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1. 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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2. Three-Year, Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Diabetic Macular Edema

Author

David S. Boyer, 1 Young Hee Yoon, MD, PhD, 2 Rubens Belfort, Jr, MD, PhD, 3 Francesco Bandello, 4 Raj K. Maturi, 5 Albert J. Augustin, 6 Xiao Yan Li, 7 Harry Cui, 7 Yehia Hashad, 7 Scott M. Whitcup, MDThe MEAD Study Group Principal Investigators: Suel Abujamra, James Acton, Fareed Ali, Andrew Antoszyk, Albert J. Augustin, Carl C. Awh, Adiel Barak, Karl Ulrich Bartz Schmidt, Caroline R. Baumal, Rubens Belfort, J.r., Muna Bhende, William Z. Bridges, David M. Brown, Trevor Carmichael, Ken Carnevale, Antonio M. Casella, Tom Chang, Daniel Chechik, San Ni Chen, Lawrence P. Chong, Victor Chong, Joel Corwin, Catherine Creuzot Garcher, Alan Cruess, Mark Daniell, Marcos P. de Avila, Haroldo Vieira de Moraes, Robert G. Devenyi, Bernard H. Doft, Mark Donaldson, Richard Dreyer, Dean Eliott, Harry M. Engel, Jan Ernest, Thomas F. Essman, Philip M. Falcone, Sharon Fekrat, Joseph R. Ferencz, Joao L. Ferreira, Joao Figueira, Ivan Fiser, Bradley Foster, Gregory M. Fox, William R. Freeman, S. P. Garg, Mark Gillies, David Glaser, Burton G. Goldstein, Andre M. V. Gomes, John R. Gonder, Lingam Gopal, Petrus Gous, Amod Gupta, Anurag Gupta, Lawrence Halperin, Dennis Han, Seenu M. Hariprasad, Frank G. Holz, Peter Kaiser, Bohdana Kalvodova, Barrett Katz, Randy S. Katz, Dariusz Kecik, Judianne Kellaway, Itamar Klemperer, Baruch Kuppermann, Paolo Lanzetta, Rosangela Lattanzio, Won Ki Lee, John Lehr, Monique Leys, Isaac Loose, Andrew Lotery, Da Wen Lu, Paul McCartney, Ajit B. Majji, Jose A. Martinez, Pascale Massin, Raj K. Maturi, Ugo Menchini, Geeta Menon, Mark Michels, Edoardo Midena, James Miller, Paul Mitchell, Joseph Moisseiev, Lawrence Morse, Rafael Navarro, Janos Nemeth, Henry Newland, Richard Newsom, John Nichols, Juan Orellana, Nicola Orzalesi, Augusto Paranhos, Robert Park, Susanna Park, Maurizio Battaglia Parodi, Peter R. Pavan, James Peace, Don J. Perez Ortiz, Ayala Pollack, Kim Ramaswamy, Ramakrishna Ratnakaram, Giuseppe Ravalico, Jiri Rehak, Kourous Rezaei, Stanislao Rizzo, Francisco J. Rodriguez Alvira, Jean Paul Romanet, Steven Rose, Richard B. Rosen, Luca Rossetti, Jose Maria Ruiz Moreno, SriniVas Sadda, Kenneth Sall, Dirk Sandner, Alvaro Fernandez Vega Sanz, Gil Sartani, Stefanie Schmickler, Steven D. Schwartz, Y. R. Sharma, Shwu Jiuan Sheu, Michael Singer, Sobha Sivaprasad, Gisele Soubrane, Petr Soucek, Eric H. Souied, Giovanni Staurenghi, Jan Studnicka, Marta Suarez Figueroa, Walter Y. Takahashi, Patrick L. Tsai, Lawrence J. Ulanski, Harvey Uy, Monica Varano, Miroslav Veith, Igor Vicha, Francesco Viola, Linda Visser, Dov Weinberger, Glenn L. Wing, Edmund Wong, Tien Wong, Edward Wylegala, Jiong Yan, Young Hee Yoon, Lucy H. Young, Hyeong G. Yu, Ingrid E. Zimmer