Dexamethasone posterior-segment drug delivery system in the treatment of macular edema resulting from uveitis or Irvine-Gass syndrome.
OBJECTIVE
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.


METHODS
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.
Williams
George A
GA
Beaumont Eye Institute, Royal Oak, Michigan, USA. gwilliams@beaumont.edu
Haller
Julia A
JA
Kuppermann
Baruch D
BD
Blumenkranz
Mark S
MS
Weinberg
David V
DV
Chou
Connie
C
Whitcup
Scott M
SM
D000368:Aged; D002387:Cataract Extraction / Q000009:adverse effects*; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D016503:Drug Delivery Systems; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008269:Macular Edema / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D008297:Male; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome; D014605:Uveitis / Q000150:complications*; D014792:Visual Acuity / Q000502:physiology; D014822:Vitreous Body
D005938:Glucocorticoids; D003907:Dexamethasone