Baseline Characteristics of a Phase 3 Clinical Study of Anecortave Acetate 15 mg in Patients With Exudative Age–Related Macular Degeneration (AMD)

Abstract

Abstract: : Purpose: To report the baseline characteristics of Study C–01–99, a phase 3 study of Anecortave Acetate 15 mg administered as a periocular posterior juxtascleral depot (PJD) or PDT with VISUDYNE^® in patients with predominantly classic lesions due to exudative AMD. Methods: Patients enrolled into this study had a diagnosis of exudative AMD in their study eye with subfoveal choroidal neovascularization that was eligible for treatment with verteporfin PDT. Demographic characteristics, best corrected logMAR visual acuity (VA) and lesion characteristics by fluorescein and ICG angiography and fundus photography were assessed at baseline. Patients received treatment with Anecortave Acetate 15 mg at baseline and 6 month intervals or PDT at baseline and every 3 months if leakage was present. No prior laser or PDT treatments were permitted. Results: Of the 530 patients enrolled, 522 were eligible for the per protocol analysis. Most patients were Caucasian (97.7%) There were no significant differences between treatment groups for mean age, gender or iris color. The mean baseline logMAR VA was 0.74 (48 ETDRS letters read correctly) in the Anecortave Acetate group and 0.71 in the PDT group. Mean lesion size was 3.7 mm² for both treatment groups and the median time from diagnosis was 37 days. There was a high incidence of small, recently diagnosed classic CNV lesions which are indicative of rapidly progressing aggressive lesions. The incidence of retinal angiomatous proliferation (RAP), subfoveal hemorrhage and fluid, and subfoveal hot spots was unusually high in this study compared to previous studies of AMD patients. Conclusions: The baseline characteristics of Study C–01–99 indicate that the lesion size was smaller and younger than previously observed in the studies of patients with predominantly classic lesions. The presence of a high incidence of characteristics such as RAP, extensive subretinal hemorrhage/fluid and subfoveal hotspots suggests that this study included unusually aggressive lesions.

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