Purchase this article with an account.
DJ D'Amico, J Duker, C Regillo, C Schneebaum, C Beasley; Anecortave Acetate Administered Sub-Tenon’s Retrobulbar with and without Visudyne PDT in Patients with Subfoveal Age-Related Macular Degeneration (AMD) – Clinical Safety Profile . Invest. Ophthalmol. Vis. Sci. 2002;43(13):569.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
Purpose:Since 1998, the Independent Safety Committee has provided an independent medical expert review of safety information related to the two ongoing clinical trials evaluating the angiostatic agent anecortave acetate when administered as a sub-Tenon’s retrobulbar bolus to patients with subfoveal AMD. This Committee is composed of three clinical retina specialists in addition to an internist and the Alcon Medical Monitor responsible for the safety oversight of these studies. Meetings of the Committee have included both telephone conferences and in-person meetings to periodically review the accumulating body of safety information. Methods:Safety information is derived from general physical examinations and dilated ophthalmic examinations of the patients in both trials including indocyanine green and/or fluorescein angiograms. Results:Enrollment has been completed for both of these studies. In study C-98-03, which evaluates anecortave acetate monotherapy, 128 patients have been enrolled and treated. In study C-00-07, which evaluates the effect of anecortave acetate following PDT treatment with Visudyne(TM), 136 patients have been enrolled and treated. During the most recent Safety Committee meeting, 400 safety events from C-98-03 and 180 safety events from C-00-07 were reviewed and discussed. Based on their review of safety changes, there has been no request by the Committee to make any study design changes or to interrupt enrollment in either study. Conclusion:The Independent Safety Committee has reviewed the accumulating safety reports of all changes in patients enrolled in two clinical trials evaluating the effect of anecortave acetate on patients with subfoveal AMD. There have been no clinically significant safety issues identified by the Independent Safety Committee to date.
This PDF is available to Subscribers Only