December 2002
Volume 43, Issue 13
ARVO Annual Meeting Abstract  |   December 2002
Sub-Tenon’s Administration of the Angiostatic Agent Anecortave Acetate in AMD Patients with Subfoveal Choroidal Neovascularization (CNV) - the Clinical Outcome
Author Affiliations & Notes
  • JS Slakter
    Vitreous Ret Mac Consult of NY New York NY
  • LJ Singerman
    Retina Associates of Cleveland Cleveland OH
  • LA Yannuzzi
    Vitreous Ret Mac Consltants of New York New York NY
  • SR Russell
    Ophthalmology University of Iowa Iowa City IA
  • HL Hudson
    Retina Center PC Tucson AZ
  • J Jerdan
    Alcon Research Ltd Fort Worth TX
  • P Zilliox
    Alcon Research Ltd Fort Worth TX
  • S RobertsonAnecortave Acetate Study Group
    Alcon Research Ltd Fort Worth TX
  • Footnotes
    Commercial Relationships    J.S. Slakter, Alcon Research Ltd. C; Novartis Ophthalmics, Inc. C; L.J. Singerman, None; L.A. Yannuzzi, None; S.R. Russell, None; H.L. Hudson, None; J. Jerdan, Alcon Research, Ltd. E; P. Zilliox, Alcon Research, Ltd. E; S. Robertson, Alcon Research, Ltd. E.
Investigative Ophthalmology & Visual Science December 2002, Vol.43, 2909. doi:
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      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.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract: : 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.

Keywords: 308 age-related macular degeneration • 346 choroid: neovascularization • 357 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials 

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