Paul Yates, Gursel Yilmaz, Glenn Yiu, Young Hee Yoon, Barak Yoreh, Shigeo Yoshida, Hyeong Gon Yu, Seung Young Yu, Tatiana Yurieva, Leandro Zacharias, Karolina Zaczek Zakrzewska, Alberto Zambrano, Barbara Zatorska, Carlos Zeolite, and Jeffrey Zheutlin
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Male ,Vascular Endothelial Growth Factor A ,Diabetic Retinopathy ,Recombinant Fusion Proteins ,Visual Acuity ,Angiogenesis Inhibitors ,General Medicine ,Middle Aged ,Drug Administration Schedule ,Angiopoietin-2 ,Receptors, Vascular Endothelial Growth Factor ,Treatment Outcome ,Double-Blind Method ,Antibodies, Bispecific ,Intravitreal Injections ,Edema ,Humans ,Female ,Macula Lutea ,Aged - Abstract
To reduce treatment burden and optimise patient outcomes in diabetic macular oedema, we present 1-year results from two phase 3 trials of faricimab, a novel angiopoietin-2 and vascular endothelial growth factor-A bispecific antibody.YOSEMITE and RHINE were randomised, double-masked, non-inferiority trials across 353 sites worldwide. Adults with vision loss due to centre-involving diabetic macular oedema were randomly assigned (1:1:1) to intravitreal faricimab 6·0 mg every 8 weeks, faricimab 6·0 mg per personalised treatment interval (PTI), or aflibercept 2·0 mg every 8 weeks up to week 100. PTI dosing intervals were extended, maintained, or reduced (every 4 weeks up to every 16 weeks) based on disease activity at active dosing visits. The primary endpoint was mean change in best-corrected visual acuity at 1 year, averaged over weeks 48, 52, and 56. Efficacy analyses included the intention-to-treat population (non-inferiority margin 4 Early Treatment Diabetic Retinopathy Study [ETDRS] letters); safety analyses included patients with at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (YOSEMITE NCT03622580 and RHINE NCT03622593).3247 patients were screened for eligibility in YOSEMITE (n=1532) and RHINE (n=1715). After exclusions, 940 patients were enrolled into YOSEMITE between Sept 5, 2018, and Sept 19, 2019, and 951 patients were enrolled into RHINE between Oct 9, 2018, and Sept 20, 2019. These 1891 patients were randomly assigned to faricimab every 8 weeks (YOSEMITE n=315, RHINE n=317), faricimab PTI (n=313, n=319), or aflibercept every 8 weeks (n=312, n=315). Non-inferiority for the primary endpoint was achieved with faricimab every 8 weeks (adjusted mean vs aflibercept every 8 weeks in YOSEMITE 10·7 ETDRS letters [97·52% CI 9·4 to 12·0] vs 10·9 ETDRS letters [9·6 to 12·2], difference -0·2 ETDRS letters [-2·0 to 1·6]; RHINE 11·8 ETDRS letters [10·6 to 13·0] vs 10·3 ETDRS letters [9·1 to 11·4] letters, difference 1·5 ETDRS letters [-0·1 to 3·2]) and faricimab PTI (YOSEMITE 11·6 ETDRS letters [10·3 to 12·9], difference 0·7 ETDRS letters [-1·1 to 2·5]; RHINE 10·8 ETDRS letters [9·6 to 11·9], difference 0·5 ETDRS letters [-1·1 to 2·1]). Incidence of ocular adverse events was comparable between faricimab every 8 weeks (YOSEMITE n=98 [31%], RHINE n=137 [43%]), faricimab PTI (n=106 [34%], n=119 [37%]), and aflibercept every 8 weeks (n=102 [33%], n=113 [36%]).Robust vision gains and anatomical improvements with faricimab were achieved with adjustable dosing up to every 16 weeks, demonstrating the potential for faricimab to extend the durability of treatment for patients with diabetic macular oedema.F Hoffmann-La Roche.
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- 2022
24. Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration A Phase 3 Randomized Clinical Trial
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Woo Se Joon, Bradvica Mario, Vajas Attila, Sagong Min, Ernest Jan, Studnicka Jan, Veith Miroslav, Wylegala Edward, Patel Sunil, Yun Cheolmin, Orski Michal, Astakhov Sergei, Tóth-Molnár Edit, and Csutak Adrienne
- Subjects
03.02. Klinikai orvostan - Published
- 2023
25. LASER VITREOLYSIS IN PATIENTS WITH SYMPTOMATIC VITREOUS FLOATERS
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Andrea Janeková, Miroslav Veith, Dana Fillová, and Michal Janek
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Adult ,Male ,Vitreous Body ,Ophthalmology ,Eye Diseases ,Vitrectomy ,Vision Disorders ,Humans ,Female ,Laser Therapy ,Lasers, Solid-State - Abstract
Aims: To examine the effectiveness and safety of Nd:YAG laser vitreolysis in patients with symptomatic vitreous floaters. Material and Methods: This was a single-centre study of adult patients with symptomatic vitreous floaters who underwent laser vitreolysis. Patients treated between 1/2020 and 10/2021 were included. Intraocular pressure was measured by non-contact tonometry before and one month after treatment. Colour fundus photography, slit lamp examination in mydriasis, best corrected visual acuity, optical coherence tomography, and ultrasound examinations were performed before treatment. The patients completed a questionnaire to subjectively rank the degree of impairment associated with the floaters before and between 1 and 2 months after treatment. Results: 89 eyes from 84 patients were included in the study, with a slight predominance of women (53%). A Weiss ring was present in 46%, and other types of vitreous opacity were found in 54%. Before treatment, 69% evaluated floaters as very troublesome (i.e., a value of 4 or 5 on a 1–5 scale). After treatment, 42% indicated subjective improvement (9% viewed the treatment as a complete success and 33% as a significant success). In 33% of eyes there was a partial improvement, i.e., some floaters could still be seen, and in 17% there was no improvement; 8% of patients were dissatisfied with the treatment results. There was no statistically significant difference in improvement between the group with Weiss rings and the group with other types of floaters. The procedure itself and the subsequent observation period were without complications, i.e., no cases of intraocular pressure elevation, cataract formation or retinal complications. Intraocular pressure did not significantly change from the pre-procedure value (p = 0.29). Average best corrected visual acuity after treatment was 0.97, thus it did not differ significantly from the pre-treatment values (p = 0.82). Conclusion: Nd:YAG laser vitreolysis subjectively improved floater-related symptoms in treated eyes. The lack of an objective measurement of treatment success is a limiting factor. Laser vitreolysis is more suitable for solitary than diffuse vitreous opacities.
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- 2022
26. Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes
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Attila Vajas, Hansol Jeong, Miroslav Veith, Neil M. Bressler, Jan Ernest, Inkyung Oh, Gabor Vogt, Mercy Yeeun Kim, András Papp, Veronika Matušková, Jan Hamouz, Dominik Zalewski, Donghoon Shin, James Luu, Taehyung Kim, Jan Studnička, Tamás Pregun, Young Hee Yoon, and Se Joon Woo
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medicine.medical_specialty ,Visual acuity ,business.industry ,Incidence (epidemiology) ,Macular degeneration ,medicine.disease ,Sensory Systems ,3. Good health ,Clinical trial ,03 medical and health sciences ,Cellular and Molecular Neuroscience ,Ophthalmology ,0302 clinical medicine ,Pharmacokinetics ,Internal medicine ,030221 ophthalmology & optometry ,Medicine ,Cumulative incidence ,030212 general & internal medicine ,medicine.symptom ,Ranibizumab ,business ,Adverse effect ,medicine.drug - Abstract
Background/AimsTo provide longer-term data on efficacy, safety, immunogenicity and pharmacokinetics (PK) of ranibizumab biosimilar SB11 compared with the reference ranibizumab (RBZ) in patients with neovascular age-related macular degeneration (nAMD).MethodsSetting: Multicentre.Design: Randomised, double-masked, parallel-group, phase III equivalence study.Patient population: ≥50 years old participants with nAMD (n=705), one ‘study eye’. Intervention: 1:1 randomisation to monthly intravitreal injection of 0.5 mg SB11 or RBZ.Main outcome measures: Visual efficacy endpoints, safety, immunogenicity and PK up to 52 weeks.ResultsBaseline and disease characteristics were comparable between treatment groups. Of 705 randomised participants (SB11: n=351; RBZ: n=354), 634 participants (89.9%; SB11: n=307; RBZ: n=327) completed the study until week 52. Previously reported equivalence in primary efficacy remained stable up to week 52 and were comparable between SB11 and RBZ. The adjusted treatment difference between SB11 and RBZ in full analysis set at week 52 of change from baseline in best-corrected visual acuity was −0.6 letters (90% CI −2.1 to 0.9) and of change from baseline in central subfield thickness was −14.9 µm (95% CI –25.3 to –4.5). The incidence of ocular treatment-emergent adverse events (TEAEs) (SB11: 32.0% vs RBZ: 29.7%) and serious ocular TEAE (SB11: 2.9% vs RBZ: 2.3%) appeared comparable between treatment groups, and no new safety concerns were observed. The PK and immunogenicity profiles were comparable, with a 4.2% and 5.5% cumulative incidence of antidrug antibodies up to week 52 for SB11 and RBZ, respectively.ConclusionsLonger-term results of this study further support the biosimilarity established between SB11 and RBZ.
