Vascular Safety Profile of Ranibizumab

Journal Highlights

Ophthalmology Retina, November 2018

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Intravitreal anti–vascular endothelial growth factor (VEGF) drugs carry an increased risk of systemic events, including those of a cardiovascular and cerebrovascular nature. Zarbin et al. set out to evaluate the vascular safety profile of ranibizumab 0.5 mg relative to sham treatment, with or without verteporfin, in patients with neovascu­lar age-related macular degeneration (AMD). In addition, they compared ranibizumab 0.3 mg to sham and 0.3 mg to 0.5 mg of ranibizumab. They found low rates of vascular events in these patients overall and no clini­cally meaningful differences between patients treated with ranibizumab and those treated with sham or verteporfin.

For this study, researchers evaluated data from 7 randomized trials (phases 2-4). The pooled dataset comprised 4,080 patients with wet AMD. Of these, 1,764 patients were treated with ranibi­zumab 0.3 mg, and 1,854 were treated with ranibizumab 0.5 mg. Relevant safety endpoints included arterial thromboembolic events (ATEs), myo­cardial infarction (MI), stroke, transient ischemic attacks (TIAs), and vascular deaths. Pairwise comparisons for ran­ibizumab 0.5 mg (the globally approved dosage for wet AMD) and sham or verteporfin were performed using Cox proportional hazard regression and rates per 100 patient-years.

Hazard ratios (95% confidence intervals) included 1, indicating no significant treatment differences, for all endpoints, between ranibizumab 0.5 mg and sham or verteporfin. Although this supports the established risk-benefit profile of ranibizumab in patients with neovascular AMD, the authors noted that extrapolating these findings to the real-world population is limited by the enrollment criteria of the selected stud­ies—and that more data are needed on the systemic safety of anti-VEGF drugs in clinical practice.

The original article can be found here.