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1. Verteporfin Photodynamic Therapy Combined with Intravitreal Ranibizumab for Polypoidal Choroidal Vasculopathy Controversy Concerning Long-Term Followup

Author

Maribel Fernández, María Gil, Francisco Gomez-Ulla, and Pablo Charlón

Subjects
Medicine
Abstract

Purpose. To show the long-term results of intravitreal ranibizumab combined with photodynamic therapy (PDT) for the treatment of polypoidal choroidal vasculopathy (PCV). Methods. We analyzed the progress of two patients for 36 and 58 months, respectively. We only used PDT for the treatment in the area of the active PCV or “hot spot” evident on the indocyanine green angiography (ICGA). The spot size was chosen so as to cover only the active neovascular lesion. We combined intravitreal ranibizumab with PDT when PCV remained active without visible polyps in ICGA or without a response to PDT. Conclusion. Administration, as required, of verteporfin photodynamic therapy combined with intravitreal ranibizumab is an effective treatment for symptomatic polypoidal choroidal vasculopathy. These data need to be confirmed in large, prospective, and controlled clinical trials which are randomized and carried out over a long period.

Published
2012
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2. A Randomized Controlled Trial of OPT-302, a VEGF-C/D Inhibitor for Neovascular Age-Related Macular Degeneration

Author

Timothy L. Jackson, Jason Slakter, Marc Buyse, Kun Wang, Pravin U. Dugel, Charles C. Wykoff, David S. Boyer, Michael Gerometta, Megan E. Baldwin, Clare F. Price, Bohdan Kousal, Jan Studnicka, Michal Veith, Catherine Creuzot-Garcher, Flore De Bats, David Gaucher, Martine Mauget-Faysse, Eric Souied, Ramin Tadayoni, Andrea Facsko, Agnes Kerénvi, Andras Papp, Alexis Tsorbatzoglou, Gabor Vogt, Yoreh Barak, Itay Chowers, Michaella Goldstein, Joel Hanhart, Haya Morori-Katz, Irit Rosenblatt, Alexander Rubowitz, Oren Tomkins Netzer, Francesco Bandello, Antonio Ciardella, Federico Ricci, Giovanni Staurenghi, Gianni Virgili, Kristine Baumane, Guna Laganovska, Signe Ozolina, Ilze Strautmane, Bartlomiej Kaluzny, Jerzy Mackiewicz, Marta Misiuk-Hoilo, Ewa Mrukwa-Kominek, Piotr Oleksy, Krystyna Raczynska, Tomasz Zarnowski, Alfredo Adan, Javier Araiz, Anna Boixadera, Alvaro Fernández-Vega, Alfredo Garcia Layana, Francisco Gomez-Ulla, Javier Montero, Jose Maria Ruiz Moreno, David Gilmour, Timothy Jackson, Sidath Liyanage, Luke Membrey, Geeta Menon, Niro Narendran, Sobha Sivaprasad, Daniel Alfaro, Andrew Antoszyk, Carl Baker, Ivan Batille, Brian Berger, David Boyer, William Bridges, Harold Brooks, David Brown, Margaret Chang, Daniel Chao, Sanford Chen, Courtney Crawford, Pravin Dugel, Alexander Eaton, David Eichenbaum, Jordana Fein, Leonard Feiner, Christina Flaxel, Frank Garber, Alan Gordon, Sunil Gupta, Curtis Haegedorn, George Hampton, Thomas Hanscom, Vrinda Hershberger, Peter Kaiser, Randy Katz, Arshad Khanani, Erik Kruger, Denis Marcus, Matthew Ohr, Sunil Patel, Joel Pearlman, Richard Pesavento, Dante Pieramici, John Pitcher, Jay Prensky, John Randolf, Carl Regillo, Steven Rose, Michael Samuel, Todd Schneiderman, Sumit Shah, Michael Singer, Nathan Steinle, Glenn Stoller, Alan Thach, John Thompson, Michael Varenhorst, Alan Wagner, Joseph Walker, John Wells, Jonathan Williams, Robert Wong, and Charles Wykoff

Subjects
Ophthalmology
Published
2023
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3. 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

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

Subjects
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.

Published
2022
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4. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials