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- 2021
27. Laser Vitreolysis in Patients with Symptomatic Vitreous Floaters
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Janeková, Andrea, primary, Veith, Miroslav, additional, Fillová, Dana, additional, and Janek, Michal, additional
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- 2022
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28. Incidence of adverse events after loading phase of the brolucizumab therapy of neovascular AMD: Real-life evidence in the Czech Republic
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Stepanov, Alexandr, primary, Studnicka, Jan, additional, Veith, Miroslav, additional, Nemec, Pavel, additional, Vyslouzilova, Daniela, additional, Koubek, Michal, additional, and Nemcansky, Jan, additional
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- 2022
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29. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials
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Heier, Jeffrey S, Lad, Eleonora M, Holz, Frank G, Rosenfeld, Philip J, Guymer, Robyn H, Boyer, David, Grossi, Federico, Baumal, Caroline R, Korobelnik, Jean-Francois, Slakter, Jason S, Waheed, Nadia K, Metlapally, Ravi, Pearce, Ian, Steinle, Nathan, Francone, Anibal A, Hu, Allen, Lally, David R, Deschatelets, Pascal, Francois, Cedric, Bliss, Caleb, Staurenghi, Giovanni, Monés, Jordi, Singh, Rishi P, Ribeiro, Ramiro, Wykoff, Charles C, Cole, Abosede O, Gerstenblith, Adam T, Kotagiri, Ajay, Edwards, Albert O, Zambrano, Alberto D, Eaton, Alexander M, Rubowitz, Alexander, Lyon, Alice T, Chiang, Allen, Ho, Allen, Hu, Allen Y, Guerami, Amir H, Dessouki, Amr L, de Carvalho, André Corrêa Maia, Emanuelli, Andrés, Chang, Andrew A, Antoszyk, Andrew N, Francone, Anibal Andrés, Prasad, Anita, Wolf, Armin, Khanani, Arshad M, Abbey, Ashkan Michael, Moulana, Asma, Wihelm, Barbara, Sikorski, Bartosz L, Kuppermann, Baruch D, Wolff, Benjamin, Jewart, Brian H, Do, Brian K, Chan-Kai, Brian T, Mein, Calvin, Hoyng, Carel B, Awh, Carl C, Regillio, Carl, Zeolite, Carlos, Baumal, Caroline R, Creuzot-Garcher, Catherine, Maury, Catherine Français, Wykoff, Charles C, Newell, Charles K, Jhaveri, Chirag, Lohmann, Chris P, Dinah, Christiana B, Ma, Colin, Crawford, Courtney, Parke, D Wilkin, Lavinsky, Daniel, Roth, Daniel, Pieramici, Dante J, Moshfeghi, Darius M, Levin, Darrin, Saperstein, David A, Brown, David, Gaucher, David, Lally, David R, Liao, David S, Brown, David Warren, Goldstein, Debra, Marcus, Dennis, Chan, Derek G, Dhoot, Dilsher, Tacite, Domingo, Zalewski, Dominik, Espana, Edgar M, Lad, Eleonora M, Souied, Eric H, Suan, Eric P, Eting, Eva, Sola, Federico Furno, de Bats, Flore, Bandello, Francesco, Gómez-Ulla, Francisco, Devin, François, Holz, Frank G, Chen, Fred K, Makkouk, Fuad, Dyer, Gawain, Spital, George, Staurenghi, Giovanni, Stoller, Glenn, Cousins, Gwen, Salehi-Had, Hani, Agostini, Hansjürgen, Eleftheriadis, Haralabos, Weiss, Harold, Sultan, Harris C, Massé, Hélène, Pearce, Ian, Dias, Indra, Barbazetto, Irene, Rosenblatt, Irit, Suñer, Ivan J, Kovach, Jaclyn L, Kaluzny, Jakub, Borthwick, James, Howard, James G, Wong, James, Ernest, Jan, Němčanský, Jan, Ysasaga, Jason Edward, Handza, Jason M, Moreno, Javier Antonio Montero, Korobelnik, Jean-François, Heier, Jeffrey S, Arnold, Jennifer J, Brown, Jeremiah, Bafalluy, Joaquin, Pearlman, Joel, Pitcher, John D, Kitchens, John, Carlson, John P, Gilhotra, Jolly, Fein, Jordana, Monés, Jordi M, Luna, José Domingo, Moreno, José María Ruiz, Coney, Joseph M, Sallum, Juliana Maria Ferraz, Olsen, Karl R, Blobner, Katharina, Macoul, Katherine A, Oh, Kean T, Malik, Khurram Javed, Hattenbach, Lars-Olof, Kodjikian, Laurent, Neto, Laurentino Biccas, Singerman, Lawrence J, Altay, Lebriz, Sheck, Leo-H, Feiner, Leonard, Harris, Lindsey D, Chishold, Lionel D, Rao, Llewelyn J, Nehemy, Márcio Bittar, Elizalde, Maria Jose Capella, Gamulescu, Maria-Andreea, Saravia, Mario J, Johnson, Mark W, McKibbin, Martin, Maccumber, Mathew, Vidosevich, Matko, Ohr, Matthew P, Samuel, Michael A, Singer, Michael A, Cassell, Michael, Dollin, Michael, Elman, Michael J, Ip, Michael S, Goldstein, Michaella, Busquets, Miguel, Mititelu, Mihai, Shah, Milan, Veith, Miroslav, Fineman, Mitchell, Varano, Monica, Christmas, Nancy, Steinle, Nathan C, Chaudhry, Nauman, Chinskey, Nicholas D, Eter, Nicole, London, Nikolas J S, Mathalone, Nurit, Schlottmann, Patricio G, Coady, Patrick, Higgins, Patrick M, Raskauskas, Paul A, Yates, Paul A, Bernstein, Paul, Mitchell, Paul, Monsour, Paul, Raphaelian, Paul V, Stanga, Paulo E, Stodulka, Pavel, Issa, Peter Charbel, Pavan, Peter, Ferrone, Phil J, Oleksy, Piotr, Abraham, Prema, Mruthyunjaya, Prithvi, Nguyen, Quan Dong, Reddy, Rahul K, Khurana, Rahul N, Tuli, Raman, Tadayoni, Ramin, Katz, Randy Steven, Arora, Rashi, Schlingemann, Reinier O, Rosen, Richard B, Gale, Richard, Scartozzi, Richard, Isernharge, Ricky, Singh, Rishi P, Stoltz, Robert A, Avery, Robert L, Wirthlin, Robert S, Guymer, Robyn, Goldberg, Roger A, Frenkel, Ronald, Belfort, Rubens Jr, Mohand-Said, Saddek, Grisanti, Salvatore, Razavi, Sam, Fraser-Bell, Samantha, Shah, Sandeep N, Wickremasinghe, Sanjeewa, Haug, Sara Joy, Adrean, Sean D, Priglinger, Siegfried G, Esposti, Simona Degli, Guest, Stephen, Huddleston, Stephen, Itty, Sujit, Moon, Suk Jin, Bhatia, Sumit P, Gupta, Sunil, Patel, Sunil S, Garg, Sunir J, Joshi, Sunir, Nghiem-Buffet, Sylvia, Johnson, T Mark, Jaouni, Tareq, Ach, Thomas, Williams, Thomas R, Sheidow, Thomas, Cleland, Timothy P, You, Timothy T, Peto, Tunde, Konidaris, Vasileios, Gonzalez, Victor H, Korda, Vladimir, Freeman, William R, Bridges, William Z, Barak, Yoreh, Zagorski, Zbigniew, Yehoshua, Zohar, and Dubska, Zora
- Abstract
Geographic atrophy is a leading cause of progressive, irreversible vision loss. The objectives of OAKS and DERBY were to assess the efficacy and safety of pegcetacoplan compared with sham treatment in patients with geographic atrophy.
