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John William Kitchens; Systematic Review of Safety Across the Phase 2 and 3 Clinical Trials of Intravitreal Aflibercept Injection in Neovascular Age-Related Macular Degeneration, Macular Edema Following Retinal Vein Occlusion, and Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4606.
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© ARVO (1962-2015); The Authors (2016-present)
Systematic Review of Safety Across the Phase 2 and 3 Clinical Trials of Intravitreal Aflibercept Injection in Neovascular AMD, Macular Edema Following RVO, and DME To assess the systemic and ocular safety of intravitreal aflibercept injection (IAI) compared to control in trials evaluating efficacy and safety of IAI in neovascular AMD, macular edema (ME) following BRVO and CRVO, and DME. Outcomes included intraocular inflammation (IOI) endophthalmitis, hypertension (HTN), and adjudicated Antiplatelet Trialists’ Collaboration-defined arterial thromboembolic events (APTC-ATEs).
Patients were included from 10 phase 2/3 trials evaluating IAI in: AMD (CLEAR-IT 2 [52 weeks], VIEW 1, VIEW 2 [96 weeks], VIEW 1 extension [208 weeks]); ME following BRVO (VIBRANT [52 weeks]); ME following CRVO (COPERNICUS [100 weeks], GALILEO [76 weeks]); DME (DA VINCI [52 weeks], VIVID, VISTA [100 weeks]). Analyses are based on rates calculated as events per 100 person-years at risk (PYR).
Over 4000 patients contributed over 7000 PYR. Age ranged from 22 (ME following CRVO) to 99 (AMD). For all outcomes, there were no meaningful differences between rates for comparators and IAI or between IAI fixed and alternative dosing. Overall IOI rates were 2.40 (control) and 2.05 (IAI); overall rates ratio was 0.85 (0.60, 1.23). Overall endophthalmitis rates were 0.52 (control) and 0.22 (IAI); overall rates ratio was 0.43 (0.18, 1.05). Overall HTN rates were 14.80 (controls) and 11.27 (IAI), with an overall rates ratio of 0.76 (0.65, 0.89); HTN rates were highest in ME following BRVO and lowest in AMD. For adjudicated APTC-ATEs, rates were 2.02 (controls) and 2.19 (IAI) with a rates ratio of 1.09 (0.74, 1.63); highest rates were observed in DME and lowest in ME following CRVO.
Overall rates of selected ocular/non-ocular adverse events with IAI fixed/alternative dosing regimens were similar to controls in all evaluated IAI trials, now including additional data from extended follow-up in VIEW 1 extension, VIBRANT, and VISTA/VIVID. IAI was generally well tolerated in the evaluated studies compared to controls.
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