Galler, TOGNETTO, DANIELE, Boyer, D, Yoon, Yh, Belfort, R, Bandello, Francesco, Maturi, Rk, Augustin, Aj, Li, Xy, Cui, H, Hashad, Y, Whitcup, Sm, David S., Boyer, Md, 1 Young Hee, Yoon, Md, Phd, 2 Rubens, Belfort, Jr, Md, Phd, 3 Francesco, Bandello, 4 Raj K., Maturi, 5 Albert J., Augustin, 6 Xiao Yan, Li, 7 Harry, Cui, Ms, 7 Yehia, Hashad, 7 Scott M., Whitcup, MDThe MEAD Study Group Principal Investigators: Suel, Abujamra, James, Acton, Fareed, Ali, Andrew, Antoszyk, Albert J., Augustin, Carl C., Awh, Adiel, Barak, Karl Ulrich Bartz, Schmidt, Caroline R., Baumal, Rubens, Belfort, J., R., Muna, Bhende, William Z., Bridge, David M., Brown, Trevor, Carmichael, Ken, Carnevale, Antonio M., Casella, Tom, Chang, Daniel, Chechik, San Ni, Chen, Lawrence P., Chong, Victor, Chong, Joel, Corwin, Catherine Creuzot, Garcher, Alan, Crue, Mark, Daniell, Marcos P., de Avila, Haroldo Vieira de, Morae, Robert G., Devenyi, Bernard H., Doft, Mark, Donaldson, Richard, Dreyer, Dean, Eliott, Harry M., Engel, Jan, Ernest, Thomas F., Essman, Philip M., Falcone, Sharon, Fekrat, Joseph R., Ferencz, Joao L., Ferreira, Joao, Figueira, Ivan, Fiser, Bradley, Foster, Gregory M., Fox, William R., Freeman, S. P., Garg, Mark, Gillie, David, Glaser, Burton G., Goldstein, Andre M. V., Gome, John R., Gonder, Lingam, Gopal, Petrus, Gou, Amod, Gupta, Anurag, Gupta, Lawrence, Halperin, Dennis, Han, Seenu M., Hariprasad, Frank G., Holz, Peter, Kaiser, Bohdana, Kalvodova, Barrett, Katz, Randy S., Katz, Dariusz, Kecik, Judianne, Kellaway, Itamar, Klemperer, Baruch, Kuppermann, Paolo, Lanzetta, Rosangela, Lattanzio, Won Ki, Lee, John, Lehr, Monique, Ley, Isaac, Loose, Andrew, Lotery, Da Wen, Lu, Paul, Mccartney, Ajit B., Majji, Jose A., Martinez, Pascale, Massin, Raj K., Maturi, Ugo, Menchini, Geeta, Menon, Mark, Michel, Edoardo, Midena, James, Miller, Paul, Mitchell, Joseph, Moisseiev, Lawrence, Morse, Rafael, Navarro, Janos, Nemeth, Henry, Newland, Richard, Newsom, John, Nichol, Juan, Orellana, Nicola, Orzalesi, Augusto, Paranho, Robert, Park, Susanna, Park, Maurizio Battaglia, Parodi, Peter R., Pavan, James, Peace, Don J., Perez Ortiz, Ayala, Pollack, Kim, Ramaswamy, Ramakrishna, Ratnakaram, Giuseppe, Ravalico, Jiri, Rehak, Kourous, Rezaei, Stanislao, Rizzo, Francisco J., Rodriguez Alvira, Jean Paul, Romanet, Steven, Rose, Richard B., Rosen, Luca, Rossetti, Jose Maria Ruiz, Moreno, Srinivas, Sadda, Kenneth, Sall, Dirk, Sandner, Alvaro Fernandez Vega, Sanz, Gil, Sartani, Stefanie, Schmickler, Steven D., Schwartz, Y. R., Sharma, Shwu Jiuan, Sheu, Michael, Singer, Sobha, Sivaprasad, Gisele, Soubrane, Petr, Soucek, Eric H., Souied, Giovanni, Staurenghi, Jan, Studnicka, Marta Suarez, Figueroa, Walter Y., Takahashi, Tognetto, Daniele, Patrick L., Tsai, Lawrence J., Ulanski, Ii, Harvey, Uy, Monica, Varano, Miroslav, Veith, Igor, Vicha, Francesco, Viola, Linda, Visser, Dov, Weinberger, Glenn L., Wing, Edmund, Wong, Tien, Wong, Edward, Wylegala, Jiong, Yan, Young Hee, Yoon, Lucy H., Young, Hyeong G., Yu, and Ingrid E., Zimmer Galler

