Anecortave Acetate Risk-Reduction Trial (AART)

AMD Clinical Trial

Official title:

Efficacy and Safety of Posterior Juxtascleral Administrations of Anecortave Acetate for Depot Suspension (15 mg or 30 mg) Versus Sham Administration in Singaporean Patients at Risk for Progressing to Exudative Age-Related Macular Degeneration (AMD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00333216
• Other study ID #: C-04-30
• Status: Terminated
• Phase: Phase 3
• First received: May 31, 2006
• Last updated: November 27, 2012
• Start date: May 2005
• Est. completion date: December 2008

Study information

• Verified date: December 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSingapore: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of non-exudative (dry) age-related macular degeneration in patients who are at risk for progressing to exudative (wet) age-related macular degeneration.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Dry AMD in study eye, Wet AMD in non-study eye;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Under 50;

• 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: Prevention

Related Conditions & MeSH terms

• AMD

Intervention

Drug:
• Anecortave Acetate Sterile Suspension, 30 mg/mL
Posterior juxtascleral administration of suspension
• Anecortave Acetate Sterile Suspension, 60 mg/ML
Posterior juxtascleral administration of suspension

Other:
• Anecortave Acetate Vehicle
Sham posterior juxtascleral administration of suspension

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with sight-threatening CNV in study eye		Month 48	No
Secondary	Time to development of sight-threatening CNV		Up to 48 months	No
Secondary	Proportion of patients with stable vision		Up to 48 months	No