Reflux of Study Medication Affects the Clinical Outcomes of Anecortave Acetate for Depot Suspension in the Treatment of Patients With Exudative Age–Related Macular Degeneration (AMD)

Abstract

Abstract: : Purpose: To compare clinical efficacy outcomes of two Anecortave Acetate studies with and without reflux of study medication. Methods: Study 1 (C–98–03): A randomized, placebo–controlled, masked 24 month study of Anecortave Acetate (3 mg, 15 mg and 30 mg) vs. Placebo enrolled 128 patients with predominantly and minimally classic lesions. Patients were retreated with a periocular posterior juxtascleral depot (PJD) administered at six month intervals if the patient could benefit. Study 2 (C–01–99): A randomized, masked, 12 month study with 12 months follow–up compared Anecortave Acetate 15 mg plus sham photodynamic therapy (PDT) vs. PDT plus sham PJD administration in 530 patients with predominantly classic lesions. Patients were retreated with Anecortave Acetate or sham PJD every 6 months. Analyses for visual acuity outcomes with and without reflux were done. Results: The efficacy of Anecortave Acetate was improved when reflux was absent and a full dose of drug was properly delivered. This improvement was observed in both C–98–03 (90% without reflux vs. 74% with reflux) and C–01–99 (50% without reflux vs. 39% with reflux). The responder rate was 50% for Anecortave Acetate 15 mg without reflux and 49% for PDT in C–01–99. In C–98–03 the responder rates were 90% for Anecortave Acetate 15 mg without reflux and 53% for Placebo. Conclusions: The efficacy of Anecortave Acetate is improved when reflux of study medication is managed.

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