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- 2023
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30. Early disruption of photoreceptor cell architecture and loss of vision in a humanized pig model of usher syndromes
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Grotz, Sophia, Schäfer, Jessica, Wunderlich, Kirsten A, Ellederova, Zdenka, Auch, Hannah, Bähr, Andrea, Runa‐Vochozkova, Petra; https://orcid.org/0000-0003-3691-0340, Fadl, Janet, Arnold, Vanessa, Ardan, Taras, Veith, Miroslav; https://orcid.org/0000-0001-6254-436X, Santamaria, Gianluca, Dhom, Georg, Hitzl, Wolfgang; https://orcid.org/0000-0002-7696-1479, Kessler, Barbara; https://orcid.org/0000-0001-7036-238X, Eckardt, Christian, Klein, Joshua, Brymova, Anna, Linnert, Joshua, Kurome, Mayuko, Zakharchenko, Valeri, Fischer, Andrea, Blutke, Andreas, Döring, Anna, Suchankova, Stepanka, Popelar, Jiri, Rodríguez‐Bocanegra, Eduardo, Dlugaiczyk, Julia; https://orcid.org/0000-0001-7693-9127, Straka, Hans, May‐Simera, Helen; https://orcid.org/0000-0002-9477-4036, et al, Grotz, Sophia, Schäfer, Jessica, Wunderlich, Kirsten A, Ellederova, Zdenka, Auch, Hannah, Bähr, Andrea, Runa‐Vochozkova, Petra; https://orcid.org/0000-0003-3691-0340, Fadl, Janet, Arnold, Vanessa, Ardan, Taras, Veith, Miroslav; https://orcid.org/0000-0001-6254-436X, Santamaria, Gianluca, Dhom, Georg, Hitzl, Wolfgang; https://orcid.org/0000-0002-7696-1479, Kessler, Barbara; https://orcid.org/0000-0001-7036-238X, Eckardt, Christian, Klein, Joshua, Brymova, Anna, Linnert, Joshua, Kurome, Mayuko, Zakharchenko, Valeri, Fischer, Andrea, Blutke, Andreas, Döring, Anna, Suchankova, Stepanka, Popelar, Jiri, Rodríguez‐Bocanegra, Eduardo, Dlugaiczyk, Julia; https://orcid.org/0000-0001-7693-9127, Straka, Hans, May‐Simera, Helen; https://orcid.org/0000-0002-9477-4036, and et al
- Abstract
Usher syndrome (USH) is the most common form of monogenic deaf-blindness. Loss of vision is untreatable and there are no suitable animal models for testing therapeutic strategies of the ocular constituent of USH, so far. By introducing a human mutation into the harmonin-encoding USH1C gene in pigs, we generated the first translational animal model for USH type 1 with characteristic hearing defect, vestibular dysfunction, and visual impairment. Changes in photoreceptor architecture, quantitative motion analysis, and electroretinography were characteristics of the reduced retinal virtue in USH1C pigs. Fibroblasts from USH1C pigs or USH1C patients showed significantly elongated primary cilia, confirming USH as a true and general ciliopathy. Primary cells also proved their capacity for assessing the therapeutic potential of CRISPR/Cas-mediated gene repair or gene therapy in vitro. AAV-based delivery of harmonin into the eye of USH1C pigs indicated therapeutic efficacy in vivo.
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- 2022
31. Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes.
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Bressler, Neil M., Veith, Miroslav, Hamouz, Jan, Ernest, Jan, Zalewski, Dominik, Studnička, Jan, Vajas, Attila, Papp, András, Vogt, Gabor, Luu, James, Matuskova, Veronika, Young Hee Yoon, Pregun, Tamás, Taehyung Kim, Donghoon Shin, Inkyung Oh, Hansol Jeong, Mercy Yeeun Kim, and Se Joon Woo
- Abstract
Background/Aims To provide longer-term data on efficacy, safety, immunogenicity and pharmacokinetics (PK) of ranibizumab biosimilar SB11 compared with the reference ranibizumab (RBZ) in patients with neovascular age-related macular degeneration (nAMD). Methods Setting: Multicentre. Design: Randomised, double-masked, parallel-group, phase III equivalence study. Patient population: ≥50 years old participants with nAMD (n=705), one 'study eye'. Intervention: 1:1 randomisation to monthly intravitreal injection of 0.5 mg SB11 or RBZ. Main outcome measures: Visual efficacy endpoints, safety, immunogenicity and PK up to 52 weeks. Results Baseline and disease characteristics were comparable between treatment groups. Of 705 randomised participants (SB11: n=351; RBZ: n=354), 634 participants (89.9%; SB11: n=307; RBZ: n=327) completed the study until week 52. Previously reported equivalence in primary efficacy remained stable up to week 52 and were comparable between SB11 and RBZ. The adjusted treatment difference between SB11 and RBZ in full analysis set at week 52 of change from baseline in best-corrected visual acuity was -0.6 letters (90% CI -2.1 to 0.9) and of change from baseline in central subfield thickness was -14.9 µm (95% CI -25.3 to -4.5). The incidence of ocular treatment-emergent adverse events (TEAEs) (SB11: 32.0% vs RBZ: 29.7%) and serious ocular TEAE (SB11: 2.9% vs RBZ: 2.3%) appeared comparable between treatment groups, and no new safety concerns were observed. The PK and immunogenicity profiles were comparable, with a 4.2% and 5.5% cumulative incidence of antidrug antibodies up to week 52 for SB11 and RBZ, respectively. Conclusions Longer-term results of this study further support the biosimilarity established between SB11 and RBZ. [ABSTRACT FROM AUTHOR]
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- 2023
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32. Incidence of adverse events after loading phase of the brolucizumab therapy of neovascular AMD: Real-life evidence in the Czech Republic.
