Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation
Phase 2
Completed
- Conditions
- Eye Diseases
- Interventions
- Registration Number
- NCT00315640
- Lead Sponsor
- Alcon Research
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of anecortave acetate depot when administered for the treatment of elevated IOP following treatment with steroids.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- Either gender
- 18 years of age or older
- IOP elevation caused by steroid usage
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria
- Under 18 years of age
- Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anecortave Acetate 3 mg Depot Anecortave Acetate Sterile Suspension, 6 mg/mL One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye Anecortave Acetate 15 mg Depot Anecortave Acetate Suspension Depot, 30 mg/mL One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye Anecortave Acetate 30 mg Depot Anecortave Acetate Sterile Suspension, 60 mg/mL One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye Anecortave Acetate Vehicle Anecortave Acetate Vehicle -
- Primary Outcome Measures
Name Time Method Mean change in IOP at Week 4 from Baseline Week 4
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Bayamon
🇵🇷Bayamon, Puerto Rico
Budapest
🇭🇺Budapest, Hungary
Amsterdam
🇳🇱Amsterdam, Netherlands
Jacksonville
🇺🇸Jacksonville, Florida, United States
Miami
🇺🇸Miami, Florida, United States
San Paulo
🇧🇷San Paulo, Brazil
Newcastle upon Tyne
🇬🇧Newcastle upon Tyne, United Kingdom
Detroit
🇺🇸Detroit, Michigan, United States
Houston
🇺🇸Houston, Texas, United States
Padova
🇮🇹Padova, Italy
Barcelona
🇪🇸Barcelona, Spain