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Yasuko Yanagida, Takuhiro Yamaguchi, Takashi Ueta, ; Evaluation of systemic safety by intravitreal injections of vascular endothelial growth factor inhibitors for diabetic macular edema: systematic review of literature and meta-analysis. Invest. Ophthalmol. Vis. Sci. 2013;54(15):2440.
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To evaluate whether intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors for diabetic macular edema (DME) affect the systemic vascular and mortality risk.
According to a recent review conducted by American Academy of Ophthalmology (AAO), high quality randomized controlled trials (RCTs) on ranibizumab for DME were chosen based on the predefined criteria including enrolling a minimum of 100 participants, with follow-up for at least one year, and completion rate of at least 80%. The number of events in cerebrovascular accidents (CVAs), myocardial infarction (MI) and death were extracted from the reports of the RCTs. Meta-analysis by fixed effect model was conducted due to insignificant heterogeneity among the included studies.
After screening of the corresponding abstracts and full text papers, four trials totalling 1786 patients with DME were included. In all the four RCTs, patients with recent systemic vascular events were not included. In two RCTs ranibizumab was administered monthly for two years, and in the other two RCTs as needed for one year. In patients treated with 0.3 mg/0.5 mg ranibizumab, the risk ratios (RR) and 95% confidence interval (CI) for CVA, MI and total death compared to the control groups were 0.640 (0.313-1.310, P=0.222), 0.785 (0.371-1.659, P=0.526), and 1.461(0.696-3.065, P=0.316).
Intravitreal injections of VEGF inhibitors for DME were not associated with the increased risk of CVA, MI or mortality, although data on systemic safety for high risk patients has been remained unknown.
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