Ranibizumab for Diabetic Macular Edema

Purpose To evaluate the efficacy and safety of intravitreal ranibizumab in diabetic macular edema (DME) patients. Design Two parallel, methodologically identical, phase III, multicenter, double-masked, sham injection-controlled, randomized studies. Participants Adults with vision loss from DME (best-corrected visual acuity [BCVA], 20/40-20/320 Snellen equivalent) and central subfield thickness ≥275 μm on time-domain optical coherence tomography (OCT). Intervention Monthly intravitreal ranibizumab (0.5 or 0.3 mg) or sham injections. Macular laser was available per-protocol-specified criteria. Main outcome measures Proportion of patients gaining ≥15 letters in BCVA from baseline at 24 months. Results In RISE (NCT00473330), 377 patients were randomized (127 to sham, 125 to 0.3 mg, 125 to 0.5 mg). At 24 months, 18.1% of sham patients gained ≥15 letters versus 44.8% of 0.3-mg (P Conclusions Ranibizumab rapidly and sustainably improved vision, reduced the risk of further vision loss, and improved macular edema in patients with DME, with low rates of ocular and nonocular harm.