Comparing the effectiveness of bevacizumab to ranibizumab in patients with exudative age-related macular degeneration. BRAMD

Abstract

Purpose: To compare the effectiveness of bevacizumab and ranibizumab in the treatment of exudative age-related macular degeneration (AMD). In patients ≥ 60 years of age with primary or recurrent sub- or juxtafoveal choroidal neovascularization (CNV) secondary to AMD with a total area of CNV < 12 disc areas and a best corrected visual acuity (BCVA) score between 20 and 78 letters on an EDTRS like chart in the study eye.

Methods: In this double-masked clinical trial 327 patients were randomized to 1.25 mg bevacizumab or 0.5 mg ranibizumab given as monthly intravitreal injections during one year. Intention to treat with last observation carried forward analysis was performed. Primary outcome was the change in BCVA in the study eye from baseline to 12 months. The non-inferiority margin was set at 4 letters. Secondary outcomes were the proportions of patients with a gain or loss ≥ 15 letters or more, a BCVA ≥ 20/40 or more at 12 months, the change in central area retinal thickness (CRT) by optical coherence tomography (OCT) at 4 and 12 months and the number of adverse events in 12 months.

Results: Bevacizumab (n=161) was not inferior to ranibizumab (n=166). The mean gain in BCVA was 5.1 (±14.1) letters in the bevacizumab group and 6.4 (±12.2) letters in the ranibizumab group (p= 0.37). The lower limit of the 95% confidence interval of the difference in BCVA gain between the two groups was 3.72. The response to bevacizumab was more varied than in the ranibizumab group, with 24% of patients showing a gain of ≥15 letters, 11% a loss of ≥15 letters and 65% a gain or loss < 15 letters in the bevacizumab group compared to 19%, 5% and 76% respectively in the ranibizumab group (p=0.038). No significant differences in absolute CRT and CRT change at 12 months (p=0.13) were observed, but any sub- or intraretinal fluid on OCT was observed more frequently in the bevacizumab group (45% vs 31 %, p=0.020). The occurrence of serious adverse events and adverse events was similar in the two groups, with 34 SAEs and 256 AEs in the bevacizumab group and 37 SAEs and 299 AEs in the ranibizumab group (p= 0.87 and p=0.48, respectively).

Conclusions: The efficacy of bevacizumab was not inferior to ranibizumab. The response to bevacizumab was more varied with higher percentages of both gainers and losers and more frequently observed retinal fluid on OCT at 12 months when compared to the ranibizumab group.

Keywords: 412 age-related macular degeneration • 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • 748 vascular endothelial growth factor