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Susan Lightman, Rubens Belfort, Rupali K. Naik, Careen Lowder, C. Stephen Foster, Anne M. Rentz, Harry Cui, Scott M. Whitcup, Jonathan W. Kowalski, Dennis A. Revicki; Vision-Related Functioning Outcomes of Dexamethasone Intravitreal Implant in Noninfectious Intermediate or Posterior Uveitis. Invest. Ophthalmol. Vis. Sci. 2013;54(7):4864-4870. doi: 10.1167/iovs.12-10981.
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To evaluate the effect of a single treatment with dexamethasone intravitreal implant (DEX implant) on patient-reported visual functioning in patients with noninfectious intermediate or posterior uveitis.
Patient eyes with noninfectious intermediate or posterior uveitis were randomized to a single treatment with DEX implant 0.70 mg (n = 77), DEX implant 0.35 mg (n = 76), or a sham procedure (n = 76) and followed for 26 weeks. Vision-related functioning was measured using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) assessed at baseline and at weeks 8, 16, and 26 or early exit. Analysis of covariance and mixed model analysis of covariance were used to compare vision-related functioning between the DEX implant 0.70 and 0.35 mg groups and the sham group.
By 8 weeks, the DEX implant 0.70 mg group demonstrated significant improvements in NEI VFQ-25 subscales near vision (P = 0.031), distance vision (P = 0.023), peripheral vision (P = 0.045), vision-specific social functioning (P = 0.019), and the NEI VFQ-25 composite score (P = 0.007) compared with sham. After 26 weeks, the DEX implant 0.70 mg group reported significant improvements in NEI VFQ-25 subscales distance vision (P = 0.003), vision-specific role difficulties (P = 0.038), vision-specific dependency (P = 0.017), vision-specific social functioning (P = 0.009), vision-specific mental health (P = 0.036), and the composite score (P = 0.001) compared with sham.
In patients with noninfectious intermediate or posterior uveitis receiving a single treatment of DEX implant 0.70 mg, significant and clinically meaningful improvements in patient-reported visual functioning were observed as early as week 8 and were maintained over 26 weeks. (ClinicalTrials.gov number, NCT00333814.)
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