, Ophthalmology, Volume 119, April 2012
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.