April 2010
Volume 51, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2010
12-Month Evaluation of Dexamethasone Intravitreal Implant in Patients With Macular Edema Due to Branch Retinal Vein Occlusion
Author Affiliations & Notes
  • J. A. Haller
    Ophthalmology, Wills Eye Institute, Philadelphia, Pennsylvania
  • F. Bandello
    Surgical Science (Ophthalmology), University of Udine, Udine, Italy
  • J. Jiao
    Allergan, Inc, Irvine, California
  • X.-Y. Li
    Clinical Ophthalmology,
    Allergan, Inc, Irvine, California
  • S. M. Whitcup
    R & D,
    Allergan, Inc, Irvine, California
  • Footnotes
    Commercial Relationships  J.A. Haller, Allergan, Genentech, C; Macusight, Optimedica, I; F. Bandello, Allergan, Novartis, C; Allergan, Novartis, R; J. Jiao, Allergan, E; X.-Y. Li, Allergan, E; S.M. Whitcup, Allergan, E.
  • Footnotes
    Support  Allergan, Inc.
Investigative Ophthalmology & Visual Science April 2010, Vol.51, 2439. doi:
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      J. A. Haller, F. Bandello, J. Jiao, X.-Y. Li, S. M. Whitcup; 12-Month Evaluation of Dexamethasone Intravitreal Implant in Patients With Macular Edema Due to Branch Retinal Vein Occlusion. Invest. Ophthalmol. Vis. Sci. 2010;51(13):2439.

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

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Abstract

Purpose: : To evaluate the effects of OZURDEX (dexamethasone intravitreal implant) in patients with macular edema (ME) due to branch retinal vein occlusion (BRVO).

Methods: : In 2 identical masked studies, eyes with ME due to BRVO were randomized to receive DEX Implant 0.7 mg, DEX Implant 0.35 mg, or sham. Patients could receive open-label treatment with DEX Implant 0.7 mg at Day 180 if best-corrected visual acuity (BCVA) was 250µm. Eyes entering the open-label phase (treated or untreated) were followed for an additional 6 months. Key outcomes were BCVA, central retinal thickness, and safety.

Results: : At baseline, 291 eyes received DEX Implant 700µg and 279 received sham; of these 241/291 (83%) in the DEX Implant group and 235/279 (84%) in the Sham group had BRVO for >90 days. At Day 180, 227 from the 0.7 mg group and 210 from the sham group received open-label treatment with DEX Implant 0.7 mg. At least 15 letters of BCVA was gained in 30% of eyes 60 Days after the first DEX Implant 0.7 mg (peak effect) and 34% gained >/=15 letters 60 Days after the second implant (Day 240); 29% of eyes from the sham group that received their first DEX Implant 0.7 mg at Day 180 gained >/=15-letters by Day 240. Among eyes that only received a single, baseline DEX Implant 0.7 mg (n=61), 30% gained >/=15-letters at Day 60, 46% at Day 180, and 43% at Day 360. Eyes with BRVO <=90 days responded better than eyes with chronic ME. Increases in IOP were similar and generally transient following each DEX Implant.

Conclusions: : In patients with ME due to BRVO, DEX Implant 0.7 mg produced substantial improvements in BCVA and was well-tolerated. The response to a second DEX Implant 0.7 mg after 6 months was similar.

Clinical Trial: : www.clinicaltrials.gov NCT00168298, NCT00168324

Keywords: corticosteroids • retina 
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