April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
Efficacy of Dexamethasone Intravitreal Implant for Best Corrected Visual Acuity in Patients With Retinal Vein Occlusion After 7 Days
Baruch D. Kuppermann; Julia A. Haller; Francesco Bandello; Rubens Belfort, Jr.; Anat Loewenstein; Mark Gillies,; Jeffrey S. Heier; Jenny Jiao; Xiao-Yan Li; Scott M. Whitcup
Author Affiliations & Notes
  • Baruch D. Kuppermann
    Gavin Herbert Eye Inst Dept Ophthal, University of California Irvine, Irvine, California
  • Julia A. Haller
    Ophthalmology, Wills Eye Institute, Philadelphia, Pennsylvania
  • Francesco Bandello
    Ophthalmology, Univ Vita-Salute Scientific Institute, San Raffaele, Milan, Italy
  • Rubens Belfort, Jr.
    Vision Instute, Dept. of Ophthalmology, Federal University of São Paulo, Sao Paulo, Brazil
  • Anat Loewenstein
    Ophthalmology, Tel-Aviv Medical Center, Tel Aviv, Israel
  • Mark Gillies,
    Dept of Clinical Ophthalmology, Save Sight Institute, Univ of Sydney, Sydney, Australia
  • Jeffrey S. Heier
    Ophthalmic Consultants of Boston, Boston, Massachusetts
  • Jenny Jiao
    Biostats,
    Allergan, Inc, Irvine, California
  • Xiao-Yan Li
    Clinical Ophthalmology,
    Allergan, Inc, Irvine, California
  • Scott M. Whitcup
    R & D,
    Allergan, Inc, Irvine, California
  • Footnotes
    Commercial Relationships  Baruch D. Kuppermann, Allergan, CoMentis, Genentech, Glaukos, Neovista, Novagali, SurModics, TareGen, Ophthotech, OPKO Health, Vitreoretinal Technologies (C); Julia A. Haller, Allergan, Genentech (C); Francesco Bandello, Allergan, Novartis (C); Rubens Belfort, Jr., Allergan, Alcon (C); Anat Loewenstein, Allergan, NotalVision (C); Mark Gillies,, Allergan, NotalVision, Pfizer (C); Jeffrey S. Heier, Allergan (F), Allergan, Alimera, Genentech, Regenenon; (C); Jenny Jiao, Allergan (E); Xiao-Yan Li, Allergan (E); Scott M. Whitcup, Allergan (E)
  • Footnotes
    Support  Allergan, Inc.
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 3966. doi:
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      Baruch D. Kuppermann, Julia A. Haller, Francesco Bandello, Rubens Belfort, Jr., Anat Loewenstein, Mark Gillies,, Jeffrey S. Heier, Jenny Jiao, Xiao-Yan Li, Scott M. Whitcup; Efficacy of Dexamethasone Intravitreal Implant for Best Corrected Visual Acuity in Patients With Retinal Vein Occlusion After 7 Days. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3966.

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Abstract

Purpose: : To evaluate efficacy 7 days after treatment of dexamethasone intravitreal (DEX) implant (Ozurdex®) 0.7 mg compared with sham procedure in patients with vision loss due to macular edema (ME) following retinal vein occlusion (RVO).

Methods: : Patients ≥ 18 years with fovea-involved ME due to BRVO or CRVO, BCVA between 34 (20/200) and 68 letters (20/50), and retinal thickness of ≥ 300 µm enrolled into 2 identical 6-month, randomized, prospective, multicenter, masked, sham-controlled, parallel-group clinical trials. Patients received either DEX implant 0.7 mg or sham procedure.

Results: : 427 patients (68% BRVO; 32% CRVO) received DEX implant and 426 (66% BRVO; 34% CRVO) received sham procedure. Baseline mean BCVA was 54.3 letters (20/80) and 54.8 letters (20/80) in the DEX implant and sham arms, respectively. At day 7, mean improvement in BCVA was 5.3 letters and 1.6 letters in the DEX implant and sham arms, respectively (P ≤ .001). In the DEX implant and sham arms, mean improvement in BCVA was 5.1 letters and 2.3 letters in BRVO patients (P ≤ .001) and 5.8 letters and 0.08 letters in the DEX implant and sham arms in CRVO patients (P ≤ .001), respectively. The proportion of eyes achieving improvement in BCVA of ≥ 10 letters from baseline at day 7 in the DEX implant/sham arms were 27% and 11%, respectively (P ≤ .001). The proportion of eyes achieving improvement in BCVA of ≥ 15 letters was 10% and 5% in the DEX implant and sham arms, respectively (P = .025) in BRVO patients and 11% and 2% (P = .002) in CRVO patients.

Conclusions: : Significant improvements in BCVA were noted as early as 7 days after implantation of DEX implant in patients with RVO.

Clinical Trial: : http://www.clinicaltrials.gov 00168298 & 00168324

Keywords: vascular occlusion/vascular occlusive disease • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • corticosteroids 
© 2011, The Association for Research in Vision and Ophthalmology, Inc., all rights reserved. Permission to republish any abstract or part of an abstract in any form must be obtained in writing from the ARVO Office prior to publication.
Copyright © 2024 Association for Research in Vision and Ophthalmology.
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