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C.D. Regillo, D. D'Amico, W. Mieler, C. Beasley, Anecortave Acetate Clinical Study Group; Safety Outcomes of Clinical Studies for Anecortave Acetate in Patients With Exudative Age–Related Macular Degeneration (AMD) . Invest. Ophthalmol. Vis. Sci. 2005;46(13):1373.
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Purpose: To access the safety of the angiostatic cortisene Anecortave Acetate administered as a periocular posterior juxtascleral depot (PJD) as primary therapy and with photodynamic therapy (PDT) in patients with exudative age–related macular degeneration. Methods: The clinical safety of the development of Anecortave Acetate has been assessed with periodic physical examinations and detailed ophthalmic examinations including assessments of intraocular pressure and cataractous lens changes and adverse event reporting. Results: The clinical development of Anecortave Acetate for the treatment of neovascular AMD included 883 patients in 8 clinical studies. There were 459 patients with at least 6 months of exposure and 269 with at least 12 months exposure to Anecortave Acetate. Analysis of ocular (visual acuity, ocular signs, lens opacities, lens abnormalities, eyelid/pupil responsiveness, IOP, posterior segment abnormalities and ocular motility) and non–ocular ( general physical examination, EKG, cardiovascular and laboratory) parameters and adverse events revealed no safety concerns for the overall safety of patients receiving Anecortave Acetate as primary therapy as well as when administered with PDT. Conclusions: Anecortave Acetate is safe and well–tolerated when administered as a posterior juxtascleral depot at 6–month intervals. No clinically significant treatment–related ocular or systemic changes have been identified by the Independent Safety Committee during their periodic evaluations of the safety data from these studies.
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