Anecortave Acetate Treatment of "Dry" AMD to Reduce Risk of Progression to "Wet" AMD – The Anecortave Acetate Risk Reduction Trial (AART)

Abstract

Abstract: : Purpose: A recently completed trial demonstrated that Anecortave Acetate 15 mg is superior to placebo treatment administered as a posterior juxtascleral depot every 6 months for stabilizing vision and suppressing choroidal neovascularization (CNV) growth. No clinically relevant safety issues related to either Anecortave Acetate or the administration procedure have been identified to date. In the AART study, Anecortave Acetate is being evaluated for arresting progression of dry AMD to exudative AMD in at–risk AMD patients using an important new efficacy measure, the incidence of "sight–threatening" CNV. Methods: Two Phase III studies with identical protocols involving approximately 100 sites will enroll about 2500 patients. Eligible patients will have exudative AMD in the non–study eye, and the eye to be treated will have multiple intermediate/large soft and/or confluent drusen, hyperpigmentation, and no evidence of exudative AMD or geographic atrophy. Patients will be randomized equally to posterior juxtascleral administrations of Anecortave Acetate or to a sham procedure every 6 months for 4 years. The primary efficacy measure for this study will be the development of "sight–threatening" CNV, defined as CNV within 2500 um of the foveal center. Results: Patient enrollment for this study is being initiated. Conclusions: In view of the demonstrated efficacy and safety profile of Anecortave Acetate administered as a posterior juxtascleral depot, this angiostatic cortisene is the first pharmacological therapeutic to be evaluated in this population of at–risk AMD patients.

Keywords: choroid: neovascularization • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • age–related macular degeneration