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Quan Dong Nguyen, VISTA-DME/VIVID-DME Study Investigators; Impact of Prior Therapy for Diabetic Macular Edema (DME) on Visual and Anatomic Outcomes Following Treatment with Intravitreal Aflibercept: Results from the Phase 3 VISTA-DME and VIVID-DME Studies. Invest. Ophthalmol. Vis. Sci. 2014;55(13):5055.
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To evaluate visual and anatomic outcomes following treatment with intravitreal aflibercept injection (IAI) and laser in subgroups of DME patients with and without prior anti-VEGF therapy for DME.
VISTA-DME and VIVID-DME were two similarly designed phase 3 studies that randomized 872 DME patients 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. An exploratory analysis examined the improvements in BCVA and central retinal thickness (CRT) at week 52 in patients with and without prior anti-VEGF therapy.
Overall, 27.0% of patients had prior anti-VEGF therapy for DME at baseline. The adjusted treatment difference (IAI minus laser [97.5% confidence interval]) in mean BCVA change from baseline to week 52 in the 2q4 and 2q8 groups was 10.8 (8.8, 12.8) and 9.8 (7.9, 11.8) letters in the total patients population, 11.8 (7.6, 15.9) and 11.7 (8.1, 15.4) letters in a subgroup of patients with prior anti-VEGF therapy, and 10.5 (8.2, 12.8) and 9.2 (6.9, 11.4) letters in a subgroup of patients without prior anti-VEGF therapy, respectively. The corresponding adjusted treatment difference for mean change in CRT was -132.7 (-155.4, -109.9) and -127.1 (-150.8, -103.4) μm in the total patient population, -108.9 (-154.1, -63.8) and -116.5 (-161.4, -71.6) μm in a subgroup of patients with prior anti-VEGF therapy, and -142.3 (-168.9, 115.6) and -131.8 (-160.1, -103.6) μm in a subgroup of patients without prior anti-VEGF therapy, respectively. The overall incidence of ocular and non-ocular adverse events and serious adverse events, including the Anti-Platelet Trialists’ Collaboration-defined arterial thromboembolic events, was similar across treatment groups in the total patient population.
Visual and anatomic improvements over laser with both IAI regimens in subgroups of patients with and without prior anti-VEGF therapy were similar.
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