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Study: Systemic vascular risk higher with intensive treatment with ranibizumab for AMD
However, there is no apparent impact on the risk of mortality.
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An intravitreal dose of ranibizumab for treatment of age-related macular degeneration is small, but it can affect systemic vasculature, according to one study author.
“Many ophthalmologists do not realize the possible increase in the systemic vascular risks by injecting ranibizumab for AMD. I assume this is because the frequency of [cerebrovascular accidents] and other systemic vascular adverse events is low — usually up to several percentages of AMD patients per year,” Takashi Ueta, MD, PhD, principal investigator, told Ocular Surgery News. “However, our meta-analysis, by including data for more than 6,500 patients, showed significant increase in the risk of CVA and non-ocular hemorrhage.”
Updated data
The meta-analysis of 11 randomized trials comprising 6,596 patients with AMD built upon a 2009 study by Ueta and colleagues that found an incidence of cerebrovascular accidents (CVAs) that was greater for monthly injections of 0.3 mg or 0.5 mg Lucentis (ranibizumab, Genentech) compared with sham injections or verteporfin photodynamic therapy. The MARINA, ANCHOR and FOCUS studies were included in the 2009 analysis.
The current meta-analysis found a significant 86% increase in odds ratio for CVAs with a 0.5 mg injection of ranibizumab vs. combining the 0.3 mg ranibizumab and no ranibizumab groups. Similarly, there was an 89% increase in odds ratio with monthly injections of any dose compared with combining the as-needed ranibizumab and no ranibizumab groups.
The study also found there was a 57% increase in odds ratio for non-ocular hemorrhage in any dose or frequency of ranibizumab.
More cerebrovascular accidents
The authors speculated that the increased number of CVAs, without an accompanying increase in myocardial infractions, might be due to the “anatomic closeness of the vitreous cavity to the subarachnoid space.”
The study found insignificant increases of CVAs for a 0.5 mg injection of ranibizumab compared with 0.0 mg, 0.5 mg compared with 0.3 mg, and monthly treatments compared with as needed.
The study also found that ranibizumab treatment for AMD did not affect the overall risk of mortality.
Ueta said that although anti-VEGF therapy is important for the treatment of ocular disorders, being aware of the risk profile of AMD patients while scheduling the dose and frequency of ranibizumab “could reduce the likelihood of systemic vascular adverse events. For example, recent history of CVA and uncontrolled hypertension are the top risk factors for CVA.”
The authors acknowledged several limitations of their meta-analysis, including variations among as-needed treatment regimens and differences in follow-up periods. In addition, only one of the 11 studies was independent of support from a drug manufacturer or a conflict of interest. – by Bob Kronemyer
References:
Ueta T, et al. Ophthalmology. 2009;doi:10.1016/j.ophtha.2008.09.046.
Ueta T, et al. Ophthalmology. 2014;doi:10.1016/j.ophtha.2014.05.022.