Anecortave Acetate Risk-Reduction Trial (AART)
Phase 3
Terminated
- Conditions
- AMD
- Interventions
- Other: Anecortave Acetate Vehicle
- Registration Number
- NCT00333216
- Lead Sponsor
- Alcon Research
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 15 mg Anecortave Acetate Anecortave Acetate Sterile Suspension, 30 mg/mL Anecortave Acetate Sterile Suspension, 30 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months 30 mg Anecortave Acetate Anecortave Acetate Sterile Suspension, 60 mg/ML Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months Anecortave Acetate Vehicle Anecortave Acetate Vehicle Anecortave Acetate Vehicle, one sham injection in the study eye every 6 months for 48 months
- Primary Outcome Measures
Name Time Method Proportion of patients with sight-threatening CNV in study eye Month 48
- Secondary Outcome Measures
Name Time Method Time to development of sight-threatening CNV Up to 48 months Proportion of patients with stable vision Up to 48 months
Trial Locations
- Locations (1)
Contact Alcon Call Center for Trial Locations
🇺🇸Fort Worth, Texas, United States