Vision-related functioning outcomes of dexamethasone intravitreal implant in noninfectious intermediate or posterior uveitis.

Abstract

PURPOSE:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.).

• Authors: Susan Lightman, Rubens Belfort Jr, Rupali K Naik, Careen Lowder, C Stephen Foster, Anne M Rentz, Harry Cui, Scott M Whitcup, Jonathan W Kowalski, Dennis A Revicki
• Journal: Investigative ophthalmology & visual science (Invest Ophthalmol Vis Sci) Vol. 54 Issue 7 Pg. 4864-70 (Jul 18 2013) ISSN: 1552-5783 [Electronic] United States
• PMID: 23761087 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• Drug Implants
• Dexamethasone

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Analysis of Variance
• Anti-Inflammatory Agents (administration & dosage)
• Dexamethasone (administration & dosage)
• Drug Implants
• Female
• Humans
• Intravitreal Injections
• Male
• Middle Aged
• Surveys and Questionnaires
• Uveitis, Posterior (drug therapy, physiopathology)
• Visual Acuity (physiology)
• Young Adult