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Intravitreal Aflibercept ( IVT ‐ AFL ) for Diabetic Macular Edema ( DME ): 3 Year Data from VIVID ‐ DME and VISTA ‐ DME
Author(s) -
Staurenghi G.,
Metzig C.
Publication year - 2015
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2015.0600
Subject(s) - diabetic macular edema , medicine , ophthalmology , aflibercept , visual acuity , clinical endpoint , surgery , diabetic retinopathy , randomized controlled trial , diabetes mellitus , bevacizumab , endocrinology , chemotherapy
Purpose To evaluate long‐term outcomes with IVT ‐ AFL injection in the treatment of DME . Methods 406 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. Results At 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. Conclusions In 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 AE s was consistent with the known safety profile of IVT ‐ AFL .