Subjects
Adult, Male, Intraocular pressure, Triamcinolone acetonide, Visual acuity, genetic structures, Anti-Inflammatory Agents, Visual Acuity, Phases of clinical research, Dexamethasone, Macular Edema, law.invention, Randomized controlled trial, law, Health Sciences, Dexamethasone Intravitreal Implant (Ozurdex, Dexamethasone Intravitreal Implant, Humans, Medicine, Aged, Aged, 80 and over, Drug Implants, Diabetic Retinopathy, business.industry, Area under the curve, Middle Aged, Ophthalmology, DEX implant Diabetic Macular Edemat, Area Under Curve, Anesthesia, Intravitreal Injections, Dexamethasone Intravitreal Implant (Ozurdex, DEX implant Diabetic Macular Edemat, Female, Implant, medicine.symptom, business, hormones, hormone substitutes, and hormone antagonists, medicine.drug
Abstract

Purpose: To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema (DME).Design: Two randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols were conducted. Data were pooled for analysis.Participants: Patients (n = 1048) with DME, best-corrected visual acuity (BCVA) of 20/50 to 20/200 Snellen equivalent, and central retinal thickness (CRT) of ≥300 μm by optical coherence tomography.Methods: Patients were randomized in a 1:1:1 ratio to study treatment with DEX implant 0.7 mg, DEX implant 0.35 mg, or sham procedure and followed for 3 years (or 39 months for patients treated at month 36) at ≤40 scheduled visits. Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months.Main Outcome Measures: The predefined primary efficacy endpoint for the United States Food and Drug Administration was achievement of ≥15-letter improvement in BCVA from baseline at study end. Safety measures included adverse events and intraocular pressure (IOP).Results: Mean number of treatments received over 3 years was 4.1, 4.4, and 3.3 with DEX implant 0.7 mg, DEX implant 0.35 mg, and sham, respectively. The percentage of patients with ≥15-letter improvement in BCVA from baseline at study end was greater with DEX implant 0.7 mg (22.2%) and DEX implant 0.35 mg (18.4%) than sham (12.0%; P ≤ 0.018). Mean average reduction in CRT from baseline was greater with DEX implant 0.7 mg (−111.6 μm) and DEX implant 0.35 mg (−107.9 μm) than sham (−41.9 μm; P < 0.001). Rates of cataract-related adverse events in phakic eyes were 67.9%, 64.1%, and 20.4% in the DEX implant 0.7 mg, DEX implant 0.35 mg, and sham groups, respectively. Increases in IOP were usually controlled with medication or no therapy; only 2 patients (0.6%) in the DEX implant 0.7 mg group and 1 (0.3%) in the DEX implant 0.35 mg group required trabeculectomy.Conclusions: The DEX implant 0.7 mg and 0.35 mg met the primary efficacy endpoint for improvement in BCVA. The safety profile was acceptable and consistent with previous reports.

Published
2014
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3. Monthly versus as-needed ranibizumab injections in patients with retinal vein occlusion: the SHORE study

Author

Peter A, Campochiaro, Charles C, Wykoff, Michael, Singer, Robert, Johnson, Dennis, Marcus, Linda, Yau, and Gary, Sternberg

Subjects
Male, Ranibizumab, Intravitreal Injections, Retinal Vein Occlusion, Visual Acuity, Humans, Angiogenesis Inhibitors, Female, Middle Aged, Antibodies, Monoclonal, Humanized, Drug Administration Schedule, Macular Edema, Aged
Abstract

