• Quan Dong Nguyen, David M Brown, Dennis M Marcus, David S Boyer, Sunil Patel, Leonard Feiner, Andrea Gibson, Judy Sy, Amy Chen Rundle, J Jill Hopkins, Roman G Rubio, Jason S Ehrlich, and RISE and RIDE Research Group.
• Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
• Ophthalmology. 2012 Apr 1; 119 (4): 789-801.

PurposeTo evaluate the efficacy and safety of intravitreal ranibizumab in diabetic macular edema (DME) patients.DesignTwo parallel, methodologically identical, phase III, multicenter, double-masked, sham injection-controlled, randomized studies.ParticipantsAdults 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).InterventionMonthly intravitreal ranibizumab (0.5 or 0.3 mg) or sham injections. Macular laser was available per-protocol-specified criteria.Main Outcome MeasuresProportion of patients gaining ≥15 letters in BCVA from baseline at 24 months.ResultsIn 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<0.0001; difference vs sham adjusted for randomization stratification factors, 24.3%; 95% confidence interval [CI], 13.8-34.8) and 39.2% of 0.5-mg ranibizumab patients (P<0.001; adjusted difference, 20.9%; 95% CI, 10.7-31.1). In RIDE (NCT00473382), 382 patients were randomized (130 to sham, 125 to 0.3 mg, 127 to 0.5 mg). Significantly more ranibizumab-treated patients gained ≥15 letters: 12.3% of sham patients versus 33.6% of 0.3-mg patients (P<0.0001; adjusted difference, 20.8%; 95% CI, 11.4-30.2) and 45.7% of 0.5-mg ranibizumab patients (P<0.0001; adjusted difference, 33.3%; 95% CI, 23.8-42.8). Significant improvements in macular edema were noted on OCT, and retinopathy was less likely to worsen and more likely to improve in ranibizumab-treated patients. Ranibizumab-treated patients underwent significantly fewer macular laser procedures (mean of 1.8 and 1.6 laser procedures over 24 months in the sham groups vs 0.3-0.8 in ranibizumab groups). Ocular safety was consistent with prior ranibizumab studies; endophthalmitis occurred in 4 ranibizumab patients. The total incidence of deaths from vascular or unknown causes, nonfatal myocardial infarctions, and nonfatal cerebrovascular accidents, which are possible effects from systemic vascular endothelial growth factor inhibition, was 4.9% to 5.5% of sham patients and 2.4% to 8.8% of ranibizumab patients.ConclusionsRanibizumab 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.Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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