Long-term Effects of Therapy with Ranibizumab on Diabetic Retinopathy Severity and Baseline Risk Factors for Worsening Retinopathy

摘要: Purpose To assess the effects of intravitreal ranibizumab on diabetic retinopathy (DR) severity when administered for up to 3 years, evaluate effect delayed initiation therapy DR severity, and identify baseline patient characteristics associated with development proliferative (PDR). Design Exploratory analyses phase III, randomized, double-masked, sham-controlled multicenter clinical trials. Participants Adults macular edema (DME) (N = 759), best-corrected visual acuity 20/40 20/320 Snellen equivalent, central foveal thickness ≥275 μm. Methods Patients were randomized monthly 0.3 or 0.5 mg sham injections. Sham participants could switch during third year (sham/0.5 crossover). Baseline risk factors evaluated explore potential associations PDR. Time first PDR was analyzed by Kaplan–Meier methods calculate cumulative probabilities group. Main Outcome Measures Study eye change Early Treatment Diabetic Retinopathy scale a composite outcome evaluating progression based photographic changes plus clinically important events defining Results At month 36, greater proportion ranibizumab-treated eyes had ≥2- ≥3-step improvement compared sham/0.5 crossover. A achieved at 36 months 3.3%, 15.0%, 13.2% mg, eyes, respectively ( P Conclusions Ranibizumab, as patients DME 12 in these studies, can both improve prevent worsening. Prolonged delays may limit this therapeutic effect. Although uncommon, still occurs small percentage undergoing anti–vascular endothelial growth factor be related presence nonperfusion.