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J. Kowalski, A. Rentz, D. Revicki, R. Belfort, Jr., J. A. Haller, C.-C. Liu, S. M. Whitcup; Effect of Dexamethasone Intravitreal Implant on Patient-Reported Visual Functioning for the Treatment of Macular Edema Following Retinal Vein Occlusion. Invest. Ophthalmol. Vis. Sci. 2010;51(13):4726.
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© ARVO (1962-2015); The Authors (2016-present)
To assess the effect of dexamethasone intravitreal implant (OZURDEX) treatment on visual functioning as measured by the National Eye Institute Visual Function Questionnaire-25 (VFQ-25) in patients with macular edema (ME) following branch or central retinal vein occlusion (RVO).
Patients were randomized to DEX Implant 0.7 mg or 0.35 mg or sham injection (needleless applicator) in two, 6-month multicenter, masked, randomized, sham-controlled trials with a 6-month open-label extension period. VFQ-25 scores were obtained at Days 0, 30, 60, 90, and 180. Comparisons among treatment groups were performed with repeated-measures ANCOVA.
1,151 of 1,267 enrolled patients (64% BRVO, 36% CRVO) with a VFQ-25 score at Day 0 and at least 1 follow-up visit were included in the analysis. Mean age was 64.8 years, with 53% male and 78% white. For the initial 180-day treatment period, treatment by visit interactions were observed in the ANCOVA models for distance vision (P = .028), general vision (P = .014), role difficulties (P = .086), and VFQ-25 composite (P = .025) scores. Statistically significant differences were observed between 0.7-mg group and sham group on near vision (P = .041), distance vision (P = .005), general vision (P < .001), role difficulties (P = .043), mental health (P = .038), and VFQ-25 composite scores (P = .007). No statistically significant differences were observed between the 0.35-mg and sham groups.
A single treatment with DEX Implant 0.7 mg resulted in improvement compared to sham on 5 VFQ-25 subscales and composite score over the initial 180-day treatment period in patients with ME following RVO.
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