Peter K. Kaiser, MD (Cleveland, OH)*

PURPOSE:

An update of the baseline characteristics of the Anecortave Acetate Risk Reduction Study (AART, C-02-60) evaluating the efficacy and safety of posterior juxtascleral administrations (PJD) of anecortave acetate versus sham in patients at risk for developing sightthreatening choroidal neovascularization (CNV), and of the combination study with an anti-VEGF antiangiogenic agent (Bridge Trial).

METHODS:

Patients enrolled in AART had exudative AMD in non-study eye and multiple intermediate/large soft and/or confluent drusen, and hyperpigmentation, with no evidence of exudative AMD or geographic atrophy in the study eye. Patients enrolled in Bridge Trial are treated with an anti-VEGF agent combined with anecortave acetate as a maintenance therapy to assess the possibility of reducing the number of injections while maintaining visual results.

RESULTS:

In the AART trial, two prospective Phase III clinical trials with identical protocols enrolled and treated 2,596 p tients. Baseline data are currently available for 2,200 patients and include demographics and baseline fundus and angiographic data which will be presented. The primary outcome for the AART trial is the percentage of patients who develop sightthreatening CNV in the study eye in this 48 month study. The rationale, study design and enrollment status of the Bridge Trial will be presented.

CONCLUSION:

The 6 month dosing interval, multi-factorial mechanism of action and safety profile of the angiostatic agent, Anecortave acetate, suggest that it is ideally suited for combination therapy in wet AMD and for reducing the risk of conversion from dry to wet AMD.
* Financial interest disclosed