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A collaborative retrospective trial on the efficacy and safety of intravitreal dexamethasone implant (Ozurdex) in patients with diabetic macular edema (ARTES study)

Session Details

Session Title: Vascular Diseases and Diabetic Retinopathy III

Session Date/Time: Friday 12/09/2014 | 16:30-18:00

Paper Time: 16:30

Venue: Boulevard D

First Author: : A.Loewenstein ISRAEL

Co Author(s): :    E. Moisseiev              

Abstract Details

Purpose:

Diabetic macular edema (DME) is the primary cause of visual loss in patients with diabetes. Corticosteroids have been shown to be useful in the treatment of DME. Ozurdex is a biodegradable slow-release dexamethasone implant that is injected intravitreally, and has been proven effective in the treatment of macular edema secondary to retinal vein occlusion and uveitis. In recent years, it has also been used off-label to treat DME. The purpose of this study is to review the safety and efficacy of repeated treatment with Ozurdex in clinical practice management of patients with DME.

Setting:

Multicenter, worldwide retrospective study.

Methods:

Retrospective chart review of all patients who were treated with two or more Ozurdex injections for the treatment of DME, and have been followed for at least 6 months following the last injcection. Only patients over 18 years with visual acuity of 20/200 or better and central retinal thickness of 300 microns or more at the time of first Ozurdex injection will be included. Patients with other retinopathies or significant ocular morbidity will be excluded. Patients who had received other treatment for their DME prior to Ozurdex will be included. Both eyes of a single patients may be included if they meet the inclusion criteria. The main outcome measure wil be the percentage of patients who have improved by 15 letters with Ozurdex treatment.

Results:

We plan to include at least 400 patients from over 20 centers worldwide. Data will be analyzed to evaluate the efficacy and safety of treatment with repeated Ozurdex injections for DME. Its usefulness will be compared between treatment-naïve and previously treated patients, and wil also be correlated with the duration of DME prior to treatment.

Conclusions:

This work presents the ARTES study design.

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