Safety and Efficacy of Ranibizumab in Diabetic Macular Edema (RESOLVE Study)

• DOI: 10.2337/dc10-0493
• Publication Date: 2010-10-27T19:41:04Z
• Authors: Pascale Massin; Francesco Bandello; Justus G. Garweg; Lutz L. Hansen; Simon P. Harding; Michael Larsen; Paul Mitchell; Dianne Sharp; U.E.K. Wolf-Schnu...; Margarita Gekkieva; Andreas Weichselb...; Sebastian Wolf
• Keywords: Diabetic macular edema

The expression of vascular endothelial growth factor (VEGF) is elevated in diabetic macular edema (DME). Ranibizumab binds to and inhibits multiple VEGF variants. We investigated the safety efficacy ranibizumab DME involving foveal center.This was a 12-month, multicenter, sham-controlled, double-masked study with eyes (age>18 years, type 1 or 2 diabetes, central retinal thickness [CRT]≥300 μm, best corrected visual acuity [BCVA] 73-39 ETDRS letters [Early Treatment Diabetic Retinopathy Study]) randomly assigned intravitreal (0.3 0.5 mg; n=51 each) sham (n=49). treatment schedule comprised three monthly injections, after which could be stopped/reinitiated an opportunity for rescue laser photocoagulation (protocol-defined criteria). After month 1, dose-doubling permitted criteria, injection volume increased from 0.05 0.1 ml remained at thereafter). Efficacy (BCVA CRT) were compared between pooled arms using full analysis set (n=151, patients receiving≥1 injection).At 12, mean±SD BCVA improved baseline by 10.3±9.1 declined 1.4±14.2 (P<0.0001). Mean CRT reduction 194.2±135.1 μm 48.4±153.4 Gain ≥10 occurred 60.8% 18.4% Safety data consistent previous studies ranibizumab.Ranibizumab effective improving well tolerated DME. Future clinical trials are required confirm its long-term safety.