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Abstract
Abstract
Anecortave Acetate for Subfoveal CNV Long-Term Clinical Safety and Feasibility of a Standardized Route of Administration
Augustin A. J., Dahlin D. and the Independent Safety Committee, and the Anecortave Acetate Clinical Study Group
Augenklinik, Klinikum Karlsruhe
Purpose: To evaluate clinical safety and feasibility of administering anecortave acetate as a posterior juxtascleral drug depot with a specially designed cannula.
Method: To date, this unique route of administration has been used in five clinical trials evaluating anecortave acetate for treatment of subfoveal CNV secondary to AMD. Clinical safety results from two of these five studies after 6 to 36 months of treatment with single or multiple administrations have been reviewed by the Independent Safety Committee. Systemic clinical safety of anecortave acetate was assessed by periodic general physical examinations and evaluations of blood chemistry/CBC/urin analysis. Ophthalmic safety was assessed by periodic detailed ophthalmic examinations.
Results: As of March 2003, 454 patients have received a total of 697 posterior juxtascleral administrations of anecortave acetate or placebo at 6-month intervals. Multiple re-treatments have been performed into the same quadrant of the orbit through small incisions. Adverse events to date typically have been mild, transient, observed in all treatment groups, and generally assessed as unrelated to study medication. Adverse events possibly related to the injection technique itself include ptosis, ocular pain and subconjunctival hemorrhage.
Conclusions:
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