Original articleIntravitreal Aflibercept Injection for Neovascular Age-related Macular Degeneration: Ninety-Six–Week Results of the VIEW Studies
Section snippets
Design
The VIEW 1 and 2 studies were 2 similarly designed randomized, double-masked, active-controlled, parallel-group, multicenter, 96-week phase 3 trials comparing the efficacy and safety of intravitreal aflibercept and ranibizumab in patients with neovascular AMD.16 The VIEW 1 study was carried out from July 2007 through July 2011 in the United States and Canada, and the VIEW 2 study was carried out from April 2008 through August 2011 in Europe, the Middle East, the Asia-Pacific region, and Latin
Patient Disposition and Baseline Characteristics
The VIEW 1 and 2 studies randomized a total of 2457 patients; 2419 (98.5%) patients received at least 1 dose of study medication, and 2245 (91.4%) patients completed 52 weeks of study. A total of 2235 (91.0%) patients entered the second year, and 2063 (84.0%) patients completed 96 weeks of study. The percentage of patients completing the study was similar among treatment groups at both weeks 52 and 96 (Table 1, available at http://aaojournal.org). Reasons for discontinuation before week 96
Discussion
The results from the follow-up regimen of mandatory quarterly dosing with intervening as-needed injections (capped PRN) in the second year of the VIEW studies confirm the sustained improvements in visual acuity, central retinal thickness, and CNV size achieved by fixed dosing regimens of intravitreal aflibercept and ranibizumab during the first year.16 All intravitreal aflibercept regimens were as effective as ranibizumab in increasing visual acuity and reducing retinal thickness and CNV size
Acknowledgments
The authors thank Hadi Moini, PhD, and S. Balachandra Dass, PhD, of Regeneron Pharmaceuticals, Inc, for editorial and administrative assistance to the authors who wrote the manuscript.
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Financial Disclosure(s): The author(s) have made the following disclosure(s): Ursula Schmidt-Erfurth: Consultant – Bayer HealthCare, Alcon, Allergan, Bohringer, Novartis; Financial support – Bayer HealthCare; Advisory board – Alcon, Allergan, Bohringer, Novartis; Lecturer – Alcon, Allergan, Bohringer, Novartis
Peter K. Kaiser: Consultant – Alcon, Bayer HealthCare, Genentech, Novartis, Regeneron Pharmaceuticals
Jean-Francois Korobelnik: Consultant – Bayer HealthCare, Carl Zeiss Meditec, Novartis, Roche, Thea; Advisory board – Alcon, Allergan; Financial support – Regeneron Pharmaceuticals
David M. Brown: Consultant and Financial support – Alcon, Allergan, Bayer HealthCare, Genentech/Roche, Novartis, Regeneron Pharmaceuticals, Thrombogenics
Victor Chong: Consultant – Allergan, Bayer HealthCare, Novartis, Quantel; Financial support – Allergan, Novartis, Bayer HealthCare; Lecturer – Bayer HealthCare, Heidelberg, Novartis; Travel – Bayer Healthcare.
Quan Dong Nguyen: Consultant – Bausch & Lomb, Santen; Financial support – Genentech, Pfizer, Regeneron Pharmaceuticals
Allen C. Ho: Consultant – Regeneron Pharmaceuticals; Financial support – Regeneron Pharmaceuticals, Alcon, Allergan, Genentech, Neovista, Ophthotech, Oraya, P.R.N., Q.L.T., Regeneron Pharmaceuticals, Second Sight; Lecturer – Alcon, Allergan, Genentech, Neovista, Ophthotech, Oraya, P.R.N., Q.L.T., Regeneron Pharmaceuticals, Second Sight
Yuichiro Ogura: Consultant – Alcon, Bayer HealthCare, Santen; Lecturer – Alcon, Santen, Novartis; Financial support – Bayer HealthCare
Christian Simader: the author's institution, the Medical University of Vienna, has received funding from Bayer Healthcare for data monitoring/reviewing, statistical analysis, and travel
Glenn J. Jaffe: the author's institution, Duke University, has received research funding from Regeneron Pharmaceuticals to serve as a masked reading center
Jason S. Slakter: Consultant – Lpath, Ohr, Oraya, Regeneron Pharmaceuticals; Financial support and Lecturer – Regeneron Pharmaceuticals; the author's institution, Vitreous-Retina-Macula Consultants of New York, has received research funding from Bayer HealthCare, Centor, Genentech, Genzyme, GlaxoSmithKline, Kanghong Biotech, Lpath, NeoVista, Ohr, Oraya, Regeneron Pharmaceuticals, and Santen to serve as an Angiography Reading Center
George D. Yancopoulos: Employee – Regeneron Pharmaceuticals
Neil Stahl: Employee – Regeneron Pharmaceuticals
Robert Vitti: Employee – Regeneron Pharmaceuticals
Alyson J. Berliner: Employee – Regeneron Pharmaceuticals
Yuhwen Soo: Employee – Regeneron Pharmaceuticals
Majid Anderesi: Employee – Bayer HealthCare
Olaf Sowade: Employee – Bayer HealthCare
Oliver Zeitz: Employee – Bayer HealthCare
Christiane Norenberg: Employee – Bayer HealthCare
Rupert Sandbrink: Employee – Bayer HealthCare
Jeffrey S. Heier: Consultant – Acucela, Aerpio, Alimera, Allergan, Bausch & Lomb, Bayer HealthCare, Dutch Ophthalmic, Endo Optiks, Forsight, Genzyme, Heidelberg Engineering, Kala Pharmaceuticals, Kanghong, LPath, Nicox, Notal Vision, Ohr Pharmaceutical, Ophthotech, Oraya, QLT, Regeneron Pharmaceuticals, Roche, Sequenom, Thrombogenics, Vertex, Xcovery; Financial support – Acucela, Aerpio, Alcon, Alimera, Allergan, Bayer HealthCare, Fovea, Genentech, Genzyme, GlaxoSmithKline, LPath, Neovista, Notal Vision, Novartis, Ohr Pharmaceutical, Ophthotech, Paloma, Regeneron Pharmaceuticals
The VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) studies were funded by Regeneron Pharmaceuticals, Inc, Tarrytown, New York, and Bayer HealthCare, Berlin, Germany. The sponsor-authors participated in the design and conduct of the study, analysis of the data, and preparation of the manuscript.