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Clinical Trials |

Randomized Controlled Trial of an Intravitreous Dexamethasone Drug Delivery System in Patients With Diabetic Macular Edema

Julia A. Haller, MD; Baruch D. Kuppermann, MD, PhD; Mark S. Blumenkranz, MD; George A. Williams, MD; David V. Weinberg, MD; Connie Chou, PhD; Scott M. Whitcup, MD
Arch Ophthalmol. 2010;128(3):289-296. doi:10.1001/archophthalmol.2010.21.
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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 (≥90 days' duration) were randomized to treatment with 700 μg or 350 μg 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).

Main Outcome Measures  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-μg group (33.3%) and 350-μg group (21.1%) than the observation group (12.3%; P = .007 vs 700-μg group). At day 180, a BCVA improvement of 10 letters or more was seen in 30% of eyes in the 700-μg group, 19% in the 350-μg group, and 23% in the observation group (P ≥ .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 μg 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).

Application to Clinical Practice  Dexamethasone DDS, 700 μg, may have potential as a treatment for persistent DME.

Trial Registration  clinicaltrials.gov Identifier: NCT00035906

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Figure.

Percentage of patients who achieved 10 letters or more or 15 letters or more of improvement in best-corrected visual acuity. P values represent the comparison between the 700-μg group and the observation group. DDS indicates drug delivery system.

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