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Dexamethasone posterior-segment drug delivery system in the treatment of macular edema resulting from uveitis or Irvine-Gass syndrome. Am J Ophthalmol 2009 Jun;147(6):1048-54, 1054.e1-2

Date

03/10/2009

Pubmed ID

19268890

DOI

10.1016/j.ajo.2008.12.033

Scopus ID

2-s2.0-67349125916 (requires institutional sign-in at Scopus site)   173 Citations

Abstract

PURPOSE: To evaluate the effects of a dexamethasone intravitreous drug delivery system (dexamethasone DDS) in patients with persistent macular edema (ME) resulting from uveitis or Irvine-Gass syndrome.

DESIGN: Randomized, prospective, single-masked, controlled trial.

METHODS: Three hundred and fifteen patients with persistent (>or= 90 days) ME were randomized in a multicenter study to surgical placement of 350 or 700 microg dexamethasone DDS or observation. This study evaluated the subset of patients with uveitis or Irvine-Gass syndrome (n = 41). The primary outcome measure was the proportion of patients achieving a 10-letter or more improvement in best-corrected visual acuity (BCVA) at day 90. Change in fluorescein angiographic leakage and safety also were evaluated.

RESULTS: At day 90, a 10-letter or more BCVA improvement was seen in 41.7% (5/12) of patients in the 350-microg group, in 53.8% (7/13) of patients in the 700-microg group, and in 14.3% (2/14) of patients in the observation group (P = .029 vs the 700-microg group). Improvement in visual acuity persisted to day 180. A 15-letter or more improvement was achieved in 53.8% (7/13) of 700-microg patients vs 7.1% (1/14) of observed patients (P = .008). There were significantly greater reductions in fluorescein leakage in treated patients than in observed patients. Dexamethasone DDS was well tolerated. Throughout the study, an increase in intraocular pressure of 10 mm Hg or more was seen in 5 of 13 patients in the 700-microg group, in 1 of 12 patients in the 350-microg group, and in no patients in the observation group. There were no reports of endophthalmitis.

CONCLUSIONS: In patients with persistent ME resulting from uveitis or Irvine-Gass syndrome, 700-microg dexamethasone DDS was well tolerated and produced statistically significant improvements in visual acuity and fluorescein leakage.

Author List

Williams GA, Haller JA, Kuppermann BD, Blumenkranz MS, Weinberg DV, Chou C, Whitcup SM, Dexamethasone DDS Phase II Study Group

Author

David V. Weinberg MD Professor in the Ophthalmology and Visual Sciences department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Aged
Cataract Extraction
Dexamethasone
Drug Delivery Systems
Female
Fluorescein Angiography
Follow-Up Studies
Glucocorticoids
Humans
Macular Edema
Male
Prospective Studies
Single-Blind Method
Treatment Outcome
Uveitis
Visual Acuity
Vitreous Body