Patel, P.J.; (2012) Bevacizumab for neovascular age-related macular degeneration: clinical trial and repeatability of outcome measures. Doctoral thesis , UCL (University College London).

Abstract

Aim: To evaluate the efficacy and safety of intravitreous bevacizumab for the treatment of neovascular age-related macular degeneration (nAMD). Methods: Prospective, multi-centre, double-masked, randomised, controlled trial. Participants were randomly assigned (1:1) to intravitreal bevacizumab or standard therapy available when the trial commenced (photodynamci therapy, Macugen 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)j. 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 favoured bevacizumab treatment over standard care therapy. Conclusion: Intravitreous bevacizumab given as part of a 6 weekly variable retreatment regimen is superior to standard care (pegaptanib sodium, verterporfin, sham) in the treatment of nAMD. This study provides the first level I evidence for the use of bevacizumab in the treatment of CNV in AMD.

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