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Anecortave Acetate in the Treatment of Neovascular Age-related Macular Degeneration
Schmidt-Erfurth U.,
Medizinische Universität zu Lübeck, Klinik für Augenheilkunde (Lübeck)
Background: The pharmacological inhibition of angiogenesis is a novel, non-invasive therapeutic concept in neovascular retinal disease such as choroidal neovascularization (CNV) in age-related macular degeneration (AMD). Anecortave acetate, a chemically modified steroid derivative, has proven its antiangiogenic efficacy in multiple preclinical studies. The compound has now been used in two phase II clinical trials in patients with CNV due to AMD.
Patients and methods: Two randomized, placebo-controlled, double-masked studies were designed to evaluate the efficacy and safety of Anecortave Acetate alone as well as in combination with photodynamic therapy (PDT). A total of 128 patients were enrolled into the Anecortave Acetate monotherapy trial and 136 patients participated in the anecortave/PDT trial. In the ongoing monotherapy trial, Anecortave Acetate is applied via local and extraocular juxtascleral administration underneath Tenons capsule at the posterior pole, with 3 dosages (30mg, 15mg and 3mg) tested against placebo. Treatments are repeated at 6-month intervals if the patient would benefit in the investigators opinion. In the completed 6-month study combining Anecortave Acetate with PDT, a single injection of Anecortave Acetate (30mg or 15mg) or placebo was given 1 week following PDT.
Results: Analysis of 6 month data from the monotherapy study revealed a very positive trend with more patients showing vision stabilization in the 15mg Anecortave Acetate group compared to placebo (88% versus 70%). When only the predominantly classic lesions were compared across treatment groups, 92% of patients treated with 15 mg Anecortave Acetate maintained visual acuity compared to 65% of placebo-treated patients, a difference which is statistically significant (p = 0.021). 18% of eyes which had received 15mg Anecortave Acetate demonstrated an increase in visual acuity of at least 2 lines whereas no patient who received placebo showed an improvement, a difference which is also statistically significant (p = 0.025). The combination of Anecortave Acetate (30mg or 15mg) with PDT achieved stabilization in 78% of patients compared to 67% of patients treated with PDT alone, which represents a trend favoring Anecortave Acetate treatment. An increase in intraocular pressure or cataract formation was not observed.
Conclusions: Local antiangiogenesis is a therapeutic option which has demonstrated efficacy and safety at 6 months in two clinical trials, one of which is ongoing. The functional benefit of anecortave acetate is currently being evaluated in prospective trials phase III.