Ranibizumab for Macular Edema following Branch Retinal Vein Occlusion: Six-Month Primary End Point Results of a Phase III Study

To assess efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema following branch retinal vein occlusion (BRVO). Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial. A total of 397 patients with macular e...

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Veröffentlicht in:Ophthalmology (Rochester, Minn.) Minn.), 2010-06, Vol.117 (6), p.1102-1112
Hauptverfasser: CAMPOCHIARO, Peter A, HEIER, Jeffrey S, FEINER, Leonard, GRAY, Sarah, SAROJ, Namrata, RUNDLE, Amy Chen, YEE MURAHASHI, Wendy, RUBIO, Roman G
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Sprache:eng
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Zusammenfassung:To assess efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema following branch retinal vein occlusion (BRVO). Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial. A total of 397 patients with macular edema following BRVO. Eligible patients were randomized 1:1:1 to receive monthly intraocular injections of 0.3 mg or 0.5 mg of ranibizumab or sham injections. The primary efficacy outcome measure was mean change from baseline best-corrected visual acuity (BCVA) letter score at month 6. Secondary outcomes included other parameters of visual function and central foveal thickness (CFT). Mean (95% confidence interval [CI]) change from baseline BCVA letter score at month 6 was 16.6 (14.7-18.5) and 18.3 (16.0-20.6) in the 0.3 mg and 0.5 mg ranibizumab groups and 7.3 (5.1-9.5) in the sham group (P or =15 letters in BCVA at month 6 was 55.2% (0.3 mg) and 61.1% (0.5 mg) in the ranibizumab groups and 28.8% in the sham group (P or =20/40 compared with sham patients (41.7%; P
ISSN:0161-6420
1549-4713
DOI:10.1016/j.ophtha.2010.02.021