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Clinical Trials |

Randomized Controlled Study of an Intravitreous Dexamethasone Drug Delivery System in Patients With Persistent Macular Edema

Baruch D. Kuppermann, MD, PhD; Mark S. Blumenkranz, MD; Julia A. Haller, MD; George A. Williams, MD; David V. Weinberg, MD; Connie Chou, PhD; Scott M. Whitcup, MD ; Dexamethasone DDS Phase II Study Group
Arch Ophthalmol. 2007;125(3):309-317. doi:10.1001/archopht.125.3.309.
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Objective  To evaluate a dexamethasone intravitreous drug delivery system (DDS) in patients with persistent (≥90 days despite treatment) macular edema.

Methods  This 6-month study randomized 315 patients with persistent macular edema with best-corrected visual acuity (BCVA) of 20/40 to 20/200 in the study eye to observation or a single treatment with dexamethasone DDS, 350 or 700 μg.

Main Outcome Measures  Proportion of patients achieving a BCVA improvement of 10 or more letters or 15 or more letters, safety measures, change in fluorescein angiographic leakage, and central retinal thickness.

Results  At day 90 (primary end point), an improvement in BCVA of 10 letters or more was achieved by a greater proportion of patients treated with dexamethasone DDS, 700 μg (35%) or 350 μg (24%), than observed patients (13%; P<.001 vs 700-μg group; P = .04 vs 350-μg group); an improvement in BCVA of 15 letters or more was achieved in 18% of patients treated with dexamethasone DDS, 700 μg, vs 6% of observed patients (P = .006). Results were similar in patients with diabetic retinopathy, vein occlusion, or uveitis or Irvine-Gass syndrome. During 3 months of observation, 11% of treated patients and 2% of observed patients had intraocular pressure increases of 10 mm Hg or higher.

Conclusion  In persistent macular edema, a single dexamethasone DDS treatment produced statistically significant BCVA improvements 90 days after treatment and was well tolerated for 180 days.

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

Trial Registration  clinicaltrials.gov Identifier: "http://clinicaltrials.gov/show/NCT00035906"

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Figure 1.

Dexamethasone drug delivery system (DDS). A, Dexamethasone DDS implants. The larger implant is the 700-μg dose, and the smaller implant is the 350-μg dose. B. Approximate location of the dexamethasone DDS (indicated with the arrow; shown larger than actual size for illustrative purposes) after insertion into the eye.

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Figure 2.

Patient flow through the study.

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Figure 3.

Percentage of patients achieving improvement in best-corrected visual acuity of 10 letters or more or 15 letters or more. P values are for the dexamethasone drug delivery system (DDS) 700-μg group vs the observation group (P≤.025 was considered statistically significant).

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