Open-Label Posterior Juxtascleral Injections of Anecortave Acetate 15mg Dose for Long Term Use in Patients With AMD
Phase 3
Terminated
- Conditions
- Macular Degeneration
- Interventions
- Registration Number
- NCT00065728
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to investigate the long-term efficacy and safety of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 111
Inclusion Criteria
- Patients with subfoveal exudative age-related macular degeneration (AMD) who were previously enrolled in long-term studies with anecortave acetate.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Anecortave Acetate, 15 mg Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months
- Primary Outcome Measures
Name Time Method Percent of patients who maintained stable vision Month 24 Stable vision is defined as \< 15-letter loss of best-corrected visual acuity scores)
Mean change in best-corrected visual acuity at Month 24 from baseline Baseline, Month 24
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Belgium,France,Germany,Hungary,Italy,Netherlands,Poland,Spain,Sweden,UK
🇺🇸Central Contact Ft. Worth, Texas, United States