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J.S. Slakter, Anecortave Acetate Clinical Study Group; Demographics and Baseline Characteristics of Patients in the Anecortave Acetate Risk Reduction Trial (AART) . Invest. Ophthalmol. Vis. Sci. 2006;47(13):2109.
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To provide baseline characteristics and demographics for patients enrolled in the Anecortave Acetate Risk Reduction Study (AART, C–02–60).
Patients with exudative AMD in the non–study eye and multiple intermediate/large soft and/or confluent drusen, hyperpigmentation, and no evidence of exudative AMD or geographic atrophy in the eye to be treated were enrolled in two randomized, prospective Phase III clinical trials with identical protocols. Approximately 2500 patients were randomized equally to posterior juxtascleral administrations of anecortave acetate or to a sham procedure with treatment every 6 months. The duration of this study is four years. The percentage of patients with sight–threatening CNV in the study eye at Month 48 is the primary outcome measure. A secondary outcome is the time to development of sight–threatening CNV and the percentage of patients with stable vision (< 3 line loss from baseline in logMAR visual acuity as compared to baseline) at 24, 36 and 48 months.
Approximately 2500 patients have been enrolled at 78 US and 35 international sites. Baseline characteristics and demographics including sex, age, and baseline visual acuity will be presented for these patients with dry AMD who are at risk of converting to exudative AMD. Specific attention will be paid to vitamin use, smoking and hypertension history, fundus characteristics of the study eye, and fellow eye lesion characteristics and treatment history.
The safety profile, mechanism of action, and dosing interval suggest that anecortave acetate is a good candidate for reducing the risk of CNV and vision loss in eyes with "at risk" dry AMD. The AART study is designed to determine if such an effect can be achieved.
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