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

David M. Brown, Peter A Campochiaro, Rishi P. Singh, Zhengrong Li, Sarah Gray, Namrata Saroj, Amy Chen Rundle, Roman G. Rubio, Wendy Yee Murahashi

Research output: Contribution to journalArticle

Abstract

Purpose: To assess the efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema after central retinal vein occlusion (CRVO). Design: Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial. Participants: A total of 392 patients with macular edema after CRVO. Methods: Eligible patients were randomized 1:1:1 to receive monthly intraocular injections of 0.3 or 0.5 mg of ranibizumab or sham injections. Main Outcome Measures: 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). Results: Mean (95% confidence interval [CI]) change from baseline BCVA letter score at month 6 was 12.7 (9.9-15.4) and 14.9 (12.6-17.2) in the 0.3 mg and 0.5 mg ranibizumab groups, respectively, and 0.8 (-2.0 to 3.6) in the sham group (P

Original languageEnglish (US)
JournalOphthalmology
Volume117
Issue number6
DOIs
StatePublished - Jun 2010

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Retinal Vein
Retinal Vein Occlusion
Macular Edema
Intraocular Injections
Visual Acuity
Outcome Assessment (Health Care)
Injections
Multicenter Studies
Clinical Trials
Confidence Intervals
Safety
Ranibizumab

ASJC Scopus subject areas

  • Ophthalmology

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Ranibizumab for Macular Edema following Central Retinal Vein Occlusion. Six-Month Primary End Point Results of a Phase III Study. / Brown, David M.; Campochiaro, Peter A; Singh, Rishi P.; Li, Zhengrong; Gray, Sarah; Saroj, Namrata; Rundle, Amy Chen; Rubio, Roman G.; Murahashi, Wendy Yee.

In: Ophthalmology, Vol. 117, No. 6, 06.2010.

Research output: Contribution to journalArticle

Brown, David M. ; Campochiaro, Peter A ; Singh, Rishi P. ; Li, Zhengrong ; Gray, Sarah ; Saroj, Namrata ; Rundle, Amy Chen ; Rubio, Roman G. ; Murahashi, Wendy Yee. / Ranibizumab for Macular Edema following Central Retinal Vein Occlusion. Six-Month Primary End Point Results of a Phase III Study. In: Ophthalmology. 2010 ; Vol. 117, No. 6.
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