April 2010
Volume 51, Issue 13
ARVO Annual Meeting Abstract  |   April 2010
Effect of Dexamethasone Intravitreal Implant on Patient-Reported Visual Functioning for the Treatment of Macular Edema Following Retinal Vein Occlusion
Author Affiliations & Notes
  • J. Kowalski
    Glbl Hlth Outcomes Strat Res,
    Allergan, Inc, Irvine, California
  • A. Rentz
    ClinResearch-a United BioSource Corporation Partner, Cologne, Germany
  • D. Revicki
    United BioSource Corporation, Bethesda, Maryland
  • R. Belfort, Jr.
    Ophthalmology, Vision Institute Federal University of Sao Paulo, Sao Paulo, Brazil
  • J. A. Haller
    Ophthalmology, Wills Eye Institute, Philadelphia, Pennsylvania
  • C.-C. Liu
    Allergan, Inc, Irvine, California
  • S. M. Whitcup
    R & D,
    Allergan, Inc, Irvine, California
  • Footnotes
    Commercial Relationships  J. Kowalski, Allergan, E; A. Rentz, United BioSource, C; D. Revicki, United BioSource, C; R. Belfort, Jr., Allergan, I; Allergan, Alcon, C; J.A. Haller, Macusight, Optimedica, I; Allergan, Genentech, C; C.-C. Liu, Allergan, E; S.M. Whitcup, Allergan, E.
  • Footnotes
    Support  Allergan, Inc.
Investigative Ophthalmology & Visual Science April 2010, Vol.51, 4726. doi:
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      J. Kowalski, A. Rentz, D. Revicki, R. Belfort, Jr., J. A. Haller, C.-C. Liu, S. M. Whitcup; Effect of Dexamethasone Intravitreal Implant on Patient-Reported Visual Functioning for the Treatment of Macular Edema Following Retinal Vein Occlusion. Invest. Ophthalmol. Vis. Sci. 2010;51(13):4726.

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      © ARVO (1962-2015); The Authors (2016-present)

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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 

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