Author

Jeffrey S Heier, Arshad M Khanani, Carlos Quezada Ruiz, Karen Basu, Philip J Ferrone, Christopher Brittain, Marta S Figueroa, Hugh Lin, Frank G Holz, Vaibhavi Patel, Timothy Y Y Lai, David Silverman, Carl Regillo, Balakumar Swaminathan, Francesco Viola, Chui Ming Gemmy Cheung, Tien Y Wong, Ashkan Abbey, Elmira Abdulaeva, Prema Abraham, Alfredo Adan Civera, Hansjurgen Agostini, Arturo Alezzandrini, Virgil Alfaro, Arghavan Almony, Lebriz Altay, Payam Amini, Andrew Antoszyk, Etelka Aradi, Luis Arias, Jennifer Arnold, Riaz Asaria, Sergei Astakhov, Yury Astakhov, Carl C. Awh, Chandra Balaratnasingam, Sanjiv Banerjee, Caroline Baumal, Matthias Becker, Rubens Belfort, Galina Bratko, William Jr. Z Bridges, Jamin Brown, David M. Brown, Maria Budzinskaya, Sylvia Buffet, Stuart Burgess, Iksoo Byon, Carlo Cagini, Jorge Calzada, Stone Cameron, Peter Campochiaro, John Carlson, Angela Carneiro, Clement Chan, Emmanuel Chang, Andrew Chang, Daniel Chao, Nauman Chaudhry, Caroline Chee, Andrew Cheek, Shih-Jen Chen, San-Ni Chen, Gemmy Cheung, Saradha Chexal, Mark Chittum, David Chow, Abosede Cole, Brian Connolly, Pierre Loic Cornut, Stephen Couvillion, Carl Danzig, Vesselin Daskalov, Amr Dessouki, Francois Devin, Michael Dollin, Rosa Dolz, Louise Downey, Richard Dreyer, Pravin Dugel, David Eichenbaum, Bora Eldem, Robert Engstrom, Joan Josep Escobar, Nicole Eter, David W. Faber, Naomi Falk, Leonard Feiner, Alvaro Fernandez Vega, Philip Ferrone, Marta Figueroa, Howard Fine, Mitchell Fineman, Gregory M. Fox, Catherine Francais, Pablo Franco, Samantha Fraser-Bell, Nicholas Fung, Federico Furno Sola, Richard Gale, Alfredo Garcia-Layana, Julie Gasperini, Maciej Gawecki, Faruque Ghanchi, Manjot Gill, Michel Giunta, David Glaser, Michaella Goldstein, Francisco Gomez Ulla, Fumi Gomi, Victor Gonzalez, Jordan Graff, Sunil Gupta, Rainer Guthoff, Robyn Guymer, Anton Haas, Robert Hampton, Katja Hatz, Ken Hayashi, Jeffrey Heier, Ewa Herba, Vrinda Hershberger, Patrick Higgins, Nancy Holekamp, Shigeru Honda, James Howard, Allen Hu, Stephen Huddleston, Tomohiro Iida, Hiroko Imaizumi, Yasuo Ito, Yasuki Ito, Sujit Itty, Golnaz Javey, Cameron Javid, Tatsushi Kaga, Jakub Kaluzny, Se Woong Kang, Kapil Kapoor, Levent Karabas, Tsutomu Kawasaki, Patrick Kelty, Agnes Kerenyi, Arshad Khanani, Ramin Khoramnia, Rahul Khurana, Kazuhiro Kimura, Kendra Klein-Mascia, Namie Kobayashi, Laurent Kodjikian, Hideki Koizumi, Gregg Kokame, Alexey Kulikov, Henry Kwong, Robert Kwun, Timothy Lai, Chi-Chun Lai, Laurent Lalonde, Paolo Lanzetta, Michael Larsen, Adrian Lavina, Won Ki Lee, ji Eun Lee, Seong Lee, Jaime Levy, Lucas Lindsell, Mimi Liu, Nikolas London, Andrew Lotery, David Lozano Rechy, Alan Luckie, David Maberley, Takatoshi Maeno, Sajjad Mahmood, Fuad Makkouk, Dennis Marcus, Alan Margherio, Helene Masse, Hisashi Matsubara, Raj Maturi, Sonia Mehta, Geeta Menon, Jale Mentes, Mark Michels, Yoshinori Mitamura, Paul Mitchell, Quresh Mohamed, Jordi Mones, Rodrigo Montemayor Lobo, Javier Montero, Jeffrey Moore, Ryusaburo Mori, Haia Morori-Katz, Raj Mukherjee, Toshinori Murata, Maria Muzyka-Wozniak, Marco Nardi, Niro Narendran, Massimo Nicolo, Jared Nielsen, Tetsuya Nishimura, Kousuke Noda, Anna Nowinska, Hideyasu Oh, Matthew Ohr, Annabelle Okada, Piotr Oleksy, Shinji Ono, Sengul Ozdek, Banu Ozturk, Luis Pablo, Kyu Hyung Park, D. Wilki Parke, Maria Cristina Parravano, Praveen Patel, Apurva Patel, Sunil Patel, Sugat Patel, Daniel Pauleikhoff, Ian Pearce, Joel Pearlman, Iva Petkova, Dante Pieramici, Nadezhda Pozdeyeva, Jawad Qureshi, Dorota Raczynska, Juan Ramirez Estudillo, Rajiv Rathod, Hessam Razavi, Gayatri Reilly, Federico Ricci, Ryan Rich, Bożena Romanowska-Dixon, Irit Rosenblatt, Jose Maria Ruiz Moreno, Stefan Sacu, Habiba Saedon, Usman Saeed, Min Sagong, Taiji Sakamoto, Sukhpal Sandhu, Laura Sararols, Mario Saravia, Ramin Schadlu, Patricio Schlottmann, Tetsuju Sekiryu, András Seres, Figen Sermet, Sumit Shah, Rohan Shah, Ankur Shah, Thomas Sheidow, Veeral Sheth, Chieko Shiragami, Bartosz Sikorski, Rufino Silva, Lawrence Singerman, Robert Sisk, Torben L. Sørensen, Eric Souied, David-J Spinak, Giovanni Staurenghi, Robert Steinmetz, Glenn Stoller, Robert Stoltz, Eric Suan, Ivan Suner, Yzer Suzanne, Ramin Tadayoni, Kanji Takahashi, Kei Takayama, Alexandre Taleb, James Talks, Hiroko Terasaki, John Thompson, Edit Toth-Molnar, Khoi Tran, Raman Tuli, Eduardo Uchiyama, Attila Vajas, Janneke Van Lith-Verhoeven, Balazs Varsanyi, Gianni Virgili, Gábor Vogt, Michael Völker, David Warrow, Pamela Weber, John A. Wells, Sanjeewa Wickremasinghe, Mark Wieland, Geoff Williams, Thomas Williams, David Wong, King Wong, James Wong, Ian Wong, Robert Wong, Bogumil Wowra, Charles C. Wykoff, Ayana Yamashita, Kanako Yasuda, Gursel Yilmaz, Glenn Yiu, Ai Yoneda, Young Hee Yoon, Barak Yoreh, HyeongGon Yu, Seung Young Yu, Tatiana Yurieva, Alberto Zambrano, Barbara Zatorska, and Carlos Zeolite

