Ranibizumab for diabetic macular edema: Results from 2 phase iii randomized trials: RISE and RIDE

Elsevier, Ophthalmology, Volume 119, April 2012
Nguyen Q.D., Brown D.M., Marcus D.M., Boyer D.S., Patel S., Feiner L. et al.
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 injectioncontrolled, randomized studies. Participants: Adults with vision loss from DME (best-corrected visual acuity [BCVA], 20/4020/320 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-protocolspecified 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