Intravitreal Aflibercept (IVT‐AFL) for Diabetic Macular Edema (DME): 3 Year Data from VIVID‐DME and VISTA‐DME

Abstract

PurposeTo evaluate long‐term outcomes with IVT‐AFL injection in the treatment of DME.Methods406 patients (VIVID‐DME) and 466 patients (VISTA‐DME) were randomized to IVT‐AFL 2 mg every 4 weeks + sham laser (2q4), IVT‐AFL 2 mg every 8 weeks (after 5 initial monthly doses) + sham laser (2q8), or laser + sham injections. From week (W)100 to W148, laser patients could receive IVT‐AFL if retreatment criteria were met. Primary efficacy endpoint was the mean change from baseline (BL) in best corrected visual acuity (BCVA) at W52. Outcomes at W100 and W148 are described.ResultsAt W100, mean BCVA gains from BL in the IVT‐AFL 2q4, 2q8 and laser groups were +11.4, +9.4 and +0.7 letters (VIVID‐DME; P < 0.0001), and +11.5, +11.1 and +0.9 letters (VISTA‐DME; P < 0.0001). In VISTA‐DME, improvements in BCVA were maintained to W148 in the IVT‐AFL 2q4 (+10.4 letters) and 2q8 (+10.5 letters) groups. Cataract was the most frequent ocular serious AE in both studies through 100 weeks (VIVID‐DME: 2.2%; VISTA‐DME: 1.3%); incidence of Antiplatelet Trialists’ Collaboration‐defined arterial thromboembolic events with IVT‐AFL was similar across the studies (VIVID‐DME: 4.8%; VISTA‐DME: 7.8%). Safety outcomes at W148 in VISTA‐DME were consistent with W100 data with no new safety signals observed. The third year of VIVID‐DME is ongoing.ConclusionsIn both studies, IVT‐AFL demonstrated superior outcomes compared with laser through W100, with similar efficacy in the 2q4 and 2q8 groups. In VISTA‐DME, BCVA gains from BL with both IVT‐AFL regimens were sustained through W148. Through 100 weeks the incidence of AEs was consistent with the known safety profile of IVT‐AFL.