Subjects
Aged, 80 and over, Male, Vascular Endothelial Growth Factor A, Recombinant Fusion Proteins, Visual Acuity, Angiogenesis Inhibitors, General Medicine, Drug Administration Schedule, Angiopoietin-2, Macular Degeneration, Receptors, Vascular Endothelial Growth Factor, Treatment Outcome, Double-Blind Method, Antibodies, Bispecific, Intravitreal Injections, Humans, Female, Aged
Abstract

Faricimab is a bispecific antibody that acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A. We report primary results of two phase 3 trials evaluating intravitreal faricimab with extension up to every 16 weeks for neovascular age-related macular degeneration (nAMD).TENAYA and LUCERNE were randomised, double-masked, non-inferiority trials across 271 sites worldwide. Treatment-naive patients with nAMD aged 50 years or older were randomly assigned (1:1) to intravitreal faricimab 6·0 mg up to every 16 weeks, based on protocol-defined disease activity assessments at weeks 20 and 24, or aflibercept 2·0 mg every 8 weeks. Randomisation was performed through an interactive voice or web-based response system using a stratified permuted block randomisation method. Patients, investigators, those assessing outcomes, and the funder were masked to group assignments. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48 (prespecified non-inferiority margin of four letters), in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (TENAYA NCT03823287 and LUCERNE NCT03823300).Across the two trials, 1329 patients were randomly assigned between Feb 19 and Nov 19, 2019 (TENAYA n=334 faricimab and n=337 aflibercept), and between March 11 and Nov 1, 2019 (LUCERNE n=331 faricimab and n=327 aflibercept). BCVA change from baseline with faricimab was non-inferior to aflibercept in both TENAYA (adjusted mean change 5·8 letters [95% CI 4·6 to 7·1] and 5·1 letters [3·9 to 6·4]; treatment difference 0·7 letters [-1·1 to 2·5]) and LUCERNE (6·6 letters [5·3 to 7·8] and 6·6 letters [5·3 to 7·8]; treatment difference 0·0 letters [-1·7 to 1·8]). Rates of ocular adverse events were comparable between faricimab and aflibercept (TENAYA n=121 [36·3%] vs n=128 [38·1%], and LUCERNE n=133 [40·2%] vs n=118 [36·2%]).Visual benefits with faricimab given at up to 16-week intervals demonstrates its potential to meaningfully extend the time between treatments with sustained efficacy, thereby reducing treatment burden in patients with nAMD.F Hoffmann-La Roche.

Published
2022
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6. Enzymatic Vitreolysis

Author

Fernando Lopez-Lopez, Maria Rodriguez-Blanco, Francisco Gomez-Ulla, and Joaquin Marticorena

Subjects
Diabetic Retinopathy, Endocrinology, Fibrinolytic Agents, Vitrectomy, Endocrinology, Diabetes and Metabolism, Humans, Hyaluronoglucosaminidase, Fibrinolysin, Vitreous Detachment, Macular Edema, Peptide Fragments
Abstract

In the absence of posterior vitreous detachment, vitreous cortex is adhered to the internal limiting lamina of the inner retina. This junction between the vitreous and the retina is thought to participate in the pathophysiology of diverse retinal diseases, including proliferative diabetic retinopathy and diabetic macular edema. Vitrectomy has been associated with decrease of macular edema and improvement of visual acuity in eyes of diabetic patients. Thus, many pharmacologic agents have been studied with the aim of inducing a posterior vitreous detachment in order to facilitate the surgical procedure and reduce complications of vitrectomy. More recently, different agents such as plasmin and microplasmin have shown to be able to induce a posterior vitreous detachment given as a single intravitreal injection. The aim of this article is to give a scope about the pharmacologic vitreolysis and posterior vitreous detachment studies and describe some ongoing clinical trials that will determine the efficacy and safety of these novel therapies for diabetic retinopathy.

Published
2009
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8. The Effect of Systemic Parameters and Baseline Characteristics in Short-Term Response Analysis with Intravitreal Ranibizumab in Treatment-Naive Patients with Neovascular Age-Related Macular Degeneration

Author

Laura García-Quintanilla, Pablo Almuiña-Varela, María José Rodríguez-Cid, María Gil-Martínez, Maximino J. Abraldes, Francisco Gómez-Ulla, Miguel González-Barcia, Cristina Mondelo-García, Ana Estany-Gestal, Francisco J. Otero-Espinar, Maribel Fernández-Rodríguez, and Anxo Fernández-Ferreiro

Subjects
ranibizumab, inflammatory, statins, uric acid, age-related macular degeneration, Pharmacy and materia medica, RS1-441
Abstract

