Ranibizumab injection for diabetic macular edema: meta-analysis of systemic safety and systematic review

Can J Ophthalmol. 2013 Aug;48(4):317-23. doi: 10.1016/j.jcjo.2013.03.004.

Abstract

Objective: To conduct a systematic review on the safety of ranibizumab injections for diabetic macular edema by meta-analysis of recently conducted level 1 randomized clinical trials.

Design: A meta-analysis and systematic review.

Methods: Main outcome measures of permissible studies were extracted and reported. The relative risk (RR) for thromboembolic events (TEEs) was calculated for those studies that met this study's inclusion criteria. The fixed-effects model (Mantel-Haenszel method) was appropriately used to calculate the pooled RR. The quality of trials was assessed using the Jadad score.

Results: Of the 2072 patients who were included from 5 [corrected] eligible randomized clinical trials, 1295 patients received intravitreal ranibizumab injections. The pooled RR for TEEs after ranibizumab intravitreal injection was 0.74 (95% CI 0.52-1.06).

Conclusions: Intravitreal ranibizumab for the treatment of diabetic macular edema did not increase the risk for TEEs as shown by this meta-analysis of 4 randomized, controlled clinical trials.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Angiogenesis Inhibitors / adverse effects*
  • Angiogenesis Inhibitors / therapeutic use
  • Antibodies, Monoclonal, Humanized / adverse effects*
  • Antibodies, Monoclonal, Humanized / therapeutic use
  • Diabetic Retinopathy / drug therapy*
  • Female
  • Humans
  • Intravitreal Injections
  • Macular Edema / drug therapy*
  • Male
  • Middle Aged
  • Randomized Controlled Trials as Topic
  • Ranibizumab
  • Risk Assessment
  • Thromboembolism / chemically induced
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors

Substances

  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal, Humanized
  • VEGFA protein, human
  • Vascular Endothelial Growth Factor A
  • Ranibizumab