April 2010
Volume 51, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2010
Efficacy of Dexamethasone Intravitreal Implant for the Treatment of Uveitis Based on Patient-Reported Vision Function Outcome Measures
Author Affiliations & Notes
  • R. K. Naik
    Global Health Outcomes,
    Allergan, Inc., Irvine, California
  • H. Gelhorn
    United BioSource Corporation, Bethesda, Maryland
  • J. Kowalski
    Glbl Hlth Outcomes Strat Res,
    Allergan, Inc., Irvine, California
  • H. Cui
    Allergan, Irvine, California
  • D. Revicki
    United BioSource Corporation, Bethesda, Maryland
  • C. Y. Lowder
    Cole Eye Inst-Ophthalmology, Cole Eye Institute, Cleveland, Ohio
  • R. Belfort, Jr.
    Ophthalmology, Federal University of Sao Paulo, Sao Paulo, Brazil
  • C. Foster
    Ophthalmology, Ocular Immunology and Uveitis Foundation, Cambridge, Massachusetts
  • S. Lightman
    Clinical Ophthal, Moorfields Eye Hospital, London, United Kingdom
  • S. M. Whitcup
    R & D, Allergan, Inc, Irvine, California
  • Footnotes
    Commercial Relationships  R.K. Naik, Allergan, E; H. Gelhorn, United BioSource, E; Allergan, C; J. Kowalski, Allergan, E; H. Cui, Allergan, E; D. Revicki, United BioSource, E; Allergan, C; C.Y. Lowder, Allergan, F; R. Belfort, Jr., Allergan, I; Allergan, Alcon, C; C. Foster, Alcon, Allergan, Bausch & Lomb, Eyegate, Genentech, Inspire, Ista, LUX, Merrimack, NIH, Novartis, Sirion, F; Abbott, Alcon, Allergan, Bausch & Lomb, Eyegate, Genentech, Inotech, Inspire, Ista, LUX, Merrimack, Novartis, Sirion, Therakine, C; Alcon, Allergan, Bausch & Lomb, Inspire, Ista, LUX, Sirion, R; S. Lightman, Allergan, C; S.M. Whitcup, Allergan, E.
  • Footnotes
    Support  Allergan, Inc.
Investigative Ophthalmology & Visual Science April 2010, Vol.51, 5875. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : 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.

Methods: : 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.

Results: : 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.

Conclusions: : 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.

Clinical Trial: : www.clinicaltrials.gov NCT00333814

Keywords: clinical (human) or epidemiologic studies: outcomes/complications 
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