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Characterization of Vascular Morphology of Neovascular Age-Related Macular Degeneration by Indocyanine Green Angiography
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Cerebrovascular accidents in patients treated for choroidal neovascularization with ranibizumab in randomized

Neil M Bressler1, David S Boyer, David F Williams

  • 1Retina Division, Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287, USA. nmboffice@jhmi.edu

Retina (Philadelphia, Pa.)
|September 27, 2012
PubMed
Abstract

Insights

Ranibizumab treatment for age-related macular degeneration may slightly increase stroke risk, particularly at higher doses. Further monitoring in clinical trials is recommended for cerebrovascular accidents (CVAs).

Area of Science:

  • Ophthalmology
  • Neurology
  • Clinical Trials

Background:

  • Neovascular age-related macular degeneration (AMD) is a leading cause of vision loss.
  • Ranibizumab is a common treatment for wet AMD.
  • Cerebrovascular accidents (CVAs) are a potential safety concern for systemic drug treatments.

Purpose of the Study:

  • To analyze cerebrovascular accident (CVA) rates in patients treated with ranibizumab for neovascular AMD.
  • To assess the safety profile of ranibizumab concerning CVA risk across multiple clinical trials.

Main Methods:

  • Pooled data from five large, randomized, controlled trials (FOCUS, MARINA, ANCHOR, PIER, SAILOR).
  • Standard safety monitoring and statistical analysis, including exact methods and logistic regression for risk stratification.
  • Evaluation of CVA rates at 1- and 2-year follow-ups within different risk groups.

Main Results:

  • Pooled 2-year CVA rates were below 3%.
  • Ranibizumab 0.5 mg showed a potential increased odds ratio for CVA compared to control (2.2 [0.8-7.1]) and 0.3 mg (1.5 [0.8-3.0]).
  • A larger difference in CVA rates was observed between 0.5-mg ranibizumab and control among high-risk patients.

Conclusions:

  • Evidence suggests a potential, though not definitive, increased risk of CVA with ranibizumab, especially the 0.5-mg dose.
  • The risk appears more pronounced in patients with pre-existing CVA risk factors.
  • Continued safety monitoring for CVAs in ranibizumab clinical trials is warranted.

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