Efficacy of Ranibizumab in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion: Results From the Sham-Controlled ROCC Study

Purpose

The ROCC study (randomized study comparing ranibizumab to sham in patients with macular edema secondary to central Retinal vein OCClusion [CRVO]) evaluated the short-term effect of intravitreal ranibizumab injections on best-corrected visual acuity (BCVA) and macular edema.

Design

Prospective, multicenter, randomized, double-masked, placebo-controlled trial.

Methods

In this 6-month trial, 32 patients with macular edema secondary to CRVO were randomized to receive monthly intravitreal ranibizumab (0.5 mg/0.05 mL) or sham injections for 3 consecutive months. If macular edema persisted, patients received further monthly injections. Primary outcome measures were BCVA and central macular thickness (CMT) at 6 months.

Results

Twenty-nine patients completed the study. After 3 months, BCVA improved by a mean ± standard deviation (SD) of 16 ± 14 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the ranibizumab group (n = 15), compared with a mean loss of 5 ± 15 ETDRS letters in the sham group (n = 14; P = .001). The mean ± SD change in CMT was −411 ± 200 μm in the ranibizumab group and −86 ± 165 μm with sham (P < .001). At 6 months, the mean ± SD change in BCVA was 12 ± 20 ETDRS letters in the ranibizumab group compared with −1 ± 17 ETDRS letters in the sham group (P = .067). The mean ± SD change in CMT was −304 ± 194 μm with ranibizumab and −151 ± 205 μm with sham (P = .05). Twelve patients (80%) in the ranibizumab group required more than 3 initial injections; mean ± SD number of injections was 4.3 ± 0.9 during the study.

Conclusion

Monthly ranibizumab significantly increased BCVA and decreased macular edema, compared with sham, in patients with CRVO. Repeated consecutive injections are necessary to maintain initial positive results.