1. Efficacy of ranibizumab in patients with macular edema secondary to central retinal vein occlusion: results from the sham-controlled ROCC study.
- Author
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Kinge B, Stordahl PB, Forsaa V, Fossen K, Haugstad M, Helgesen OH, Seland J, and Stene-Johansen I
- Subjects
- Aged, Aged, 80 and over, Angiogenesis Inhibitors adverse effects, Antibodies, Monoclonal adverse effects, Antibodies, Monoclonal, Humanized, Double-Blind Method, Female, Follow-Up Studies, Humans, Injections, Macular Edema etiology, Macular Edema physiopathology, Male, Middle Aged, Prospective Studies, Ranibizumab, Retinal Vein Occlusion complications, Retinal Vein Occlusion physiopathology, Retreatment, Treatment Outcome, Visual Acuity physiology, Vitreous Body, Angiogenesis Inhibitors administration & dosage, Antibodies, Monoclonal administration & dosage, Macular Edema drug therapy, Retinal Vein Occlusion drug therapy
- Abstract
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 microm in the ranibizumab group and -86 +/- 165 microm 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 microm with ranibizumab and -151 +/- 205 microm 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., (Copyright (c) 2010 Elsevier Inc. All rights reserved.)
- Published
- 2010
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