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Robert Avery, Steven Francom, Phillip Lai, Chad Melson, Sung Cha, Lisa Tuomi; Meta-analysis examining the systemic safety profile of intravitreal ranibizumab injections in AMD, RVO and DME. Invest. Ophthalmol. Vis. Sci. 2013;54(15):1535.
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Intravitreal ranibizumab is used to treat age-related macular degeneration (AMD), retinal vein occlusion (RVO) and diabetic macular edema (DME), with patient exposure exceeding 1.2 million treatment-years since 2006. The purpose of this meta-analysis is to better characterize the safety profiles of 0.3mg and 0.5mg ranibizumab versus sham using a database containing Genentech and Novartis Phase II, III and IIIb clinical trials.
The pooled safety database includes 22 studies and 10,300 patients (mean follow-up time 15.9 mo; maximum, 64.2 mo; Table 2) and incorporates patient-level dosing information (drug exposure), demographics, key baseline risk factors, and timing of events relative to study initiation. All available adverse event information on individual patients from time of randomization/enrollment to last evaluation was included. Event rates were evaluated by indication (AMD, RVO, and DME). Pairwise treatment comparisons (0.5mg vs control [sham/PDT], 0.3mg vs control, and 0.5mg vs 0.3mg) were performed for studies where both treatment arms were evaluated (Table 1).
Pairwise comparisons in DME for 0.5mg vs control showed higher rates of death (1.6 vs 0.7, per 100 patient-years [pt-yrs]) and wound healing complications (1.6 vs 0, per 100 pt-yrs); for 0.3mg vs control, a higher rate of death (1.6 vs 0.7, per 100 pt-yrs); and for 0.5mg vs 0.3mg, higher rates of death (2.4 vs 1.6, per 100 pt-yrs), stroke (2.0 vs 0.7, per 100 pt-yrs) and wound healing complications (1.3 vs 0.5, per 100 pt-yrs). These imbalances were not seen in AMD or RVO patients. No rate imbalances were seen in any indication for other key systemic events including myocardial infarction, cardiovascular events, hemorrhage, gastrointestinal perforation, hypertension and proteinuria.
This meta-analysis represents the largest comprehensive evaluation of ranibizumab safety data to date. These data indicate a safety profile consistent with the previously-reported safety profile of ranibizumab from individual randomized, controlled clinical trials; however, the results of any meta-analyses should be interpreted with caution due to their inherent limitations.
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