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Ranibizumab versus bevacizumab for neovascular age‐related macular degeneration: Results from the GEFAL noninferiority randomized trial
Author(s) -
KODJIKIAN L,
SOUIED EH,
MIMOUN G,
DECULLIER E,
HUOT L,
AULAGNER G
Publication year - 2013
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2013.4461.x
Subject(s) - ranibizumab , medicine , bevacizumab , macular degeneration , randomized controlled trial , adverse effect , ophthalmology , regimen , visual acuity , surgery , chemotherapy
Purpose To evaluate the relative efficacy and safety profile of bevacizumab versus ranibizumab intravitreal injections for treatment of neovascular age‐related macular degeneration (AMD) Methods Multicenter, prospective, non‐inferiority, double‐masked, randomized clinical trial, performed in 38 French ophthalmology centers. Patients were randomly assigned to intravitreal administration of bevacizumab (1.25 mg) or ranibizumab (0.50 mg). Patients were followed for one year, with a loading dose of three monthly intravitreal injections, followed by an as‐needed regimen (one injection in case of active disease) for the remaining nine months with monthly follow‐up. Results Between June 2009 and November 2011, 501 patients were randomized. In the per protocol analysis, bevacizumab was non‐inferior to ranibizumab (bevacizumab minus ranibizumab +1.89 letters, 95% confidence interval ‐1.16 to +4.93, p<0.0001). The intention‐to‐treat analysis was concordant. The mean numbers of injections were 6.8 in the bevacizumab group and 6.5 in the ranibizumab group (p=0.39). Both drugs reduced the central subfield macular thickness, with a mean decrease of 95 µm for bevacizumab and 107 µm for ranibizumab (p=0.27). There were no significant differences in anatomical secondary criteria. The proportion of patients with serious adverse events was 12.6% in the bevacizumab group and 12.1% in the ranibizumab group (p=0.88). The proportion of patients with serious systemic or ocular adverse events was similar in both groups. Conclusion Bevacizumab was non‐inferior to ranibizumab for visual acuity at one year with similar safety profiles. The results are similar to previous head‐to‐head studies.