To compare pro re nata (PRN) and monthly injections of 0.5 mg ranibizumab in retinal vein occlusion (RVO) patients stabilized by monthly injections.Randomized, open-label, vision-examiner masked, 15-month study.Subjects with macular edema secondary to branch or central RVO.Subjects received monthly injections of 0.5 mg ranibizumab for 7 months and those meeting stability criteria between months 7 and 14 were randomized (1:1) to PRN injections versus continued monthly injections. Non-randomized (NR) subjects (never met stability criteria) received monthly injections.The primary endpoint was the slope of change in best-corrected visual acuity (BCVA) between months 7 and 15.There was no significant difference in the slope of change in BCVA between months 7 and 15 in patients treated PRN versus those treated with monthly injections (P = 0.509). Mean (± standard deviation) change from baseline BCVA in Early Treatment Diabetic Retinopathy Study letter score at month 15 was 21.0 ± 14.1 in the PRN group (n = 82) versus 18.7 ± 14.1 in the monthly group (n = 80) and 14.5 ± 14.7 in NR subjects (n = 13). The percentage of subjects who achieved BCVA ≥ 20/40 at month 15 was 76.8% in the PRN group, 71.3% in the monthly group, and 46.2% in NR subjects. The mean (± standard deviation) change from baseline central subfield thickness was -247.8 ± 207.5 μm in the PRN group, -289.9 ± 177.2 μm in the monthly group, and -93.2 ± 225.2 μm in NR subjects. There were no significant differences in mean BCVA gains or central subfield thickness reductions at month 15 between the PRN and monthly injection groups (all0.05).After edema resolution from 7 or more monthly ranibizumab injections in RVO subjects, visual outcomes at month 15 were excellent and not significantly different in subjects treated PRN versus those who continued monthly injections.

Published
2013

4. Epimacular brachytherapy for neovascular age-related macular degeneration: a randomized, controlled trial (CABERNET)

Author

Pravin U, Dugel, Judith D, Bebchuk, Jeffrey, Nau, Elias, Reichel, Michael, Singer, Adiel, Barak, Susanne, Binder, Timothy L, Jackson, and D, Weinberger

Subjects
Aged, 80 and over, Male, Brachytherapy, Visual Acuity, Angiogenesis Inhibitors, Radiotherapy Dosage, Middle Aged, Antibodies, Monoclonal, Humanized, Treatment Outcome, Ranibizumab, Intravitreal Injections, Strontium Radioisotopes, Wet Macular Degeneration, Humans, Female, Macula Lutea, Yttrium Radioisotopes, Fluorescein Angiography, Aged, Follow-Up Studies
Abstract

To evaluate the safety and efficacy of epimacular brachytherapy (EMBT) for the treatment of neovascular age-related macular degeneration (AMD).Multicenter, randomized, active-controlled, phase III clinical trial.Four hundred ninety-four participants with treatment-naïve neovascular AMD.Participants with classic, minimally classic, and occult lesions were randomized in a 2:1 ratio to EMBT or a ranibizumab monotherapy control arm. The EMBT arm received 2 mandated, monthly loading injections of 0.5 mg ranibizumab. The control arm received 3 mandated, monthly loading injections of ranibizumab then quarterly injections. Both arms also received monthly as needed (pro re nata) retreatment.The proportion of participants losing fewer than 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters from baseline visual acuity (VA) and the proportion gaining more than 15 ETDRS letters from baseline VA.At 24 months, 77% of the EMBT group and 90% of the control group lost fewer than 15 letters. This difference did not meet the prespecified 10% noninferiority margin. This end point was noninferior using a 20% margin and a 95% confidence interval for the group as a whole and for classic and minimally classic lesions, but not for occult lesions. The EMBT did not meet the superiority end point for the proportion of participants gaining more than 15 letters (16% for the EMBT group vs. 26% for the control group): this difference was statistically significant (favoring controls) for occult lesions, but not for predominantly classic and minimally classic lesions. Mean VA change was -2.5 letters in the EMBT arm and +4.4 letters in the control arm. Participants in the EMBT arm received a mean of 6.2 ranibizumab injections versus 10.4 in the control arm. At least 1 serious adverse event occurred in 54% of the EMBT arm, most commonly postvitrectomy cataract, versus 18% in the control arm. Mild, nonproliferative radiation retinopathy occurred in 3% of the EMBT participants, but no case was vision threatening.The 2-year efficacy data do not support the routine use of EMBT for treatment-naïve wet AMD, despite an acceptable safety profile. Further safety review is required.

Published
2012

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