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David M. Brown, Quan D. Nguyen, Roman G. Rubio, Andrea Gibson, Jill Hopkins, Judy Sy, Amy Chen Rundle, Jason S. Ehrlich, RIDE/RISE Study Group; Ranibizumab for Diabetic Macular Edema (DME): 24-Month Efficacy and Safety Results of RISE - a Phase 3 Randomized Controlled Trial. Invest. Ophthalmol. Vis. Sci. 2011;52(14):6647.
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DME is a leading cause of vision loss worldwide. Anti-VEGF therapy may provide a therapeutic benefit in both anatomic and functional endpoints. RISE (NCT00473330) and RIDE (NCT00473382), two identical, parallel Phase 3 studies, are the longest sham-controlled trials to date evaluating monthly ranibizumab (RBZ; Lucentis®) in DME patients.
In RISE, a double-masked, sham-controlled, multicenter trial, 377 patients meeting eligibility criteria (including best corrected visual acuity [BCVA] 20/40-20/320 Snellen equivalent and foveal thickness ≥275µm on optical coherence tomography [OCT]) were randomized to receive monthly RBZ (0.5mg or 0.3mg) or sham injections. Need for macular rescue laser was assessed monthly starting at Month 3. The primary efficacy outcome was the proportion of patients gaining ≥15 letters in BCVA from baseline at Month 24. Safety was assessed based on ocular and systemic adverse events (AEs).
At the primary endpoint, 44.8% and 39.2% of RBZ-treated subjects (0.3mg and 0.5mg, respectively) gained ≥15 letters, versus 18.1% of sham subjects (p<0.01 for both RBZ arms). Mean foveal thickness decreased by 250.6 to 253.1 µm in the RBZ groups, and 133.6 µm in the sham group. Ocular AEs were consistent with prior studies of RBZ. Rates of arterial thromboembolic events (ATEs) were similar in the sham and RBZ 0.5mg arms (7.3% and 7.9% respectively), and less common in the RBZ 0.3mg group (3.2%). Among ATEs, 2 strokes (1.6%) occurred in the sham group, 1 (0.8%) in RBZ 0.3mg, and 5 (4.0%) in RBZ 0.5mg.
In RISE, subjects treated monthly with RBZ for 24 months experienced early, sustained, and statistically significant improvements in BCVA and OCT compared to subjects in the sham group. The incidence of ocular AEs was consistent with prior clinical trials involving intravitreal injections. Overall rates of ATEs were similar to those reported in other studies of laser, RBZ, and/or triamcinolone in DME.
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