Anecortave Acetate Risk-Reduction Trial (AART)
Phase 3
Terminated
- Conditions
- Dry AMD
- Interventions
- Other: Anecortave Acetate Vehicle
- Registration Number
- NCT00307398
- Lead Sponsor
- Alcon Research
- Brief Summary
A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg or sham administration every 6 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2596
Inclusion Criteria
- Dry AMD study eye, Wet AMD non-study eye.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Age
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AL-3789 Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg One injection to the study eye by the posterior juxtascleral depot procedure at 6-month intervals for 42 months. Anecortave Acetate Vehicle Anecortave Acetate Vehicle One sham injection to the study eye at 6-month intervals for 42 months. Syringe containing AA vehicle was not inserted into the eye.
- Primary Outcome Measures
Name Time Method Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at Month 48 Month 48 ST-CNV is defined as CNV or a portion of CNV within 2500 microns of the foveal center, as evidenced by digital angiography at the clinical site.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Study Centers in the United States and Globally
🇺🇸Fort Worth, Texas, United States