September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Patient-level Meta-analysis of the Safety of Bevacizumab vs Ranibizumab in International Randomized Clinical Trials for the Treatment of Neovascular Age-Related Macular Degeneration
Author Affiliations & Notes
  • James A Shaffer
    Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania, United States
  • Footnotes
    Commercial Relationships   James Shaffer, None
  • Footnotes
    Support  U10EY017823, R21EY023689
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 3338. doi:
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    • Get Citation

      James A Shaffer; Patient-level Meta-analysis of the Safety of Bevacizumab vs Ranibizumab in International Randomized Clinical Trials for the Treatment of Neovascular Age-Related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3338.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To compare systemic serious adverse events (SAE) between bevacizumab and ranibizumab by combining patient-level data from international randomized clinical trials of ranibizumab vs bevacizumab for treatment of neovascular age-related macular degeneration (nAMD).

Methods : Patient-level data were obtained from 5 randomized clinical trials (Comparison of Age-related Macular Degeneration Treatments Trials [CATT], French Study Group Avastin versus Lucentis for neovascular AMD [GEFAL], Inhibit VEGF in Age-related Choroidal Neovascularization [IVAN], Lucentis Compared to Avastin Study [LUCAS], and Bevacizumab and Ranibizumab in Age-related Macular Degeneration [BRAMD].) For each trial, Cox proportional hazard models were used to calculate crude and covariate-adjusted hazard ratios (HRs) for comparing SAEs in the bevacizumab group to the ranibizumab group. Covariates included age, gender, dosing regimen, smoking status, diabetes, hypertension, and anti-coagulant use. Random effects models were then used to summarize the trial-specific HR estimates into pooled HR estimates and their 95% confidence intervals (CIs). Comparisons were performed for death, any SAE, arterial thrombotic SAE, SAE related to anti-VEGF drugs, and SAE not related to anti-VEGF drugs.

Results : The analysis included 3,052 participants (1,513 treated with bevacizumab; 1,539 treated with ranibizumab). There were 58 patients who died in each drug group (HR=0.99 for bevacizumab relative to ranibizumab; 95% CI: 0.69-1.43). The SAE rate was 26.6% in the bevacizumab group and 23.8% in the ranibizumab group, and the difference was not significant (HR=1.06, 95% CI: 0.84 – 1.35). Similarly, there was no statistically significant differences in arterial thrombotic SAE (HR= 0.89; 95% CI: 0.62-1.28), SAEs previously associated with use of anti-VEGF agents (HR=1.10; 95%CI: 0.81, 1.50), or SAEs not previously associated with use of anti-VEGF drugs (HR=1.11; 95%CI: 0.87, 1.40).

Conclusions : Consistent with previous study-level meta-analyses, in our patient-level meta-analysis with adjustment for baseline covariates, we found no evidence of differences in the systemic safety between bevacizumab and ranibizumab after intravitreal treatment for neovascular age-related macular degeneration.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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