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H.L. Hudson, G.E. Fish, D. Dahlin, C. Carvalho, R.D. Faulkner, M.A. Curtis, S.M. Robertson; Clinical Outcomes of Two Open–Label Pharmacokinetic Studies With Anecortave Acetate in Patients With Exudative Age–Related Macular Degeneration (AMD) . Invest. Ophthalmol. Vis. Sci. 2005;46(13):1375.
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PURPOSE: To report the clinical outcomes of two open–label pharmacokinetic studies designed to characterize the profile of 30 mg (Study 1) and 15 mg (Study 2) Anecortave Acetate administered as a periocular posterior juxtascleral depot (PJD) in patients with minimally classic, occult and/or predominantly classic lesions due to exudative AMD. METHODS: Analyses of best corrected logMAR visual acuity (VA) and lesion characteristics were conducted for both studies. Patients could receive concomitant treatment with PDT if they were eligible. Plasma samples were analyzed for active anecortave desacetate and other metabolites by tandem HPLC/mass spectrometry. Additional data analyses examined the effect of reflux of medication from the administration site. Results: Twenty–two of the 34 patients enrolled in Study 1 and 10 of the 20 patients in Study 2 received concomitant PDT. The percentage of patients who maintained vision (< 3 lines loss or 15 ETDRS letters – % responders) for Study 1 was 72% and 81% for Study 2 after 12 months of treatment including 2 PJD administrations. All lesion types performed equally well. There was no systemic accumulation of anecortave desacetate or other metabolites after repeated (PJD) administration of Anecortave Acetate. Lower plasma concentrations of anecortave desacetate were seen in patients with reflux of study medication. These findings were extended to analyze reflux in the pivotal efficacy trials. Conclusions: Clinical efficacy results of these studies indicate that patients with predominantly classic, mixed or occult lesions are effectively treated after 12 months of therapy with Anecortave Acetate with PDT added to therapy in eligible patients. Assessment of reflux was beneficial in the analysis of efficacy data from Phase III trials.
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