Randomized controlled trial of an intravitreous dexamethasone drug delivery system in patients with diabetic macular edema.
OBJECTIVE
To evaluate the safety and efficacy of a dexamethasone intravitreous drug delivery system (DDS) in eyes with diabetic macular edema (DME).


METHODS
Patients with persistent macular edema (> or = 90 days' duration) were randomized to treatment with 700 microg or 350 microg of dexamethasone DDS or observation. One eye from each patient was designated as the study eye. The analysis is of the eyes in this study with DME (n = 171).


METHODS
The primary outcome measure was the proportion of eyes that achieved an improvement in best-corrected visual acuity (BCVA) of 10 letters or more from baseline at day 90. Other outcome measures included fluorescein leakage, central retinal thickness, and safety parameters.


RESULTS
At day 90, a BCVA improvement of 10 letters or more was seen in more eyes in the 700-microg group (33.3%) and 350-microg group (21.1%) than the observation group (12.3%; P = .007 vs 700-microg group). At day 180, a BCVA improvement of 10 letters or more was seen in 30% of eyes in the 700-microg group, 19% in the 350-microg group, and 23% in the observation group (P > or = .4 for treated vs observed eyes). There were also significantly greater improvements in central retinal thickness and fluorescein leakage in treated eyes than observed eyes (P = .03; day 90). Dexamethasone DDS was well tolerated.


CONCLUSIONS
In eyes with persistent DME, treatment with 700 microg of intravitreal dexamethasone DDS is well tolerated and produces significant improvements in BCVA, central retinal thickness, and fluorescein leakage compared with observation (statistically significant at day 90).


CONCLUSIONS
Dexamethasone DDS, 700 microg, may have potential as a treatment for persistent DME.


BACKGROUND
clinicaltrials.gov Identifier: NCT00035906.
Haller
Julia A
JA
Wills Eye Institute, 840 Walnut St, Ste 1510, Philadelphia, PA 19107, USA. jhaller@willseye.org
Kuppermann
Baruch D
BD
Blumenkranz
Mark S
MS
Williams
George A
GA
Weinberg
David V
DV
Chou
Connie
C
Whitcup
Scott M
SM
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002199:Capillary Permeability; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D003930:Diabetic Retinopathy / Q000188:drug therapy* / Q000503:physiopathology; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007267:Injections; D008269:Macular Edema / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D014822:Vitreous Body; D055815:Young Adult
D003907:Dexamethasone; D005938:Glucocorticoids; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human