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Stepanov, Alexandr, Studnicka, Jan, Veith, Miroslav, Nemec, Pavel, Vyslouzilova, Daniela, Koubek, Michal, and Nemcansky, Jan
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- 2023
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33. Effect of baseline central retinal thickness on the results of treatment of diabetic macular edema with aflibercept: Real-Life Evidence in the Czech Republic
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Němčanský, Jan, primary, Stěpanov, Alexandr, additional, Veith, Miroslav, additional, Koubek, Michal, additional, Kopecký, Adam, additional, Němčanská, Sabina, additional, Beran, David, additional, and Studnička, Jan, additional
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- 2022
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34. Intravitreal Ranibizumab in Pregnant Patient with Myopic Choroidal Neovascular Membrane. A Case Report
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Penčák, Martin, primary and Veith, Miroslav, additional
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- 2022
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35. Early disruption of photoreceptor cell architecture and loss of vision in a humanized pig model of usher syndromes
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Grotz, Sophia, primary, Schäfer, Jessica, additional, Wunderlich, Kirsten A, additional, Ellederova, Zdenka, additional, Auch, Hannah, additional, Bähr, Andrea, additional, Runa‐Vochozkova, Petra, additional, Fadl, Janet, additional, Arnold, Vanessa, additional, Ardan, Taras, additional, Veith, Miroslav, additional, Santamaria, Gianluca, additional, Dhom, Georg, additional, Hitzl, Wolfgang, additional, Kessler, Barbara, additional, Eckardt, Christian, additional, Klein, Joshua, additional, Brymova, Anna, additional, Linnert, Joshua, additional, Kurome, Mayuko, additional, Zakharchenko, Valeri, additional, Fischer, Andrea, additional, Blutke, Andreas, additional, Döring, Anna, additional, Suchankova, Stepanka, additional, Popelar, Jiri, additional, Rodríguez‐Bocanegra, Eduardo, additional, Dlugaiczyk, Julia, additional, Straka, Hans, additional, May‐Simera, Helen, additional, Wang, Weiwei, additional, Laugwitz, Karl‐Ludwig, additional, Vandenberghe, Luk H, additional, Wolf, Eckhard, additional, Nagel‐Wolfrum, Kerstin, additional, Peters, Tobias, additional, Motlik, Jan, additional, Fischer, M Dominik, additional, Wolfrum, Uwe, additional, and Klymiuk, Nikolai, additional
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- 2022
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36. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials
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Wykoff, Charles C, primary, Abreu, Francis, additional, Adamis, Anthony P, additional, Basu, Karen, additional, Eichenbaum, David A, additional, Haskova, Zdenka, additional, Lin, Hugh, additional, Loewenstein, Anat, additional, Mohan, Shaun, additional, Pearce, Ian A, additional, Sakamoto, Taiji, additional, Schlottmann, Patricio G, additional, Silverman, David, additional, Sun, Jennifer K, additional, Wells, John A, additional, Willis, Jeffrey R, additional, Tadayoni, Ramin, additional, Aaberg, Thomas, additional, Abbey, Ashkan, additional, Abdulaeva, Elmira, additional, Abengoechea, Santiago, additional, Abraham, Prema, additional, Ach, Thomas, additional, Adams, Serrhel, additional, Adan Civera, Alfredo, additional, Adrean, Sean, additional, Agostini, Hansjurgen, additional, Alam, Suhail, additional, Alezzandrini, Arturo, additional, Alfaro, Virgil, additional, Aliseda, Daniel, additional, Almony, Arghavan, additional, Amat, Pedro, additional, Amini, Payam, additional, Antoszyk, Andrew, additional, Arias, Luis, additional, Asaria, Riaz, additional, Avila, Marcos, additional, Awh, Carl C, additional, Bafalluy, Joaquin, additional, Baker, Carl, additional, Bandello, Francesco, additional, Barakat, Mark, additional, Barraza, Karen, additional, Bator, Gyorgy, additional, Baumal, Caroline, additional, Belfort Jr, Rubens, additional, Bergstrom, Chris, additional, Bertolucci, George, additional, Bochow, Thomas, additional, Bolz, Matthias, additional, Borcz, Emilia, additional, Bordon, Arnaldo, additional, Boyer, David, additional, Bratko, Galina, additional, Brent, Michael, additional, Brown, Jamin, additional, Brown, David M, additional, Budzinskaya, Maria, additional, Buffet, Sylvia, additional, Burgess, Stuart, additional, Burton, Ben, additional, Busquets, Miguel, additional, Cabrera, Francisco, additional, Cagini, Carlo, additional, Calzada, Jorge, additional, Campochiaro, Peter, additional, Carlson, John, additional, Castellarin, Alessandro, additional, Cava, Carlos, additional, Chaikitmongkol, Voraporn, additional, Chan, Clement, additional, Chang, Emmanuel, additional, Chang, Jonathan, additional, Chang, Andrew, additional, Charles, Steve, additional, Chaudhry, Nauman, additional, Chee, Caroline, additional, Chen, Judy, additional, Chen, Fred, additional, Chen, Shih-Jen, additional, Cheong-Leen, Richard, additional, Chiang, Allen, additional, Chittum, Mark, additional, Chow, David, additional, Connolly, Brian, additional, Cornut, Pierre Loic, additional, Csaky, Karl, additional, Danzig, Carl, additional, Das, Arup, additional, Daskalov, Vesselin, additional, Desco, Carmen, additional, Dessouki, Amr, additional, Dickinson, John, additional, Do, Brian, additional, Dollin, Michael, additional, Dugel, Pravin, additional, Dusova, Jaroslava, additional, Eichenbaum, David, additional, Eldem, Bora, additional, Engstrom, Robert, additional, Ernest, Jan, additional, Escobar, Joan Josep, additional, Esposti, Simona, additional, Eter, Nicole, additional, Falk, Naomi, additional, Farkas, Andrej, additional, Feiner, Leonard, additional, Feltgen, Nicolas, additional, Fernandez, Carlos, additional, Fernandez Vega, Alvaro, additional, Ferrone, Philip, additional, Figueira, Joao, additional, Figueroa, Marta, additional, Findl, .Oliver, additional, Fine, Howard, additional, Fortun, Jorge, additional, Fox, Gregory M, additional, Foxman, Scott, additional, Framme, Carsten, additional, Fraser-Bell, Samantha, additional, Fu, Arthur, additional, Fukutomi, Akira, additional, Fung, Nicholas, additional, Furno Sola, Federico, additional, Gallego-Pinazo, Roberto, additional, Garcia, Renata, additional, Garcia-Layana, Alfredo, additional, Gawecki, Maciej, additional, George, Sheen, additional, Ghanchi, Faruque, additional, Ghorayeb, Ghassan, additional, Goldberg, Roger, additional, Goldstein, Michaella, additional, Gomes, Nuno, additional, Gomez Ulla, Francisco, additional, Gonzalez, Victor, additional, Greven, Craig, additional, Gupta, Sunil, additional, Guzman, Miguel, additional, Harris, Martin, additional, Hatz, Katja, additional, Hau, Vivienne, additional, Hau, Vincent, additional, Hayashi, Ken, additional, Heier, Jeffrey, additional, Herba, Ewa, additional, Hershberger, Vrinda, additional, Higgins, Patrick, additional, Hirakata, Akito, additional, Ho, Allen, additional, Holekamp, Nancy, additional, Honda, Shigeru, additional, Hsu, Jason, additional, Hu, Allen, additional, Hurcikova, Maria, additional, Ikeda, Yasuhiro, additional, Isernhagen, Ricky, additional, Ito, Yasuki, additional, Jackson, Tim, additional, Jacoby, Rachael, additional, Jafree, Afsar, additional, Javey, Golnaz, additional, Javid, Cameron, additional, Jhaveri, Chirag, additional, Johnson, Mark, additional, Kacerík, Marek, additional, Kaluzny, Jakub, additional, Kampik, Daniel, additional, Kang, Se Woong, additional, Kapoor, Kapil, additional, Karabas, Levent, additional, Kawasaki, Tsutomu, additional, Kerenyi, Agnes, additional, Khanani, Arshad, additional, Khurana, Rahul, additional, Kim, Brian, additional, Kimura, Kazuhiro, additional, Kishino, Genichiro, additional, Kitano, Shigehiko, additional, Klein-Mascia, Kendra, additional, Kokame, Gregg, additional, Korobelnik, Jean Francois, additional, Kulikov, Alexey, additional, Kuriyan, Ajay, additional, Kwong, Henry, additional, Kwun, Robert, additional, Lai, Timothy, additional, Lai, Chi-Chun, additional, Laird, Philip, additional, Lalonde, Laurent, additional, Lanzetta, Paolo, additional, Larsen, Michael, additional, Laugesen, Caroline, additional, Lavinsky, Daniel, additional, Lebreton, Olivier, additional, Lee, Seong, additional, Levy, Jaime, additional, Lipkova, Blandina, additional, Liu, Mimi, additional, Liu, Judy, additional, Lohmann, Chris P, additional, London, Nikolas, additional, Lorenz, Katrin, additional, Lotery, Andrew, additional, Lozano Rechy, David, additional, Lujan, Silvio, additional, Ma, Patrick, additional, Maeno, Takatoshi, additional, Mahmood, Sajjad, additional, Makkouk, Fuad, additional, Malik, Khurram, additional, Marcus, Dennis, additional, Margherio, Alan, additional, Mastropasqua, Leonardo, additional, Maturi, Raj, additional, McCabe, Frank, additional, McKibbin, Martin, additional, Mehta, Hemal, additional, Menon, Geeta, additional, Mentes, Jale, additional, Michalska-Malecka, Katarzyna, additional, Misheva, Aneta, additional, Mitamura, Yoshinori, additional, Mitchell, Paul, additional, Modi, Yasha, additional, Mohamed, Quresh, additional, Montero, Javier, additional, Moore, Jeffrey, additional, Morales