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David M Brown, VISTA-DME and VIVID-DME study investigators; Intravitreal Aflibercept Injection (IAI) for Diabetic Macular Edema (DME): Primary and Additional Endpoint Results from the 12-Month Phase 3 VISTA-DME and VIVID-DME Studies. Invest. Ophthalmol. Vis. Sci. 2014;55(13):5052.
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To compare the efficacy and safety of IAI with macular laser photocoagulation for the treatment of DME.
VISTA-DME and VIVID-DME were two similarly designed, double-masked, phase 3 trials that randomized 466 and 406 DME patients, respectively, to receive either IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks (2q8, following 5 initial monthly doses), or laser. The primary efficacy endpoint was the mean change from baseline in best corrected visual acuity (BCVA) at week 52.
The mean BCVA gain from baseline to week 52 in the 2q4 and 2q8 groups vs the laser group was 12.5 and 10.7 vs 0.2 letters (P<.0001) in VISTA-DME, and 10.5 and 10.7 vs 1.2 letters (P<.0001) in VIVID-DME, respectively. The proportion of patients who gained ≥15 letters from baseline to week 52 in the 2q4 and 2q8 groups vs the laser group was 41.6% and 31.1% vs 7.8% (P<.0001) in VISTA-DME, and 32.4% and 33.3% vs 9.1% (P<.0001) in VIVID-DME, respectively. The corresponding percentage of patients who lost ≥15 letters was 0.6% and 0.7% vs 9.1% in VISTA, and 0.7% and 0% vs 10.6% in VIVID, respectively. The proportion of 2q4 and 2q8 patients vs laser patients who had a ≥2-step improvement in the Diabetic Retinopathy Severity Scale score was 33.8% and 29.1% vs 14.3% (P<.01) in VISTA, and 33.3% and 27.7% vs 7.5% (P<.001) in VIVID. The mean reduction in central retinal thickness from baseline to week 52 in the 2q4 and 2q8 groups vs the laser group was 185.9 and 183.1 vs 73.3 µm (P<.0001) in VISTA, and 195.0 and 192.4 vs 66.2 µm (P<.0001) in VIVID. The most frequent ocular adverse events (AEs) included conjunctival hemorrhage, eye pain, and vitreous floaters. The overall incidence of ocular and non-ocular AEs and serious AEs, including the Anti-Platelet Trialists’ Collaboration-defined arterial thromboembolic events, was similar across treatment groups.
In both VISTA-DME and VIVID-DME, intravitreal aflibercept groups demonstrated significant and robust superiority in all visual and anatomic endpoints over laser at week 52, with similar efficacy in the 2q4 and 2q8 treatment groups. IAI was generally well tolerated with no systemic safety signals evident through week 52, and no overall difference between treatment groups in serious systemic adverse events, including APTC events.
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