Cerebrovascular accidents in patients treated for choroidal neovascularization with ranibizumab in randomized controlled trials

Neil M. Bressler, David S. Boyer, David F. Williams, Steven Butler, Steven F. Francom, Benton Brown, Flavia Di Nucci, Timothy Cramm, Lisa L. Tuomi, Tsontcho Ianchulev, Roman G. Rubio

Research output: Contribution to journalArticlepeer-review

Abstract

PURPOSE: To analyze cerebrovascular accidents (CVAs) pooled from large, randomized, controlled clinical trials of ranibizumab treatment for neovascular age-related macular degeneration. METHODS: Events in five trials (FOCUS, MARINA, ANCHOR, PIER, and SAILOR) were analyzed using a standard safety monitoring process. Exact methods, stratified by study, were used to test for treatment differences based on odds ratios. A stepwise logistic regression model was fit to classify subjects' risk for CVA based on medical history. Treatment differences in CVA rates at 1 year or 2 years were evaluated within risk groups using stratified exact methods. RESULTS: Pooled 2-year CVA rates were <3%; odds ratios (95% confidence intervals) for CVA risk were 1.2 (0.4-4.4) for ranibizumab 0.3-mg versus control, 2.2 (0.8-7.1) for 0.5 mg versus control, and 1.5 (0.8-3.0) for 0.5-mg versus 0.3-mg ranibizumab. No substantial increased risk of CVA for 0.5 mg versus 0.3 mg was identified in pooled analyses or any of the individual trials. In pooled analyses, the difference between 0.5-mg ranibizumab and control was larger (7.7 [1.2-177]) among high-risk CVA patients. CONCLUSION: This analysis provided some evidence, although not definitive, of a potential increased risk of CVA with ranibizumab versus control or with 0.5-mg versus 0.3-mg ranibizumab. Continued monitoring for CVA within clinical trials seems warrented.

Original languageEnglish (US)
Pages (from-to)1821-1828
Number of pages8
JournalRetina
Volume32
Issue number9
DOIs
StatePublished - Oct 2012

ASJC Scopus subject areas

  • Ophthalmology

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