Purchase this article with an account.
JS Slakter, LJ Singerman, LA Yannuzzi, SR Russell, HL Hudson, J Jerdan, P Zilliox, S RobertsonAnecortave Acetate Study Group; Sub-Tenon’s Administration of the Angiostatic Agent Anecortave Acetate in AMD Patients with Subfoveal Choroidal Neovascularization (CNV) - the Clinical Outcome . Invest. Ophthalmol. Vis. Sci. 2002;43(13):2909.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
Purpose: To evaluate efficacy and safety of the angiostatic agent anecortave acetate for inhibition of subfoveal CNV lesion growth in AMD patients in two clinical studies. Changes in visual acuity and lesion characteristic are being evaluated as measures of efficacy. Methods: In both studies, a sterile suspension of anecortave acetate or placebo is administered as a sub-Tenon's retrobulbar injection via a specially designed cannula. The first study is a masked randomized evaluation of three anecortave acetate dosages versus placebo, with optional re-injection at 6-month intervals. The second masked randomized study evaluates anecortave acetate or placebo following initial Visudyne PDT. In this 6-month study, patients are randomized to a single injection of one of two dosages of anecortave acetate or to placebo. Patients with either predominantly classic or minimally classic subfoveal lesions are eligible for this study, which is evaluating the effect of anecortave acetate on visual acuity and post-PDT lesion changes. Results: Enrollment is complete in both studies with a total of 264 patients enrolled by 22 clinical sites in North America and the EU. In the first study, 128 patients have been enrolled and treated, with 78 of these patients receiving at least one additional injection. In the second study, 115 of the 136 enrolled and treated patients have completed the study and been exited. In both of these studies, digital fluorescein and indocyanine green angiograms are being evaluated by the Digital Angiography Reading Center (DARC), and lesion characteristics (lesion area, CNV area, classic CNV area) will be compared over time across treatment groups. Conclusion: Differences across treatment groups in both best-corrected logMAR visual acuity and angiographic lesion characteristics will be compared and discussed.
This PDF is available to Subscribers Only