A randomized observer and subject masked trial comparing the visual outcome after treatment with ranibizumab or bevacizumab in patients with neovascular age‐related macular degeneration

Abstract

AbstractPurpose The western world health care systems are confronted with an increasing burden of patients suffering from age‐related macular degeneration (AMD). Anti‐VEGF therapy revolutionized the treatment of exudative AMD, but is associated with high costs. This study seeks to compare the treatment effects of ranibizumab and bevacizumab on best corrected distance visual acuity (BCVA) in Austrian patients with neovascular AMD.Methods This was a prospective, randomized, double blind, multicenter study. Ten clinical trial centers in Austria participated in this one year lasting study and included 321 treatment naïve patients suffering from neovascular AMD. Patients were randomized for treatment with bevacizumab or ranibizumab receiving a loading dose of three consecutive monthly intravitreal injections, followed by monthly treatment as needed.Results No significant differences were seen in BCVA between ranibizumab (n = 167) and bevacizumab (n = 154) groups. At one year bevacizumab was equivalent to ranibizumab (p=0.78 between groups). This was also not significant when adjusted for age or baseline BCVA. Also the gain and loss of 5 or 15 letters in BCVA showed no significant difference between treatment groups. Finally the analysis of serious adverse events (SAE) revealed no significant difference between the two groups, although SAEs were slightly more in the bevacizumab group.Conclusion The findings of this study showed no significant difference at one year between the two drugs used in an as needed manner, which displays todays most widely spread treatment regimen. The drugs showed similar efficacy and safety in the Austrian population.