Anti-vascular endothelial growth factor drugs keep being the main therapy for neovascular age-related macular degeneration (AMD). Possible predictive parameters (demographic, biochemical and/or inflammatory) could anticipate short-term treatment response with ranibizumab. 46 treatment-naive patients were included in a prospective observational study. They underwent three monthly injections of intravitreal ranibizumab for neovascular AMD and the clinical examination was made at baseline and one month after the third injection. Demographic characteristics, co-morbidities and concomitant treatments were recorded at the baseline visit. Biochemical parameters, complete blood count and inflammation biomarkers were also measured at these times. Uric Acid was found to be statistically significant with a one-point difference between good and poor responders in both basal and treated patients, but only in basal parameters was statistical significance reached (p = 0.007 vs. p = 0.071 in treated patients). Cholesterol and inflammatory parameters such as white blood cell count and neutrophils were significantly reduced over time when treated with intravitreal ranibizumab. On the other hand, women seemed to have a worse prognosis for short-term response to intravitreal ranibizumab treatment. Uric acid may help identify possible non-responders before initial treatment with ranibizumab, and cholesterol and white blood cells could be good candidates to monitor short-term response to ranibizumab treatment.

Published
2024
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9. Relationships between Patient-Reported Outcome Measures and Clinical Measures in Naïve Neovascular Age-Related Macular Degeneration Patients Treated with Intravitreal Ranibizumab

Author

Pablo Almuiña-Varela, Laura García-Quintanilla, María José Rodríguez-Cid, María Gil-Martínez, Maximino J. Abraldes, Francisco Gómez-Ulla, Ana Estany-Gestal, Jorge Miguel Alcántara-Espinosa, Maribel Fernández-Rodríguez, and Anxo Fernández-Ferreiro

Subjects
quality of life, patient-reported outcome measures, age-related macular degeneration, treat and extend, anti-VEGF, Medicine, Pharmacy and materia medica, RS1-441
Abstract

Our objective was to evaluate changes in patient-reported outcome measures using the NEI-VFQ 25 questionnaire during a treat and extend regimen in naive neovascular Age-Related Macular Degeneration patients, and its correlation with anatomical and functional data. We conducted a prospective observational study. Patients underwent a treat and extend regimen with intravitreal ranibizumab for neovascular Age-Related Macular Degeneration. Initial response was evaluated at 4th month, and subsequently in every follow-up visit. If a clinical response was achieved, the injection interval was extended in two-week increments, up to a maximum of 12 weeks. Quality of life was assessed using the NEI-VFQ 25 questionnaire at baseline, 4th months, and 12th months. Patients were categorized as good or poor responders based on Best corrected visual acuity, central foveal thickness, intraretinal fluid, or subretinal fluid. Treatment with ranibizumab led to a significant improvement in quality of life, with a mean increase in NEI-VFQ 25 score of 4.27 points in the 12th month. No significant differences in improvement were observed between good and poor responders. Quality of life scores in neovascular Age-Related Macular Degeneration patients improved with intravitreal treatment regardless of the clinical response. The early response following the loading phase could indicate better quality of life after one year of treatment, with Best corrected visual acuity being the clinical parameter with the greatest influence on quality of life.

Published
2024
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10. Colaboradores

Author

Acabá-Berrocal, Luis A., Civera, Alfredo Adán, de Toledo, Clara Álvarez, Gómez, Luis Amselem, Iribarren, Javier Araiz, Barquet, Luis Arias, Maresca, Félix Armada, Sánchez, Carolina Arruabarrena, Rementeria, Ernesto Basauri, Herreros, Javier Benítez, Berrocal, María H., Boyd, Samuel, Boyd, Carmen G., López, Francisco Cabrera, Mitjana, José M. Caminal, Navarro, Verónica Castro, Valenciano, Carlos Cava, Taulet, Enrique Cervera, Corral, Ana Clement, Fernández, Francisco Clement, Martín, Rosa Coco, Coma, Miguel Cordero, Dorta, Luis Cordovés, González, Eduardo Esteban, González, Álvaro Fernández-Vega, Sanz, Álvaro Fernández-Vega, Figueroa, Marta S., Rius, Alejandro Filloy, Moreno, Ignacio Flores, Arumí, José García, Fusté, Claudia García-Arumí, Layana, Alfredo García, Martínez, María Gil, Gómez-Benlloch, Alba, de Irazázabal, Francisco Gómez-Ulla, Grigera, Julio Daniel, Mestre, Ignasi Jürgens, Belles, Víctor Llorenç, Gálvez, María Isabel López, Guajardo, Lorenzo López, Parra, Daniel Lorenzo, da Silva, Rufino Martins, Hernández, Javier Montero, Moreno, Javier A. Montero, Reus, Jeroni Nadal, Vallejo, José Luis Olea, Bernardes, João Filipe Pedrosa, Pinilla, Carlos M., Bustamante, Antonio Piñero, Poposki, Vladimir, Quiroz-Mercado, Hugo, Torrente, Amanda Rey, Calixto, Hernán Andrés Ríos, Rodríguez, Francisco J., Rojas, Jimena, Medrano, Jorge Ruiz, Moreno, José María Ruiz, de Viteri Vázquez, Manuel Sáenz, Santos, Idaira Sánchez, Vega, Cristina Sánchez, Saravia, Mario Joaquín, Ledesma, Belén Torres, Vilaplana, Daniel, Vilaplana, Ferran, Wu, Andrés, Wu, Lihteh, Zambrano, Alberto, and Victori, Miguel Ángel Zapata

Published
2019
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11. Multimodality Imaging Approach for Combined Central Retinal Vein and Artery Occlusion: The Role of Optical Coherence Tomography Angiography

