Original articleIntravitreal Aflibercept (VEGF Trap-Eye) in Wet Age-related Macular Degeneration
Section snippets
Study Design
The “VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD” studies (VIEW 1 and VIEW 2) were similarly designed, prospective, double-masked, multinational, parallel-group, active-controlled, randomized clinical trials. The investigators from the VIEW 1 and VIEW 2 studies are listed in Appendix 1, available at http://aaojournal.org. Patients in VIEW 1 (registered at www.clinicaltrials.gov on July 31, 2007; NCT00509795. Accessed August 8, 2012) were randomized at 154 sites in the United
Patient Disposition, Baseline Characteristics, and Exposure
The disposition of patients is shown in Figure 1A-B. In VIEW 1, 1217 patients were randomized, with 91.1% to 96.4% of patients completing 52 weeks. In VIEW 2, 1240 patients were randomized, with 88.1% to 91.1% completing 52 weeks. Baseline demographics and disease characteristics were evenly balanced among all treatment groups (Table 1). The mean number of active injections received by patients in all monthly treatment arms, which were scheduled to receive 13 monthly injections, was 12.1 to
Discussion
We have described 2 large and similarly designed clinical trials involving more than 2400 patients with neovascular AMD. In both trials, all 3 aflibercept treatment regimens (including the every-2-month regimen after 3 initial monthly loading doses) were statistically noninferior to monthly ranibizumab in preventing moderate visual acuity loss at 1 year, meeting the primary outcome of the trials; all the aflibercept regimens also met the stricter margin of 5% for clinical equivalence compared
Acknowledgments
The authors thank Karen Chu, MS, Regeneron Pharmaceuticals, Inc, and Avner Ingerman, MD, initial study director of VIEW 1 and former employee of Regeneron Pharmaceuticals, Inc, for assistance with the design of the studies. Editorial and administrative assistance to the authors who wrote the manuscript was provided by S. Balachandra Dass, PhD, Regeneron Pharmaceuticals, Inc.
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Manuscript no. 2012-1120.
Financial Disclosure(s): The author(s) have made the following disclosure(s): J.S.H. is a consultant to and has received research funding from Alimera, Allergan, Fovea, Genentech, Genzyme, GlaxoSmithKline, Neovista, and Regeneron Pharmaceuticals. He has also received travel support from Regeneron Pharmaceuticals. D.M.B. is a consultant to Alimera, Allergan, Bayer, Genentech/Roche, Novartis, Regeneron Pharmaceuticals, and Thrombogenics and has received research funding from Alcon, Alimera, Allergan, Eli Lilly, Genentech, GlaxoSmithKline, Novartis, Regeneron Pharmaceuticals, and Thrombogenics. He has also received travel support from Regeneron Pharmaceuticals and lecture fees from Genentech. V.C. is a consultant to Alimera and Bayer and has received research funding from Alcon, Allergan, Bayer, Novartis, and Pfizer. He is an advisory board member for Allergan and Novartis and has also received travel support from Bayer. J.-F.K. is a consultant to Alcon, Bayer, and Thea and an advisory board member for Allergan, Bayer, and Novartis. He has received travel support from Regeneron Pharmaceuticals. P.K.K. is a consultant to Bayer, Genentech, Novartis, and Regeneron Pharmaceuticals. He has received research funding from Regeneron Pharmaceuticals. Q.D.N. is a consultant to Bausch & Lomb and Santen and has received research funding from Genentech, Novartis, and Pfizer. B.K. has received travel support from Bayer. A.H. is a consultant to Alcon, Allergan, Centocor, Johnson & Johnson, Neovista, Merck, Ophthotech, Oraya, Paloma, P.R.N., Q.L.T., Regeneron Pharmaceuticals, and Thrombogenics. He has received research funding and lecture fees from Alcon, Allergan, Genentech, Neovista, Ophthotech, Oraya, P.R.N., Q.L.T., Regeneron Pharmaceuticals, and Second Sight. Y.O. is a consultant to Alcon and Bayer and has received travel support from Bayer. G.D.Y., N.S., R.V., A.J.B., and Y.S. are employees of Regeneron Pharmaceuticals. MA, G.G., B.S., and R.S. are employees of Bayer HealthCare. C.S.'s institution has received payments from the Medical University of Vienna for data monitoring/reviewing and statistical analysis. U.S.-E. is a consultant to Alcon, Allergan, Bayer HealthCare, and Novartis, and an advisory board member for Alcon and Novartis. She has received travel support from Bayer HealthCare and lecture fees from Bayer HealthCare and Novartis.
G.D.Y. and N.S., incorporating the advice of a panel of academic and physician experts, developed the initial proposal for the VIEW 1 study design. The study design of both studies was further developed and finalized by the academic authors and clinical and statistical authors from Regeneron Pharmaceuticals and Bayer HealthCare (sponsors). The sponsors conducted the trials and together with the investigators gathered the data. Study conduct and analyses were supervised by the Study Steering Committees and the sponsors. The Writing Committee consisting of authors J.S.H., D.M.B., V.C., and U.S.-E. (subteam of VIEW Steering Committees) along with G.D.Y. composed the first draft of the paper, which was critically revised and finalized by the input of all coauthors. The Writing Committee members and all other authors met authorship criteria. All coauthors had full and unrestricted access to the data and decided to publish the paper vouching for the accuracy and completeness of the reported data.
Funding: Sponsored by Regeneron Pharmaceuticals, Inc, Tarrytown, New York, and Bayer HealthCare, Berlin Germany. The sponsors participated in the design and conduct of the study, analysis of the data, and preparation of the manuscript.
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Group members listed online in Appendix 1 (http://aaojournal.org).