Anecortave Acetate Risk Reduction Trial (AART)
Phase 3
Terminated
- Conditions
- AMD
- Interventions
- Other: Anecortave Acetate Vehicle
- Registration Number
- NCT00332657
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of dry age-related macular degeneration (AMD) in patients who are at-risk for progressing to wet AMD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Dry AMD in study eye, Wet AMD 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 Anecortave Acetate, 30 mg Anecortave Acetate Sterile Suspension, 60 mg/mL One 0.5 mL injection of 60 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months. Anecortave Acetate, 15 mg Anecortave Acetate Sterile Suspension, 30 mg/mL One 0.5 mL injection of 30 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months. Anecortave Acetate Vehicle Anecortave Acetate Vehicle One sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.
- Primary Outcome Measures
Name Time Method Proportion of patients with sight-threatening choroidal neovascularization (CNV) in study eye Month 48
- Secondary Outcome Measures
Name Time Method Time to development of sight-threatening CNV Timepoint
Trial Locations
- Locations (1)
India
🇮🇳Bangalore, India