Anecortave Acetate Versus Placebo in AMD Patients Following PDT

AMD Clinical Trial

Official title:

Anecortave Acetate Versus Placebo in AMD Patients Following PDT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346866
• Other study ID #: C-00-07
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2006
• Last updated: August 4, 2008
• Start date: May 2000
• Est. completion date: December 2001

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 was to evaluate the efficacy of anecortave acetate for depot suspension (30 mg and 15 mg) plus PDT versus PDT alone with respect to maintenance of visual acuity in patients with wet AMD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 2001
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• AMD disease

Exclusion Criteria:

• Age

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AMD

Intervention

Drug:
• anecortave acetate

Locations

Country	Name	City	State
United States	Facility	Beachwood	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from the baseline in logMAR visual acuity score at Month 6
Secondary	% patients who maintained vision, number of months of angiographic evidence of needing PDT re-treatment, and mean lesion sizes for the total choroidal neovascularization (CNV) and the classic component to the total CNV.