April 2014
Volume 55, Issue 13
ARVO Annual Meeting Abstract  |   April 2014
Systematic Review of Safety Across the Phase 2 and 3 Clinical Trials of Intravitreal Aflibercept Injection
Author Affiliations & Notes
  • Diana V Do
    Ophthalmology, Truhlsen Eye Institute, University of Nebraska, Omaha, NE
  • Footnotes
    Commercial Relationships Diana Do, Genentech (F), Regeneron (C), Regeneron (F)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 593. doi:
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      Diana V Do; Systematic Review of Safety Across the Phase 2 and 3 Clinical Trials of Intravitreal Aflibercept Injection. Invest. Ophthalmol. Vis. Sci. 2014;55(13):593.

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

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Purpose: Systematic review of safety events including intraocular inflammation (IOI) and adjudicated anti-platelet trialists’ collaboration (APTC) events from randomized, controlled clinical trials of intravitreal aflibercept injection (IAI) for 3 indications: neovascular age-related macular degeneration (AMD), macular edema following central retinal vein occlusion (CRVO), and diabetic macular edema (DME).

Methods: The safety analysis included patients from 8 phase 2 and 3 clinical trials across 3 diseases: wet AMD (CLEAR-IT 2, VIEW 1, and VIEW 2 [96 weeks]); CRVO (COPERNICUS [100 weeks], GALILEO [76 weeks]); DME (DAVINCI, VIVID, and VISTA [52 weeks]). Data were analyzed in terms of number of events/person-years at risk (PYR). Rates were calculated as events per 100 PYR. Different time periods across the trials were evaluated to account for dosing regimen and comparator variability.

Results: Over 3900 patients contributed over 5400 PYR. The rates of all events studied were low. There were no significant differences between rates for IAI and comparators or between fixed and alternative dosing. The IOI rates were 1.96 (IAI) and 3.07 (RBZ) in wet AMD, 1.134 (IAI) and 2.79 (sham) in CRVO, and 2.38 (IAI) and 1.11 (laser) in DME. For adjudicated APTC events: (a) the rates for non-fatal myocardial infarction were 0.79 (IAI) and 1.10 (RBZ) in wet AMD, 0.38 (IAI) and 0.0 (sham) in CRVO, 1.27 (IAI) and 1.85 (laser) in DME; (b) for non-fatal stroke, the rates were 0.40 (IAI) and 0.40 (RBZ) in wet AMD, 0.0 (IAI) and 0.0 (sham) in CRVO, and 1.45 (IAI) and 0.74 (laser) in DME; and (c) for vascular death, the rates were 0.63 (IAI) and 0.30 (RBZ) in wet AMD, 0.0 (IAI) and 0.92 (sham) in CRVO, and 0.72 (IAI) and 0.74 (laser) in DME.

Conclusions: Data from phase 2/3 clinical trials of IAI demonstrate that rates of selected ocular and systemic adverse events were low for both fixed and alternative IAI dosing regimens. IAI was generally well tolerated in patients in these AMD, CRVO, and DME trials.

Keywords: 412 age-related macular degeneration • 498 diabetes • 749 vascular occlusion/vascular occlusive disease  

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