Author

Marta Díez-Sotelo, Maximino Abraldes, and Francisco Gómez-Ulla

Subjects
optical coherence tomography angiography, retinal vein occlusion, retinal artery occlusion, fluorescein angiography, imaging retina, Ophthalmology, RE1-994
Abstract

Combined central retinal artery and vein occlusion is an uncommon vascular pathology that can cause severe and permanent visual impairment. Optical coherence tomography angiography (OCTA) is a newly available, noninvasive imaging technique that can potentially improve understanding of the structural and vascular implications and prognosis of this infrequent pathology. The present report describes the principal clinical findings in a case of combined central retinal artery and vein occlusion, as detected by the different imaging modalities available in a tertiary referral hospital. OCTA wide-field montage images identified an extensive area of nonperfusion on the macula with involvement of the entire retina at nearly 360°. We observed the most severe nonperfusion in the deep capillary plexus, while perfusion of the choriocapillaris was unaffected. Meanwhile, fluorescein angiography (FA) findings revealed a delay in perfusion rate with marked nonperfusion areas in the peripheral retina at 360°. We identified that the wide-field OCTA montage permitted visualization of a similar or wider peripheral retinal area compared with FA. Therefore, OCTA is potentially useful for assessment of the global retinal nonperfusion status at baseline and during follow-up, with the added advantage of being a noninvasive technique.

Published
2019
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12. A Comparative Cost Analysis of Digital Fundus Imaging and Direct Fundus Examination for Assessment of Diabetic Retinopathy.

Author

Francisco Gomez-Ulla, Florentina Alonso, Beatriz Aibar, and Francisco Gonzalez

Subjects
*PHYSICIANS, *PROFESSIONS, *OCCUPATIONS, *MEDICAL personnel
Abstract

The cost of direct funduscopic examination by an ophthalmologist was compared to the cost of digital nonmydriatic funduscopy with store-and-forward review by an ophthalmologist and indicated referral to an ophthalmologist. In this series, retinopathy was identified in 27% of patients in the digital group, and those patients were referred for ophthalmology consultation. An additional 4% had inadequate digital images and were referred for direct examination. The cost analysis considered personnel, capital, and consumable costs plus travel and loss of wages for patients. From the health service perspective, direct fundus examination is less costly than using digital fundus images. The higher cost of the digital fundus option is a consequence of the higher capital costs. However, from a global perspective, the digital image alternative is more convenient because the travel cost and loss of income of the patient are lower. [ABSTRACT FROM AUTHOR]

Published
2008
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13. Colaboradores

Author

Abecia Martínez, Emilio, Abelairas Gómez, José, Abraldes López-Veiga, Maximino J., Adán Civera, Alfredo, Alfonso Sánchez, José F., Alió y Sanz, Jorge L., Ares García, Jorge, Arranz Márquez, Esther, Arriola Villalobos, Pedro, Arruga Ginebreda, Jorge, Ascaso Puyuelo, Francisco Javier, Azuara-Blanco, Augusto, Baamonde Arbaiza, Begoña, Badal Lafulla, Josep, Barrio Barrio, Jesús, del Castillo Sánchez, José Manuel Benítez, del Castillo Sánchez, Javier Benítez, Buigues Llull, Ania, Cabral, Joao, Caire González-Jáuregui, José María, Calvo Pérez, Pilar, Canut Jordana, M.ª Isabel, Capeans Tomé, Carmela, Casaroli-Marano, Ricardo P., Cava Valenciano, Carlos, Che Hamzah, Jemaima, Cristóbal Bescós, José Ángel, Cuiña Sardiña, Ricardo, de Hoz Montañana, Rosa, de la Cuadra Blanco, Crótida, de la Paz Dalisay, María Fideliz, de las Heras Polo, Beatriz, Devoto, Martín H., Díaz-Llopis, Manuel, Díaz-Valle, David, de la Colina, Juan Durán, Encinas Martín, José Luis, Escribano Martínez, Julio, Jiménez-Ortiz, Héctor Fernández, Fernández Robredo, Patricia, Fernández Rodríguez, Maribel, Fernández Tirado, Francisco Javier, Fernández Vidal, Ana, Fernández-Vega Sanz, Luis, Fernández-Vigo Escribano, Cristina, Fernández-Vigo López, José, Ferreras Amez, Antonio, Gallego Collado, Beatriz, Gallego-Pinazo, Roberto, Gálvez Ruiz, Alberto, García-Feijóo, Julián, García Layana, Alfredo, García Martín, Elena, García Sáenz, Sofía, García Sánchez, Julián, García-Arumí, José, García-Delpech, Salvador, Genol Saavedra, Ignacio, Goldmicht, Mauro, de Liaño, Rosario Gómez, de Irazazábal, Francisco Gómez-Ulla, de la Rosa, Manuel González, Grau Díez, Arturo, Guarneri, Adriano, Güerri Monclús, Noemí, Hernández García, Elena, Herrero Vanrell, Rocío, Honrubia López, Francisco, Idoipe Corta, Míriam, Jáñez García, Lucía, Lacosta Asin, Vanesa, Larrosa Poves, José Manuel, López Abad, Consuelo, Macarro Merino, Ana, de la Casa, José María Martínez, Martínez Grau, Gorka, Martínez Grau, Ainhoa, Méndez Fernández, Rosalía, Méndez Hernández, Carmen, Mérida Velasco, José Ramón, de Imperial Mora-Figueroa, Jaime Miralles, Montero Moreno, Javier, Morales Fernández, Laura, Moreno-Montañés, Javier, Muñoz Negrete, Francisco José, Nadal Reus, Jeroni, Nogueira Goriba, Araceli, Palomo-Álvarez, Catalina, Pastor Jimeno, José Carlos, Pastora Salvador, Natalia, Peces Peña, María Dolores, Peralta Calvo, Jesús, Pérez Moreiras, Jose Vicente, Pérez-Salvador García, Eduardo, Pérez Salvador, José Luis, Pérez-Santonja, Juan José, Pinilla Lozano, Isabel, Polo Llorens, Vicente, Prada Sánchez, María Concepción, Pueyo Royo, Victoria, Ramírez Sebastián, Ana I., Ramírez Sebastián, José M., Rayward, Omar, Rebolleda Fernández, Gema, Recalde Mestre, Sergio, Rodríguez Ares, Teresa, Rodríguez Maiztegui, Idoia, Rojas López, Blanca, Ruiz Moreno, José María, Ruiz Moreno, Óscar, Ruiz Tolosa, Francisco, Sádaba Echarri, Luis Manuel, Sáenz Francés, Federico, Salazar Corral, Juan J., Sales Sanz, Andrea, Sales Sanz, Marco, Salinas Alamán, Ángel, Sauvageot Beneria, Paola, Sellés Navarro, Inmaculada, Tejada Palacios, Pilar, Teus Guezala, Miguel Ángel, Tit-Liviv Stoica, Bazil, Toledano Fernández, Nicolás, Torras Sanvicens, Josep, Tovilla-Canales, José Luis, Triviño Casado, Alberto, Vázquez Moliní, José M.ª, Vidal Sanz, Manuel, Villegas Pérez, María Paz, Viver Oller, Sonia, Won Kim, Hae-Ryung, Zapata Victori, Miguel Ángel, and Gómez de Liaño, Miguel Zato

