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R. K. Naik, H. Gelhorn, J. Kowalski, H. Cui, D. Revicki, C. Y. Lowder, R. Belfort, Jr., C. Foster, S. Lightman, S. M. Whitcup; Efficacy of Dexamethasone Intravitreal Implant for the Treatment of Uveitis Based on Patient-Reported Vision Function Outcome Measures. Invest. Ophthalmol. Vis. Sci. 2010;51(13):5875.
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To evaluate the effect of a single treatment with dexamethasone intravitreal implant (OZURDEX) on patient-reported visual functioning in patients with noninfectious intermediate or posterior uveitis.
A 26-week multicenter, randomized, double-masked, sham-controlled, parallel group study with an 18-week masked extension was conducted to evaluate the safety and efficacy of DEX Implant 0.7 mg and 0.35 mg compared with a sham injection (needless applicator). Patient-reported visual functioning was assessed at baseline and at Weeks 8, 16, and 26 using the National Eye Institute Visual Function Questionnaire-25 (VFQ-25). Between-group comparisons for change from baseline in VFQ-25 scores at each visit were performed using one-way ANOVA.
229 patients (81% with intermediate and 19% with posterior uveitis) participated in the study. Mean age was 44.3 years; 60% were female; and the majority was white (61%). Statistically significant (P < .05) and clinically meaningful (5-point to 10-point change) improvement in mean change from baseline was observed for the 0.7-mg group compared to sham as early as Week 8 (7 subscales and composite score) and at Week 16 (5 subscales and composite score). At Week 26, these differences were maintained for 6 of the VFQ-25 subscales (distance vision, color vision, role limitations, dependency, social functioning, mental health) and for the overall composite score. For 9 of the VFQ-25 subscales and the composite score at Week 26, a trend of greater improvement from baseline was observed for the 0.7-mg group compared to the 0.35-mg group.
A single treatment with DEX Implant 0.7 mg compared to sham resulted in statistically significant and clinically meaningful improvement on 7 VFQ-25 subscales as soon as Week 8 and maintained for 6 subscales through 26 weeks.
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