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Diana V Do; Intravitreal Aflibercept Injection (IAI) for Diabetic Macular Edema (DME): 148-Week Results from VISTA and VIVID. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2081.
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© ARVO (1962-2015); The Authors (2016-present)
To compare efficacy and safety of IAI with macular laser photocoagulation in DME.
VISTA and VIVID were two similarly designed phase 3 trials that treated 461 and 404 DME patients, respectively, with IAI 2 mg q4 weeks (2q4), IAI 2 mg q8 weeks following 5 monthly doses (2q8), or laser control with monthly follow-up through week 148. Starting at week 24, if rescue treatment criteria were met, IAI patients received active laser, and laser control patients received IAI 2q8. Beginning at week 100, patients in the laser control group who had not already qualified for IAI rescue treatment received IAI as needed per retreatment criteria. The primary efficacy endpoint was mean change from baseline in best-corrected visual acuity (BCVA) at week 52.
At week 52, mean BCVA gains from baseline in the 2q4, 2q8, and laser control groups were 12.5, 10.7, and 0.2 letters (P<.0001) in VISTA, and 10.5, 10.7, and 1.2 letters (P<.0001) in VIVID, respectively. At week 100, the corresponding gains were 11.5, 11.1, and 0.9 letters (P<.0001) In VISTA, and 11.4, 9.3, and 0.7 letters (P<.0001) in VIVID, respectively. At week 148, the corresponding gains were 10.4, 10.5, and 1.4 letters (P<.0001) in VISTA, and 10.3, 11.7, and 1.6 letters (P<.0001) in VIVID, respectively. When measurements after rescue treatment was given were included in the analysis, mean BCVA gains from baseline to week 148 were 10.5, 11.2, and 8.2 letters (P<.05 for 2q8) in VISTA, and 11.2 and 12.9, and 7.0 letters (P<.01) in VIVID, respectively. Over 148 weeks, cataract was the most frequent ocular SAE with IAI in both studies: VISTA, 1.3%; VIVID, 4.1%. The frequency of APTC-defined arterial thromboembolic events with IAI was similar across studies: VISTA, 10.4%; VIVID, 7.0%.
BCVA gains observed with both IAI regimens (over control) at weeks 52 and 100 were maintained at week 148, with similar efficacy in the 2q4 and 2q8 groups. Over 148 weeks, the incidence of adverse events was consistent with the known safety profile of IAI.
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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