Canton, Virgilio, additional, Morori-Katz, Haia, additional, Morugova, Tatiana, additional, Murakami, Tomoaki, additional, Muzyka-Wozniak, Maria, additional, Nardi, Marco, additional, Nemcansky, Jan, additional, Nester-Ostrowska, Kamila, additional, Neto, Julio, additional, Newell, Charles, additional, Nicolo, Massimo, additional, Nielsen, Jared, additional, Noda, Kousuke, additional, Obana, Akira, additional, Ogata, Nahoko, additional, Oh, Hideyasu, additional, Oh, Kean, additional, Ohr, Matthew, additional, Oleksy, Piotr, additional, Oliver, Scott, additional, Olivier, Sebastien, additional, Osher, James, additional, Ozcalişkan, Sehnaz, additional, Ozturk, Banu, additional, Papp, Andras, additional, Park, Kyu Hyung, additional, Parke, D Wilkin, additional, Parravano, Maria Cristina, additional, Patel, Sugat, additional, Patel, Sunil, additional, Pearce, Ian, additional, Pearlman, Joel, additional, Penha, Fernando, additional, Perente, Irfan, additional, Perkins, Stephen, additional, Pertile, Grazia, additional, Petkova, Iva, additional, Peto, Tunde, additional, Pieramici, Dante, additional, Pollreisz, Andreas, additional, Pongsachareonnont, Pear, additional, Pozdeyeva, Nadezhda, additional, Priglinger, Siegfried, additional, Qureshi, Jawad, additional, Raczynska, Dorota, additional, Rajagopalan, Rajesh, additional, Ramirez Estudillo, Juan, additional, Raskauskas, Paul, additional, Rathod, Rajiv, additional, Razavi, Hessam, additional, Regillo, Carl, additional, Ricci, Federico, additional, Rofagha, Soraya, additional, Romanczak, Dominika, additional, Romanowska-Dixon, Bożena, additional, Rosberger, Daniel, additional, Rosenblatt, Irit, additional, Rosenblatt, Brett, additional, Ross, Adam, additional, Ruamviboonsuk, Paisan, additional, Ruiz Moreno, Jose Maria, additional, Salomão, Gustavo, additional, Sandhu, Sukhpal, additional, Sandner, Dirk, additional, Sararols, Laura, additional, Sawada, Osamu, additional, Schadlu, Ramin, additional, Schlottmann, Patricio, additional, Schuart, Claudia, additional, Seitz, Berthold, additional, Seres, András, additional, Sermet, Figen, additional, Shah, Sandeep, additional, Shah, Ankur, additional, Shah, Rohan, additional, Sharma, Sumit, additional, Sheidow, Thomas, additional, Sheth, Veeral, additional, Shimouchi, Akito, additional, Shimura, Masahiko, additional, Sikorski, Bartosz, additional, Silva, Rufino, additional, Singer, Michael, additional, Singerman, Lawrence, additional, Singh, Rishi, additional, Souied, Eric, additional, Spinak, David J, additional, Spital, Georg, additional, Steinle, Nathan, additional, Stern, Jeffrey, additional, Stoller, Glenn, additional, Stoltz, Robert, additional, Stone, Cameron, additional, Stone, Amy, additional, Suan, Eric, additional, Sugimoto, Masahiko, additional, Sugita, Iichiro, additional, Sun, Jennifer, additional, Sun, Xiaodong, additional, Suner, Ivan, additional, Szalczer, Lajos, additional, Szecsko, Timea, additional, Tabassian, Ali, additional, Takagi, Hitoshi, additional, Takayama, Kei, additional, Taleb, Alexandre, additional, Talks, James, additional, Tan, Gavin, additional, Tanabe, Teruyo, additional, Taylor, Stanford, additional, Thach, Allen, additional, Thompson, John, additional, Tlucek, Paul, additional, Torti, Robert, additional, Tosheva Guneva, Daniela, additional, Toth-Molnar, Edit, additional, Uchiyama, Eduardo, additional, Vajas, Attila, additional, Varma, Deepali, additional, Varsanyi, Balazs, additional, Vassileva, Petja, additional, Vaz-Pereira, Sara, additional, Veith, Miroslav, additional, Vela, Jose Ignacio, additional, Viola, Francesco, additional, Virgili, Gianni, additional, Vogt, Gábor, additional, Vorum, Henrik, additional, Weber, Pamela, additional, Wecke, Thoalf, additional, Wee, Raymond, additional, Weger, Martin, additional, Weishaar, Paul, additional, Wickremasinghe, Sanjeewa, additional, Williams, Thomas Reginald, additional, Williams, Thomas, additional, Williams, Geoff, additional, Wolf, Armin, additional, Wolfe, Jeremy, additional, Wong, James, additional, Wong, David, additional, Wong, Ian, additional, Wong, Robert, additional, Wowra, Bogumil, additional, Wykoff, Charles C, additional, Wylęgała, Edward, additional, Yang, Chang-Hao, additional, Yasukawa, Tsutomu, additional, Yates, Paul, additional, Yilmaz, Gursel, additional, Yiu, Glenn, additional, Yoon, Young Hee, additional, Yoreh, Barak, additional, Yoshida, Shigeo, additional, Yu, Hyeong Gon, additional, Yu, Seung Young, additional, Yurieva, Tatiana, additional, Zacharias, Leandro, additional, Zaczek Zakrzewska, Karolina, additional, Zambrano, Alberto, additional, Zatorska, Barbara, additional, Zeolite, Carlos, additional, and Zheutlin, Jeffrey, additional
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- 2022
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37. ARTEFICIAL INTELLIGENCE IN DIABETIC RETINOPATHY SCREENING. A REVIEW
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Zbyněk Straňák, Miroslav Veith, and M Penčák
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Diabetic Retinopathy ,business.industry ,Diabetic retinopathy screening ,Intelligence ,Gold standard (test) ,Diabetic retinopathy ,Eye care ,medicine.disease ,Clinical Practice ,Ophthalmology ,Artificial Intelligence ,Diabetes Mellitus ,Medicine ,Deep neural networks ,Humans ,Mass Screening ,Artificial intelligence ,business ,Mass screening ,Algorithms - Abstract
Objective: The aim of this comprehensive paper is to acquaint the readers with evaluation of the retinal images using the arteficial intelligence (AI). Main focus of the paper is diabetic retinophaty (DR) screening. The basic principles of the artificial intelligence and algorithms that are already used in clinical practice or are shortly before approval will be described. Methodology: Describing the basic characteristics and mechanisms of different approaches to the use of AI and subsequently literary minireview clarifying the current state of knowledge in the area. Results: Modern systems for screening diabetic retinopathy using deep neural networks achieve a sensitivity and specificity of over 80 % in most published studies. The results of specific studies vary depending on the definition of the gold standard, number of images tested and on the evaluated parameters. Conclusion: Evaluation of images using AI will speed up and streamline the diagnosis of DR. The use of AI will allow to keep the quality of the eye care at least on the same level despite the raising number of the patients with diabetes.
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- 2021
38. UVEAL EFFUSION SYNDROME. CASE REPORT
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M Penčák, Miroslav Veith, P Studený, and A Konrád
- Subjects
medicine.medical_specialty ,Intraocular pressure ,business.industry ,medicine.medical_treatment ,Ultrasound biomicroscopy ,Retinal Detachment ,Retinal detachment ,Perioperative ,Choroid Diseases ,Exudates and Transudates ,Uveal Effusion Syndrome ,Cataract surgery ,Uvea ,medicine.disease ,Sclera ,Ophthalmology ,medicine.anatomical_structure ,medicine ,Humans ,Choroid ,business ,Aged - Abstract
Purpose: Purpose of this article is to present a case report of a patient with uveal effusion syndrome who underwent deep posterior sclerotomy. Case report: A 73-year-old patient with unilateral decrease in the best corrected visual acuity, ablation of choroid and secondary retinal detachment in the right eye was admitted to our clinic for examination in November 2017. At the first examination, the best corrected visual acuity in the right eye was 0.3, in the left eye 1.0. Intraocular pressure was 16 mmHg in the right eye and 21 mmHg in the left eye. After performing ultrasound biomicroscopy of the anterior segment (Accutome, Keeler, USA), ultrasound sonography of the affected eye (Accutome, Keeler, USA), magnetic resonance imaging, computed tomography, abdominal ultrasound and blood tests, we concluded the finding as uveal effusion syndrome. We initiated a conservative treatment consisting of oral administration of carbonic anhydrase inhibitor in combination with topical use of prostaglandin analogue. Despite conservative treatment the best corrected visual acuity of the affected eye decreased to 0.05 so we proceeded to a surgical procedure – deep posterior sclerotomy with perioperative scleral sampling for histological examination (detection of glycosaminoglycans in the sclera wall by Alcian blue staining), which was negative. This histological result ranks the patient as the third type of uveal effusion syndrome (ie, non-nanophthalmic with a normal sclera). After the operation both the ablation of choroid and retinal detachment reattached and the best corrected visual acuity in the right eye improved to 0.3. After the subsequent cataract surgery, the ablation of choroid and retinal detachment occurred again, this time with spontaneous recovery. Postoperatively, the best corrected visual acuity in the right eye was 0.5 and at the last check-up at our clinic 0.6. Conclusion: Deep posterior sclerotomy is a method of choice of surgical treatment for uveal effusion syndrome that does not respond to conservative therapy.