Published
2012
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15. Automatic segmentation of the foveal avascular zone in ophthalmological OCT-A images.

Author

Macarena Díaz, Jorge Novo, Paula Cutrín, Francisco Gómez-Ulla, Manuel G Penedo, and Marcos Ortega

Subjects
Medicine, Science
Abstract

Angiography by Optical Coherence Tomography (OCT-A) is a non-invasive retinal imaging modality of recent appearance that allows the visualization of the vascular structure at predefined depths based on the detection of the blood movement through the retinal vasculature. In this way, OCT-A images constitute a suitable scenario to analyze the retinal vascular properties of regions of interest as is the case of the macular area, measuring the characteristics of the foveal vascular and avascular zones. Extracted parameters of this region can be used as prognostic factors that determine if the patient suffers from certain pathologies (such as diabetic retinopathy or retinal vein occlusion, among others), indicating the associated pathological degree. The manual extraction of these biomedical parameters is a long, tedious and subjective process, introducing a significant intra and inter-expert variability, which penalizes the utility of the measurements. In addition, the absence of tools that automatically facilitate these calculations encourages the creation of computer-aided diagnosis frameworks that ease the doctor's work, increasing their productivity and making viable the use of this type of vascular biomarkers. In this work we propose a fully automatic system that identifies and precisely segments the region of the foveal avascular zone (FAZ) using a novel ophthalmological image modality as is OCT-A. The system combines different image processing techniques to firstly identify the region where the FAZ is contained and, secondly, proceed with the extraction of its precise contour. The system was validated using a representative set of 213 healthy and diabetic OCT-A images, providing accurate results with the best correlation with the manual measurements of two experts clinician of 0.93 as well as a Jaccard's index of 0.82 of the best experimental case in the experiments with healthy OCT-A images. The method also provided satisfactory results in diabetic OCT-A images, with a best correlation coefficient with the manual labeling of an expert clinician of 0.93 and a Jaccard's index of 0.83. This tool provides an accurate FAZ measurement with the desired objectivity and reproducibility, being very useful for the analysis of relevant vascular diseases through the study of the retinal micro-circulation.

Published
2019
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16. Efficacy and Safety of an Aflibercept Treat-and-Extend Regimen in Treatment-Naïve Patients with Macular Oedema Secondary to Central Retinal Vein Occlusion (CRVO): A Prospective 12-Month, Single-Arm, Multicentre Trial

Author

Jose Garcia-Arumi, Francisco Gómez-Ulla, Navea Amparo, Enrique Cervera, Alex Fonollosa, Luis Arias, Javier Araiz, Juan Donate, Marta Suárez de Figueroa, Lucia Manzanas, Jaume Crespí, and Roberto Gallego

Subjects
Ophthalmology, RE1-994
Abstract

Objectives. To evaluate efficacy and safety of an aflibercept treat-and-extend (TAE) regimen in patients with macular oedema (MO) secondary to central retinal vein occlusion (CRVO). Design, Setting, and Patients. Phase IV, prospective, open-label, single-arm trial in 11 Spanish hospitals. Treatment-naïve patients with

Published
2018
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17. Automatic Visual Acuity Estimation by Means of Computational Vascularity Biomarkers Using Oct Angiographies

Author

Macarena Díaz, Marta Díez-Sotelo, Francisco Gómez-Ulla, Jorge Novo, Manuel Francisco G. Penedo, and Marcos Ortega

Subjects
optical coherence tomography by angiography, visual acuity, retinal vein occlusion, artificial vision, biomarkers, Chemical technology, TP1-1185
Abstract

Optical Coherence Tomography Angiography (OCTA) constitutes a new non-invasive ophthalmic image modality that allows the precise visualization of the micro-retinal vascularity that is commonly used to analyze the foveal region. Given that there are many systemic and eye diseases that affect the eye fundus and its vascularity, the analysis of that region is crucial to diagnose and estimate the vision loss. The Visual Acuity (VA) is typically measured manually, implying an exhaustive and time-consuming procedure. In this work, we propose a method that exploits the information of the OCTA images to automatically estimate the VA with an accurate error of 0.1713.

