Original articleRanibizumab versus Bevacizumab for Neovascular Age-related Macular Degeneration: Results from the GEFAL Noninferiority Randomized Trial
Section snippets
Design
The GEFAL study is a prospective, noninferiority, double-masked, randomized clinical trial performed in public and private French ophthalmology centers.
Study Population
Patients aged >50 years were eligible if they met the following inclusion criteria for the study eye (1 eye per patient): (1) best-corrected visual acuity (BCVA) between 20/32 and 20/320 (Snellen equivalent) measured on Early Treatment of Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 m; (2) active subfoveal neovascular AMD; and
Patients
Overall, 501 patients were enrolled in 38 French centers between June 24, 2009, and November 9, 2011. According to our population definition, 374 patients (75%) were available for the per protocol analysis (Fig 1): 191 treated with bevacizumab and 183 treated with ranibizumab.
The initial demographic, clinical, OCT, and angiographic characteristics were similar between the 2 groups except for history of hypertension (Table 1). Mean BCVA at baseline was 54.6 letters in the bevacizumab group and
Discussion
Bevacizumab was found to be noninferior to ranibizumab with a difference in mean change in BCVA (bevacizumab minus ranibizumab) of +1.89 letters (95% CI, −1.16 to +4.93), which was confirmed by the intention-to-treat analysis.
These findings point in the same direction as those of the CATT study, which demonstrated that bevacizumab and ranibizumab had equivalent effects on visual acuity at 1 year14 (and at 2 years15) whether administered monthly or as needed. The MANTA study also found similar
Acknowledgments
The authors thank Professor Michel Lièvre for methodological assistance.
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Financial Disclosure(s): The author(s) have made the following disclosure(s): L.K. is the Principal Investigator for trials sponsored by Novartis, Bausch & Lomb, Théa, and Alcon; has sat on advisory boards for Alcon, Allergan, Bayer, Bausch & Lomb, Novartis, and Théa; and has received lecture fees from Alcon, Allergan, Bayer, Bausch & Lomb, the Krys group, Novartis, Théa, and Zeiss. E.H.S. has received honoraria from Novartis, Bayer, and Allergan; has sat on advisory boards for Bausch & Lomb and Théa; and has received lecture fees from Bausch & Lomb and consulting fees from Novartis, Bayer, and Allergan. G.M. has received lecture fees from Allergan and Novartis. M.M-F. has sat on advisory boards for Novartis and Bayer, and has received lecture fees from Théa and Heidelberg Engineering. F.B-C., E.D., L.H., and G.A. declared no conflicts of interest.
Supported by a grant from the French Ministry of Health (“Programme Hospitalier de Recherche Clinique National 2008”). The French Health Insurance System co-financed the study and funded drugs. The funding organizations had no role in designing or carrying out this research.
∗Group members listed in Appendix 1 (available at http://aaojournal.org).
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The GEFAL Study Group members are listed in Appendix 1 (available at http://aaojournal.org).