- Published
- 2021
39. Letter to the Editor from Brunerová et al: 'Association of Cognitive Function and Retinal Neural and Vascular Structure in Type 1 Diabetes'
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Miroslav Veith, Pavel Škrha, Ludmila Brunerová, Richard Sotorník, Elena Šilhová, Jaroslava Raudenská, Adam Ernest, and Alena Javůrková
- Subjects
Type 1 diabetes ,medicine.medical_specialty ,Letter to the editor ,business.industry ,Endocrinology, Diabetes and Metabolism ,Association (object-oriented programming) ,Biochemistry (medical) ,Clinical Biochemistry ,MEDLINE ,Retinal ,Cognition ,Bioinformatics ,medicine.disease ,Biochemistry ,chemistry.chemical_compound ,Endocrinology ,chemistry ,Internal medicine ,medicine ,Vascular structure ,business - Published
- 2021
40. Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes
- Author
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Bressler, Neil M, primary, Veith, Miroslav, additional, Hamouz, Jan, additional, Ernest, Jan, additional, Zalewski, Dominik, additional, Studnička, Jan, additional, Vajas, Attila, additional, Papp, András, additional, Vogt, Gabor, additional, Luu, James, additional, Matuskova, Veronika, additional, Yoon, Young Hee, additional, Pregun, Tamás, additional, Kim, Taehyung, additional, Shin, Donghoon, additional, Oh, Inkyung, additional, Jeong, Hansol, additional, Kim, Mercy Yeeun, additional, and Woo, Se Joon, additional
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- 2021
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41. Uveal Effusion Syndrome. Case Report
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Konrád, Aleš, primary, Penčák, Martin, additional, Veith, Miroslav, additional, and Studený, Pavel, additional
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- 2021
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42. The Burden of Macular Diseases in Central and Eastern Europe—Implications for Healthcare Systems
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Zoltán Zsolt Nagy, Iva Petkova, Polona Jaki Mekjavic, Zuzana Jamrichova, Miroslav Veith, Sławomir Teper, Lala Ćeklić, Vilma Jūratė Balčiūnienė, Jan Ernest, and Ivana Gardašević Topčić
- Subjects
medicine.medical_specialty ,genetic structures ,Status quo ,media_common.quotation_subject ,Economics, Econometrics and Finance (miscellaneous) ,Guidelines as Topic ,Macular Edema ,Reimbursement Mechanisms ,03 medical and health sciences ,Indirect costs ,0302 clinical medicine ,Cost of Illness ,Retinal Diseases ,Health care ,Epidemiology ,medicine ,Humans ,030212 general & internal medicine ,Pharmacology, Toxicology and Pharmaceutics (miscellaneous) ,Health policy ,Reimbursement ,media_common ,Government ,business.industry ,030503 health policy & services ,Health Policy ,Macular degeneration ,medicine.disease ,eye diseases ,Europe ,Family medicine ,Wet Macular Degeneration ,0305 other medical science ,business ,Delivery of Health Care - Abstract
Background Despite the significant impact of retinal diseases such as wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), there is a limited understanding of how these conditions are managed in Central and Eastern Europe (CEE). Objectives To provide a comprehensive overview of the clinical and economic burden of wAMD and DME in CEE and the status quo associated with their management. Methods A narrative literature review was undertaken to identify existing data on wAMD and DME, including epidemiology, economic burden, clinical guidelines, and available and reimbursed treatments. Data were collected from relevant sources such as PubMed, ophthalmology associations, national statistical offices, and government agency websites; practical viewpoints were provided by local ophthalmologists and healthcare economics experts in CEE. Results Epidemiological data on wAMD and DME are limited in CEE, and intercountry comparison is difficult because of differences in data collection methodologies. There are effective treatment options for wAMD and DME, and international guidelines advocate the use of intravitreal anti-vascular endothelial growth factor injections as first-line therapy. Local expert organizations broadly support these recommendations; nevertheless, no clinical practice guidelines exist on the treatment of wAMD and DME in CEE. Access to and reimbursement of anti-vascular endothelial growth factor agents vary significantly in the region and, as a result, many patients remain untreated or inadequately treated. Conclusions There is an urgent need for the creation of a wAMD/DME treatment program in CEE to ensure that patients have timely access to the most appropriate treatments.
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- 2019
43. Response to Aflibercept Therapy in Three Types of Choroidal Neovascular Membrane in Neovascular Age-Related Macular Degeneration: Real-Life Evidence in the Czech Republic
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Miroslav Veith, Michal Koubek, Alexandr Stepanov, Yun Min Klimesova, Jan Nemcansky, and Jan Studnička
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0301 basic medicine ,medicine.medical_specialty ,Visual acuity ,Article Subject ,genetic structures ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,lcsh:Ophthalmology ,Ophthalmology ,medicine ,Aflibercept ,business.industry ,Retinal ,Diabetic retinopathy ,Consecutive case series ,Macular degeneration ,medicine.disease ,eye diseases ,Regimen ,030104 developmental biology ,chemistry ,lcsh:RE1-994 ,Cohort ,030221 ophthalmology & optometry ,sense organs ,medicine.symptom ,business ,Research Article ,medicine.drug - Abstract
Purpose. To present a cohort of treatment-naive patients with the neovascular form of age-related macular degeneration (nAMD) treated with aflibercept in a fixed regimen and evaluate the treatment response of three types of choroidal neovascular membrane (CNV)—occult (Type 1), classic (Type 2), and minimally classic (Type 4). Methods. This was a multicentre, prospective, observational consecutive case series study. Patients diagnosed with three types of CNV of nAMD were treated in a fixed regimen (3 injections every 4 weeks, and then injections at 8 week intervals). The follow-up period was 48 weeks. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and spectral-domain optical coherence tomography (OCT). The measurements were taken at the baseline and then at 16, 32, and 48 weeks. Results. The treatment-naive group was composed of 135 eyes of 135 patients in the study. 61 eyes had Type 1 lesions of CNV, 50 eyes had Type 2 lesions, and 24 eyes had Type 4 lesions. Mean baseline BCVA ± SD for Type 1 lesions was 56.1 ± 10.8 ETDRS letters, and then 62.2 ± 12.9 letters, 61.2 ± 13.7 letters, and 62.8 ± 15.1 letters at 16, 32, and 48 weeks, respectively. Mean baseline CRT ± SD for Type 1 lesions was 442.4 ± 194.9 μm, and then 302.5 ± 144.4 μm, 299.7 ± 128.5 μm, and 277.7 ± 106.5 μm at 16, 32, and 48 weeks, respectively. Mean baseline BCVA ± SD for Type 2 lesions was 55.6 ± 9.9 ETDRS letters, and then 62.5 ± 11.1 letters, 60.7 ± 13.0 letters, and 62.5 ± 14.2 letters at 16, 32, and 48 weeks, respectively. Mean baseline CRT ± SD. For Type 4 lesions mean baseline BCVA ± SD was 56.7 ± 9.0 ETDRS letters, and then 59.1 ± 10.6 letters, 59.5 ± 11.4 letters, and 59.2 ± 12.6 letters at 16, 32, and 48 weeks respectively. Mean baseline CRT ± SD for Type 4 lesions was 492.1 ± 187.0 μm, and then 333.3 ± 137.5 μm, 354.4 ± 175.0 μm, and 326.7 ± 122.4 μm at 16, 32, and 48 weeks respectively. All these changes were statistically significant (p<0.005). Conclusions. The primary outcome of our study is that the treatment with aflibercept in nAMD patients led to statistically significant improvement in BCVA and to a decrease in CRT throughout the follow-up period in both occult and classic types of CNV. The minimally classic type of CNV demonstrated a poorer functional and anatomical response to treatment.
