Clinically meaningful visual improvements and predictors of early vision gains with ranibizumab for diabetic macular oedema

OBJECTIVE: To determine the time to first clinically meaningful improvement in best-corrected visual acuity (BCVA) in patients treated with ranibizumab for diabetic macular oedema (DME) and identify predictors of early visual improvement. METHODS AND ANALYSIS: We retrospectively analysed the phase III RIDE (NCT00473382) and RISE (NCT00473330) trials, in which 759 patients with DME were randomised to monthly intravitreal ranibizumab 0.3 mg (n=250), ranibizumab 0.5 mg (n=252) or sham treatment (n=257). After month 24, 191 sham-treated patients crossed over to monthly ranibizumab 0.5 mg through month 36, while ranibizumab-treated patients continued treatment. Kaplan-Meier analyses assessed time to achieve ≥15 or ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS) letter gains from baseline or ≥20/40 Snellen equivalent BCVA in each treatment arm. Baseline predictors of ≥15 ETDRS letter gains at month 6 were identified by logistic regression. RESULTS: Median time to first ≥15 ETDRS letter gain was significantly shorter in patients who received ranibizumab (0.3 mg, 11.1 months; 0.5 mg, 10.9 months) than sham-treated patients who crossed over to ranibizumab 0.5 mg at month 24 (35.7 months; both p<0.0001). Half of ranibizumab-treated patients achieved ≥20/40 BCVA within 2.3 (0.3 mg) and 1.9 months (0.5 mg). Baseline predictors of early vision improvement among ranibizumab-treated patients were BCVA ≤55 ETDRS letters, younger age and presence of subretinal fluid. CONCLUSION: Prompt ranibizumab therapy for DME was associated with rapid, clinically meaningful vision gains that were maintained over 36 months of treatment. Lower BCVA, younger age and presence of subretinal fluid were predictive of early vision improvement.