Published
2019
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18. Review of Intraocular Pharmacokinetics of Anti-Infectives Commonly Used in the Treatment of Infectious Endophthalmitis

Author

Andrea Luaces-Rodríguez, Miguel González-Barcia, María José Blanco-Teijeiro, María Gil-Martínez, Francisco Gonzalez, Francisco Gómez-Ulla, María-Jesús Lamas, Francisco-Javier Otero-Espinar, and Anxo Fernández-Ferreiro

Subjects
anti-infectives, intravitreal, endophthalmitis, pharmacokinetics, infection, Pharmacy and materia medica, RS1-441
Abstract

Although intravitreal administration of anti-infectives represents the standard treatment for infectious endophthalmitis, the knowledge about their pharmacokinetics is still limited. In this review, we aimed to summarise the factors influencing the pharmacokinetics of the anti-infective agents. We have conducted a comprehensive review of the preclinical pharmacokinetic parameters obtained in different studies of intravitreal injections of anti-infectives performed on animals, mainly rabbits. The two aspects with the biggest influence on pharmacokinetics are the distribution in the vitreous humour and the elimination through the posterior segment. The distribution can be affected by the molecular weight of the drug, the convection flow of the vitreous, the condition of the vitreous humour depending on the age of the patient, the possible interactions between the drug and the components of the vitreous, and the presence of vitrectomy. Meanwhile, the elimination includes the metabolism of the drug, the clearance via the anterior and posterior routes, and the possible inflammation of the eye resulting from the disease. Understanding the pharmacokinetics of the anti-infectives used in clinical practice is essential for a correct application. The information provided in this review could offer guidance for selecting the best therapeutic option according to the characteristics of the drugs.

Published
2018
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19. Individualized Therapy with Ranibizumab in Wet Age-Related Macular Degeneration

Author

Alfredo García-Layana, Marta S. Figueroa, Luis Arias, Javier Araiz, José María Ruiz-Moreno, José García-Arumí, Francisco Gómez-Ulla, María Isabel López-Gálvez, Francisco Cabrera-López, José Manuel García-Campos, Jordi Monés, Enrique Cervera, Felix Armadá, and Roberto Gallego-Pinazo

Subjects
Ophthalmology, RE1-994
Abstract

Individualized treatment regimens may reduce patient burden with satisfactory patient outcomes in neovascular age-related macular degeneration. Intravitreal anti-VEGF drugs are the current gold standard. Fixed monthly injections offer the best visual outcome but this regimen is not commonly followed outside clinical trials. A PRN regimen requires monthly visits where the patient is treated in the presence of signs of lesion activity. Therefore, an early detection of reactivation of the disease with immediate retreatment is crucial to prevent visual acuity loss. Several trials suggest that “treat and extend” and other proactive regimens provide a reasonable approach. The rationale of the proactive regimens is to perform treatment anticipating relapses or recurrences and therefore avoid drops in vision while individualizing patient followup. Treat and extend study results in significant direct medical cost savings from fewer treatments and office visits compared to monthly treatment. Current data suggest that, for one year, PRN is less expensive, but treat and extend regimen would likely be less expensive for subsequent years. Once a patient is not a candidate to continue with treatment, he/she should be sent to an outpatient unit with adequate resources to follow nAMD patients in order to reduce the burden of specialized ophthalmologist services.

Published
2015
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20. Do Nutritional Supplements Have a Role in Age Macular Degeneration Prevention?

Author

Maria D. Pinazo-Durán, Francisco Gómez-Ulla, Luis Arias, Javier Araiz, Ricardo Casaroli-Marano, Roberto Gallego-Pinazo, Jose J. García-Medina, Maria Isabel López-Gálvez, Lucía Manzanas, Anna Salas, Miguel Zapata, Manuel Diaz-Llopis, and Alfredo García-Layana

Subjects
Ophthalmology, RE1-994
Abstract

Purpose. To review the proposed pathogenic mechanisms of age macular degeneration (AMD), as well as the role of antioxidants (AOX) and omega-3 fatty acids (ω-3) supplements in AMD prevention. Materials and Methods. Current knowledge on the cellular/molecular mechanisms of AMD and the epidemiologic/experimental studies on the effects of AOX and ω-3 were addressed all together with the scientific evidence and the personal opinion of professionals involved in the Retina Group of the OFTARED (Spain). Results. High dietary intakes of ω-3 and macular pigments lutein/zeaxanthin are associated with lower risk of prevalence and incidence in AMD. The Age-Related Eye Disease study (AREDS) showed a beneficial effect of high doses of vitamins C, E, beta-carotene, and zinc/copper in reducing the rate of progression to advanced AMD in patients with intermediate AMD or with one-sided late AMD. The AREDS-2 study has shown that lutein and zeaxanthin may substitute beta-carotene because of its potential relationship with increased lung cancer incidence. Conclusion. Research has proved that elder people with poor diets, especially with low AOX and ω-3 micronutrients intake and subsequently having low plasmatic levels, are more prone to developing AMD. Micronutrient supplementation enhances antioxidant defense and healthy eyes and might prevent/retard/modify AMD.

