Posterior Juxtascleral Delivery of Anecortave Acetate for the Treatment of Choroidal Neovascularization Long-term Outcomes and Current Status
Schmidt-Erfurth U., Michels S., Michels R, Robertson S., Michaud J.-E., and the Anecortave Acetate Clinical Study Group
University Hospital Schleswig-Holstein, Campus Luebeck
Purpose: To evaluate the clinical efficacy of angiostatic anecortave acetate administered as a posterior juxtascleral depot in patients with subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD)
Method: 128 patients were treated at 18 sites world-wide in the ongoing prospective dose-response study over 24 months of follow-up. Patients were randomized to either anecortave acetate at dosages of 3, 15 or 30 mg or placebo treatment. Patients were re-treated at 6-month intervals, if the patient could benefit in the investigators opinion. Clinical safety has been monitored with periodic physical and detailed ophthalmic examinations. Clinical efficacy is being assessed by evaluations of logMAR visual acuity based on ETDRS criteria and angiographic lesion characteristics over time.
Results: An evaluation of the Month 12 data in late 2002 showed that anecortave acetate at a dose of 15mg was statistically superior to placebo. This advantage was found in respect to prevention of both moderate vision loss (79% vs. 53%, p = 0.0323) and severe vision loss (3% vs. 23%, p = 0.0224). There was also a trend favoring anecortave acetate (15mg) for inhibition of CNV growth. No clinically relevant drug-related or administration-r
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