Abstract
Purpose: :
To evaluate the efficacy and safety of intravitreal bevacizumab for the treatment of exudative AMD.
Methods: :
Prospective, multi-center, double-masked, randomized, controlled trial. Participants were randomly assigned (1:1) to intravitreal bevacizumab or standard therapy available when the trial commenced (PDT, pegaptanib sodium or sham treatment). The primary end-point was gain in vision at 12 months. A data and safety monitoring committee and steering committee monitored the conduct of the study.
Results: :
Of the 131 patients enrolled in the trial, 32.3 % of patients in the bevacizumab group gained 15 or more letters from baseline visual acuity, compared to 3.0% in the standard care group [(P<0.001), estimated adjusted odds ratio 18.1 (3.61, 91.24)]. 90.8% of patients in the bevacizumab lost less than 15 letters of visual acuity from baseline compared to 66.7% in the standard care group ( P<0.001). There were no cases of endophthalmitis or serious uveitis related to the intervention. All end points with respect to visual acuity in the study eye at 54 weeks favored bevacizumab treatment over standard care therapy.
Conclusions: :
Intravitreal bevacizumab given as part of a 6 weekly variable retreatment regimen is superior to standard care (PDT, pegaptanib sodium or sham) in the treatment of exudative AMD. This study provides the first level I evidence for the use of bevacizumab in the treatment of CNV in AMD.
Clinical Trial: :
www.ISRCTN.org ISRCTN83325075
Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: outcomes/complications • vascular endothelial growth factor