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- 2019
44. 25-gauge vitrectomy and gas for the management of rhegmatogenous retinal detachment
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M Penčák, Miroslav Veith, Pavel Studeny, Stranák Z, and Jana Vranova
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Adult ,Male ,Pars plana ,25-gauge ,Intraocular pressure ,medicine.medical_specialty ,genetic structures ,medicine.medical_treatment ,Visual Acuity ,lcsh:Medicine ,Vitrectomy ,030204 cardiovascular system & hematology ,oblique ,transconjunctival ,General Biochemistry, Genetics and Molecular Biology ,03 medical and health sciences ,chemistry.chemical_compound ,Postoperative Complications ,0302 clinical medicine ,gas ,Ophthalmology ,Humans ,Medicine ,General anaesthesia ,Intraocular Pressure ,Aged ,Retrospective Studies ,Aged, 80 and over ,business.industry ,Incidence (epidemiology) ,lcsh:R ,Retinal Detachment ,Retinal detachment ,Retinal ,Middle Aged ,medicine.disease ,rhegmatogenous ,eye diseases ,Treatment Outcome ,medicine.anatomical_structure ,chemistry ,030220 oncology & carcinogenesis ,Female ,sense organs ,Tamponade ,business ,Follow-Up Studies - Abstract
Aims: To evaluate the anatomical and functional results in patients with rhegmatogenous retinal detachment (RRD) who underwent 25-gauge pars plana vitrectomy (PPV) with gas tamponade. Materials and Methods: A retrospective evaluation of 126 eyes of 126 patients (79 men, 47 women) with RRD who underwent 25-gauge PPV with gas tamponade (13% C3F8 in 87 eyes, 20% SF6 in 39 eyes). 113 patients (89.7%), were operated on under local anaesthesia, 13 patients (10.3%) under general anaesthesia. Macula was detached in 85 eyes (67.5%). 53 eyes had pseudophakic RRD, 73 eyes were phakic. Anatomical success of the primary intervention, change in best corrected visual acuity (BCVA) and incidence of complications were assessed. An average follow-up period is 7.2 months (6-15). Results: With single operation, retinal attachment was achieved in 125 eyes (99.2%); the final anatomical success was 100%. The initial mean BCVA was 0.89 logMar (2.00 to 0.00); at the end of the follow-up period, it improved to 0.23logMAR (1.00 to -0.10), P < 0,0001. During the first post-intervention day, hypotony of the eye below 10 mmHg was observed in 1 patient (0.8%); on the contrary, intraocular pressure was temporarily increased to 25 mmHg and more in 36 patients (28.6%). Conclusion: The surgical treatment of RRD using 25-gauge PPV with expansive gas tamponade renders excellent anatomical results and improvement in BCVA. The incidence of complications and necessity of sclerotomy suturing are low.
- Published
- 2019
45. Early Disruption of Photoreceptor Cell Architecture and Loss of Vision in a Humanized Pig Model of Usher Syndrome
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Grotz, Sophia, primary, Schäfer, Jessica, additional, Wunderlich, Kirsten A., additional, Ellederova, Zdenka, additional, Auch, Hannah, additional, Bähr, Andrea, additional, Runa-Vochozkova, Petra, additional, Plutniok, Janet, additional, Arnold, Vanessa, additional, Ardan, Taras, additional, Veith, Miroslav, additional, Santamaria, Gianluca, additional, Dhom, Georg, additional, Hitzl, Wolfgang, additional, Kessler, Barbara, additional, Kurome, Mayuko, additional, Zakharchenko, Valeri, additional, Linnert, Joshua, additional, Fischer, Andrea, additional, Blutke, Andreas, additional, Döring, Anna, additional, Suchankova, Stepanka, additional, Popelar, Jiri, additional, May-Simera, Helen, additional, Laugwitz, Karl-Ludwig, additional, Vandenberghe, Luk H., additional, Wolf, Eckhard, additional, Nagel-Wolfrum, Kerstin, additional, Motlik, Jan, additional, Fischer, M. Dominik, additional, Wolfrum, Uwe, additional, and Klymiuk, Nikolai, additional
- Published
- 2021
- Full Text
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46. Letter to the Editor from Brunerová et al: “Association of Cognitive Function and Retinal Neural and Vascular Structure in Type 1 Diabetes”
- Author
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Brunerová, Ludmila, primary, Raudenská, Jaroslava, additional, Sotorník, Richard, additional, Šilhová, Elena, additional, Škrha, Pavel, additional, Veith, Miroslav, additional, Ernest, Adam, additional, and Javůrková, Alena, additional
- Published
- 2021
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47. Asymmetric response to ranibizumab in mixed choroidal neovascularization in a neovascular age-related macular degeneration diagnosed on OCT angiography – case report
- Author
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M Penčák and Miroslav Veith
- Subjects
Male ,medicine.medical_specialty ,Visual acuity ,genetic structures ,Resistance ,Visual Acuity ,Angiogenesis Inhibitors ,Lesion ,Macular Degeneration ,lcsh:Ophthalmology ,Ranibizumab ,Ophthalmology ,Case report ,Humans ,Medicine ,Fluorescein Angiography ,Macular edema ,Age‐related macular degeneration ,Aflibercept ,business.industry ,Anti-VEGF ,Angiography ,Mixed CNV ,General Medicine ,Diabetic retinopathy ,Middle Aged ,Macular degeneration ,medicine.disease ,Choroidal Neovascularization ,eye diseases ,Treatment Outcome ,Choroidal neovascularization ,lcsh:RE1-994 ,Intravitreal Injections ,sense organs ,medicine.symptom ,business ,Tomography, Optical Coherence ,medicine.drug - Abstract
Background To present a case report of a patient with a mixed choroidal neovascular membrane (CNV) with an asymmetric response to ranibizumab diagnosed on optical coherence tomography angiography (OCTa). Case presentation A 61-year-old male was referred to our department in September 2017 due to decreased vision in his left eye. Best-corrected visual acuity (BCVA) was 43 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the left eye. Macular edema was present in the left eye, and a mixed CNV was identified on the OCTa. Therapy with intravitreal ranibizumab was commenced. After 5 ranibizumab injections, the BCVA was 42 ETDRS letters, and considerable intraretinal edema was still present. OCTa showed a resolution of the type 2 lesion of the mixed CNV; however, the type 1 lesion had continued to grow. The patient was then switched to intravitreal aflibercept. After 3 monthly aflibercept injections, the BCVA improved to 53 ETDRS letters, and a reduction of the edema was observed on the optical coherence tomography (OCT). OCTa showed a decrease in both the area and vessel density in the type 1 lesion of the CNV. Therapy with aflibercept was continued; however, while the intraretinal edema continued to improve, atrophy developed in the macula and the BCVA worsened to 43 ETDRS letters. Conclusions Ranibizumab nonresponse in a neovascular age-related macular degeneration is not uncommon. However, to our knowledge, this is the first described case of an asymmetric response to ranibizumab in a mixed CNV. While the type 2 lesion of the CNV reacted swiftly to the ranibizumab therapy, the type 1 lesion continued to grow. As with some other cases of ranibizumab resistance, switching to aflibercept proved effective.
- Published
- 2021
48. Long-term Results of a Combined Procedure of Cataract Surgery and Descemet Membrane Endothelial Keratoplasty With Stromal Rim
- Author
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Universidad de Alicante. Departamento de Óptica, Farmacología y Anatomía, Studeny, Pavel, Hlozankova, Katerina, Krizova, Deli, Netukova, Magdalena, Veith, Miroslav, Mojzis, Peter, Piñero, David P., Universidad de Alicante. Departamento de Óptica, Farmacología y Anatomía, Studeny, Pavel, Hlozankova, Katerina, Krizova, Deli, Netukova, Magdalena, Veith, Miroslav, Mojzis, Peter, and Piñero, David P.
