Abstract
Purpose: :
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).
Methods: :
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.
Results: :
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.
Conclusions: :
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.
Keywords: corticosteroids • macula/fovea