Published
2014
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21. A Delphi Study to Detect Deficiencies and Propose Actions in Real Life Treatment of Neovascular Age-Related Macular Degeneration

Author

Alfredo García-Layana, Luis Arias, Marta S. Figueroa, Javier Araiz, José María Ruiz-Moreno, José García-Arumí, Francisco Gómez-Ulla, María Isabel López-Gálvez, Francisco Cabrera-López, José Manuel García-Campos, Jordi Monés, Enrique Cervera, Felix Armadá, Roberto Gallego-Pinazo, Antonio Piñero-Bustamante, and Miguel Angel Serrano-Garcia

Subjects
Ophthalmology, RE1-994
Abstract

Purpose. Spanish retina specialists were surveyed in order to propose actions to decrease deficiencies in real-life neovascular age macular degeneration treatment (nv-AMD). Methods. One hundred experts, members of the Spanish Vitreoretinal Society (SERV), were invited to complete an online survey of 52 statements about nv-AMD management with a modified Delphi methodology. Four rounds were performed using a 5-point Linkert scale. Recommendations were developed after analyzing the differences between the results and the SERV guidelines recommendations. Results. Eighty-seven specialists completed all the Delphi rounds. Once major potential deficiencies in real-life nv-AMD treatment were identified, 15 recommendations were developed with a high level of agreement. Consensus statements to reduce the burden of the disease included the use of treat and extend regimen and to reduce the amount of diagnostic tests during the loading phase and training technical staff to perform these tests and reduce the time between relapse detection and reinjection, as well as establishing patient referral protocols to outside general ophthalmology clinics. Conclusion. The level of agreement with the final recommendations for nv-AMD treatment among Spanish retinal specialist was high indicating that some actions could be applied in order to reduce the deficiencies in real-life nv-AMD treatment.

Published
2014
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22. Smoking and Age-Related Macular Degeneration: Review and Update

Author

Sara Velilla, José Javier García-Medina, Alfredo García-Layana, Rosa Dolz-Marco, Sheila Pons-Vázquez, M. Dolores Pinazo-Durán, Francisco Gómez-Ulla, J. Fernando Arévalo, Manuel Díaz-Llopis, and Roberto Gallego-Pinazo

Subjects
Ophthalmology, RE1-994
Abstract

Age-related macular degeneration (AMD) is one of the main socioeconomical health issues worldwide. AMD has a multifactorial etiology with a variety of risk factors. Smoking is the most important modifiable risk factor for AMD development and progression. The present review summarizes the epidemiological studies evaluating the association between smoking and AMD, the mechanisms through which smoking induces damage to the chorioretinal tissues, and the relevance of advising patients to quit smoking for their visual health.

Published
2013
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24. Sterile Endophthalmitis after Intravitreal Injections

Author

Joaquín Marticorena, Vito Romano, and Francisco Gómez-Ulla

Subjects
Pathology, RB1-214
Abstract

Sterile endophthalmitis appears as an infrequent complication of intravitreal injections and seems to develop mainly in the context of the off-label use of drugs that have not been conceived for intravitreous administration. The aetiology of sterile endophthalmitis, independently of the administered drug, remains uncertain and a multifactorial origin cannot be discarded. Sterile inflammation secondary both to intravitreal triamcinolone acetonide and to intravitreal bevacizumab share many characteristics such as the acute and painless vision loss present in the big majority of the cases. Dense vitreous opacity is a common factor, while anterior segment inflammation appears to be mild to moderate. In eyes with sterile endophthalmitis, visual acuity improves progressively as the intraocular inflammation reduces without any specific treatment. If by any chance the ophthalmologist is not convinced by the sterile origin of the inflammation, this complication must be treated as an acute endophthalmitis because of the devastating visual prognosis of this intraocular infection in the absence of therapy.

Published
2012
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25. Autores

Author

Hernández, Santiago Abengoechea, Civera, Alfredo Adán, Iribarren, Javier Araiz, Barquet, Luis Arias, Maresca, Félix Armadá, Sánchez, Carolina Arruabarrena, Buil Calvo, José Antonio, López, Francisco Cabrera, Caminal Mitjana, Josep M.ª, Navarro, Joaquín Castro, Mora, Jaume Català, Taulet, Enrique Cervera, Martín, Inés Contreras, Vilimelis, Jaume Crespi, Carmen Desco Esteban, M.ª, López, Juan Donate, González, Eduardo Esteban, Fernández-Vega Sanz, Álvaro, Rodríguez, Maribel Fernández, Gil, Marta Fonollá, García Alonso, Ana María, Arumí, José García, Layana, Alfredo García, Pous, María García, De Irazazábal, Francisco Gómez-Ulla, Gálvez, Maribel López, Boronat, Jorge Mataix, Carilla, Jordi Monés, Montero Moreno, Javier A., Tejerina, Amparo Navea, Martín, Susana Noval, Olea Vallejo, José Luis, Pozo, Elena Palacios, Salvador, Natalia Pastora, Colás, Laura Pelegrín, Calvo, Jesús Peralta, Bustamante, Antonio Piñero, Poposki, Vladimir, Goyta, Octavio Pujol, Rubio Caso, Marcos Javier, Ruiz-Moreno, José María, Suárez-Figueroa, Marta, Fernández-Blanco, Clemencia Torrón, i Blanch, Daniel Vilaplana, Deleu, Eva Villota, Oller, Sònia Viver, and Zapata Victori, Miguel Ángel

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