Anecortave Acetate in Subfoveal Choroidal Neovascularization (CNV) Due to Wet Age-Related Macular Degeneration (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: NCT00051129
• Other study ID #: C-02-27
• Status: Completed
• Phase: Phase 3
• First received: January 3, 2003
• Last updated: November 27, 2012
• Start date: January 2007
• Est. completion date: May 2008

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 anecortave acetate compared to placebo for maintenance of visual acuity after 24 months of treatment in patients with subfovial choroidal neovascularization (CNV) due to exudative age-related macular degeneration (AMD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of exudative AMD and a primary or recurrent subfoveal CNV lesion in the study eye.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Under 50 years.

• Other protocol-defined exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Anecortave Acetate 15 mg sterile suspension
0.5 ml of 30 mg/ml administered as a posterior juxtascleral injection

Other:
• Anecortave Acetate Vehicle
Administered as a posterior juxtascleral injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in logMAR visual acuity score at 12 months		Month 12	No