An Evaluation of Safety and Efficacy of Anecortave Acetate Versus Placebo in Patients With Subfoveal CNV Due to Exudative AMD

Macular Degeneration Clinical Trial

Official title:

An Evaluation of Safety and Efficacy of Anecortave Acetate Versus Placebo in Patients With Subfoveal Choroidal Neovascularization Due to Exudative Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00058994
• Other study ID #: C-02-29
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2003
• Last updated: November 28, 2012
• Start date: March 2003
• Est. completion date: November 2006

Study information

• Verified date: August 2008
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate that anecortave acetate is superior to placebo in maintenance of visual acuity at the 12- and 24-month visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Patients at least 50 years of age, of any race, and either sex with a clinical diagnosis of exudative AMD and a primary or recurrent subfoveal CNV lesion in the study eye.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Maculopathy, Age-Related

Intervention

Drug:
• anecortave acetate

Locations

Country	Name	City	State
United States	South America	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States,