- Abstract
Purpose: To evaluate the long-term results of combining cataract surgery, intraocular lens (IOL) implantation, and Descemet membrane endothelial keratoplasty with peripheral stromal support (DMEK-S). Methods: The outcomes of 107 eyes of 37 patients who had undergone a combination of cataract surgery, IOL implantation, and DMEK-S between October 2007 and February 2015 were retrospectively evaluated. The average follow-up duration was 18.2 ± 18.3 months (range, 6–84 months). Changes in uncorrected and corrected distance visual acuity, spherical equivalent, and corneal endothelial cell density were analyzed. Intraoperative and postoperative complications were also recorded. Results: The mean logMAR uncorrected distance visual acuity improved from 0.92 ± 0.60 preoperatively to 0.33 ± 0.33, 0.28 ± 0.25, 0.24 ± 0.20, and 0.27 ± 0.27 at 6, 12, 24, and 36 months postoperatively (P < 0.001), respectively. The mean logMAR corrected distance visual acuity improved from 0.62 ± 0.65 preoperatively to 0.17 ± 0.29, 0.13 ± 0.21, 0.07 ± 0.16, and 0.11 ± 0.23 at 6, 12, 24, and 36 months postoperatively (P < 0.001), respectively. The mean endothelial cell density decreases were 50.7% ± 21.1%, 50.8% ± 19.8%, 60.7% ± 16.6%, 62.2% ± 11.8%, and 61.8% ± 20.0% at 6, 12, 24, 36, and 48 months after surgery, respectively. Similar trends, although with slightly better visual outcomes, were found in the subgroup of patients without other eye diseases. The mean final deviation from intended spherical equivalent was 0.77 ± 1.19 D, representing a hyperopic shift. Conclusions: A combined procedure of cataract surgery, IOL implantation, and DMEK-S is an effective method of treatment in patients with combined corneal disease and cataract, maintaining visual rehabilitation in the long term. Future developments should be performed to minimize the incidence of complications.
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- 2021
49. Two-year results of a combined regimen of aflibercept treatment in three types of choroidal neovascular membrane in the wet form of age-related macular degeneration: Real-life evidence in the Czech Republic
- Author
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Jan Studnička, M Penčák, Marketa Stredova, Jan Nemcansky, Alexandr Stepanov, Anna Tarkova, Katerina Manethova, and Miroslav Veith
- Subjects
030213 general clinical medicine ,medicine.medical_specialty ,genetic structures ,Recombinant Fusion Proteins ,Visual Acuity ,Angiogenesis Inhibitors ,03 medical and health sciences ,0302 clinical medicine ,Ophthalmology ,Age related ,Ranibizumab ,Choroidal neovascular membrane ,medicine ,Humans ,In patient ,Prospective Studies ,Aflibercept ,Czech Republic ,business.industry ,General Medicine ,Macular degeneration ,medicine.disease ,eye diseases ,Regimen ,Receptors, Vascular Endothelial Growth Factor ,Treatment Outcome ,Intravitreal Injections ,030221 ophthalmology & optometry ,Wet Macular Degeneration ,sense organs ,business ,medicine.drug - Abstract
Aim: To present the results of a 2-year therapy with aflibercept in real-life practice in a mixed regimen in patients with a neovascular form of age-related macular degeneration (nAMD) and to evaluate the treatment response of various types of choroidal neovascular membranes (CNV) – occult (Type 1), classic (Type 2) and minimally classic (Type 4). Methods: This was a multicentric, prospective, observational study of a series of cases. Patients diagnosed with the wet form of AMD were treated in a fixed regimen (3 injections at intervals of 1 month and then injections at 8-week intervals) in the first year, and in a pro re nata regimen (PRN) in the second year. The period of investigation was 24 months. The development of the best corrected visual acuity (BCVA) was evaluated by means of ETDRS optotypes (Early Treatment Diabetic Retinopathy Study) and the central retinal thickness (CRT). Measurements were performed prior to the commencement of therapy and then after 4, 8, 12, 16, 20 and 24 months. Results: The therapeutically naïve group consisted of 135 eyes of 135 patients. Sixty-one eyes suffered from CNV of the 1st type, 50 eyes from CNV of the 2nd type and 24 eyes from CNV of the 4th type. The average baseline of BCVA ± SD in Type 1 CNV was 56.1 ± 10.8 letters of ETDRS, and then, respectively, 62.2 ± 12.9 letters, 62.8 ± 15.1 letters and 59.4 ± 13.2 letters after 4, 12 and 24 months. The average baseline value of CRT ± SD for Type 1 CNV was 442.4 ± 194.9 µm, and then 302.5 ± 144.4 µm, 277.7 ± 106.5 µm and 327.6 ± 138.6 µm at months 4, 12 and 24. The average baseline value of BCVA ± SD in Type 2 CNV was 55.6 ± 9.9 letters of ETDRS, and then 62.5 ± 11.1 letters, 62.5 ± 14.2 letters and 60.6 ± 15.1 letters after 4, 12 and 24 months. The average baseline value of CRT ± SD in Type 2 CNV was 446.8 ± 159.1 µm, and then 327.4 ± 127.0 µm, 316.7 ± 139.1 µm and 352.5 ± 132.4 µm at 4, 12 and 24 months. In Type 4 CNV, the average baseline value of BCVA ± SD was 56.7 ± 9.0 letters of ETDRS, and then 59.1 ± 10.6 letters, 59.2 ± 12.6 letters and 58 ± 8.8 letters after 4, 12 and 24 months. The average baseline value of CRT ± SD in Type 4 CNV was 492.1 ± 187.0 µm, and then 333.3 ± 137.5 µm, 326.7 ± 122.4 µm and 328.4 ± 132 µm at months 4, 12 and 24. All these changes were statistically significant ( p Conclusion: Therapy with aflibercept in a mixed regimen in patients with the wet form of AMD during the investigation resulted in a statistically significant improvement in BCVA and decrease in CRT in both the occult and classic type of CNV. Both the functional and anatomical response to therapy was worse in the minimally classic type (Type 4) of CNV. Summary declaration: Patients suffering from the neovascular form of age-related macular degeneration were treated with aflibercept in a mixed regimen (fixed in the first year and PRN in the second year). After 24 months of examination, a significant improvement of both morphological and functional results was observed in three types of choroidal neovascular membrane.
- Published
- 2020
50. 25-gauge vitrectomy with gas tamponade for rhegmatogenous retinal detachment: experienced vs. inexperienced surgeons
- Author
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Miroslav Veith, Pavel Studeny, M Penčák, Jakub Dite, Stranák Z, and Jana Vranova
- Subjects
medicine.medical_specialty ,genetic structures ,business.industry ,Ophthalmology ,Medicine ,Retinal detachment ,Tamponade ,business ,medicine.disease ,25 gauge vitrectomy ,eye diseases - Abstract
Introduction: To compare the results and complication rates of a 25-gauge pars plana vitrectomy (PPV) with gas tamponade for rhegmatogenous retinal detachment (RRD) between experienced and inexperienced surgeons.Materials and Methods: This is a retrospective comparative consecutive case series study of patients with uncomplicated RRD treated with 25g PPV with gas tamponade. Patients were divided into 2 groups: In experienced surgeon group (ESG) the procedure was performed by an experienced vitreoretinal surgeon and in inexperienced surgeon group (ISG) the procedure was performed by 2 inexperienced surgeons. Anatomical and functional results and complication rates were compared between the two groups.Results: 216 eyes were included in the study. In the ESG (106 eyes), the single operation success rate was 94.3%, and the final success rate was 100%. In the ISG (110 eyes), the single operation success rate was 93.6%, and the final success rate was 100.0%. The difference in single surgery success rate between groups was not statistically significant (P = 0.828). The mean postoperative BCVA improvement was 0.348 decimal in ESG and 0.405 decimal in ISG (P = 0.234). The difference in complication rates between groups was not significant.Conclusions: A 25g PPV with gas tamponade for treatment of RRD yields excellent anatomical results and improvement in BCVA. With good technique and use of modern vitrectomy machines and instruments, even inexperienced surgeons can achieve high single operation success rate, suggesting a short learning curve. The complication rate is comparable between experienced and inexperienced surgeons.
- Published
- 2020
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