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Anecortave Acetate: A New Angiostatic Agent in Clinical Studies for Treatment of Exudative Age-related Macular Degeneration (AMD)
Müller-Velten R., Michels S., Beckendorf A., Schmidt-Erfurth U.,
Medizinische Universität zu Lübeck, Klinik für Augenheilkunde (Lübeck)
Introduction: The angiostatic agent anecortave acetate (AA) has been shown to inhibit blood vessel growth in multiple preclinical studies. Currently two clinical, masked, randomized trials for subfoveal choroidal neovascularisation (CNV) secondary to age-related maculardegeneration (AMD) in North America and the EU have been completed.
Methods: In both studies AA was administered as a sub-Tenon`s retrobulbar injection. The first Study (C-9803) was to designed to evaluate three AA dosages versus placebo with optional re-injection at 6-month intervals. The CNV had to be subfoveal and predominatly classic. In May 2001 enrollment was completed with 128 patients treated. The second study (C-0007) evaluated AA versus placebo following photodynamic treatment (PDT) with Visudyneâ. In this 6-months study with up to two PDTs patients were randomized to one of two dosages of AA or to placebo. Two groups were differentiated with classic CNV larger or smaller than 50% of the total CNV. Interpretation of fluorescein- and Indocyaningreen- angiography was done for the first time by a digital angiographic reading center (DARC), which communicated via internet with all sites.
Conclusions: Study data are currently analysed and will be presented for both studies. Sofar no safety issues of concern were reported or identified by the Independent Safety Committee for these studies. The use of angiostatic steroids is a promising treatment option in exudative AMD. A combination with PDT seems useful in optimising treatment results.