NCT00315640
Completed
Phase 2
A Study of the Safety and Efficacy of Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation
ConditionsEye Diseases
Overview
- Phase
- Phase 2
- Intervention
- Anecortave Acetate Sterile Suspension, 6 mg/mL
- Conditions
- Eye Diseases
- Sponsor
- Alcon Research
- Enrollment
- 70
- Locations
- 11
- Primary Endpoint
- Mean change in IOP at Week 4 from Baseline
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Anecortave Acetate 3 mg Depot
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Intervention: Anecortave Acetate Sterile Suspension, 6 mg/mL
Anecortave Acetate 15 mg Depot
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Intervention: Anecortave Acetate Suspension Depot, 30 mg/mL
Anecortave Acetate 30 mg Depot
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Intervention: Anecortave Acetate Sterile Suspension, 60 mg/mL
Anecortave Acetate Vehicle
Intervention: Anecortave Acetate Vehicle
Outcomes
Primary Outcomes
Mean change in IOP at Week 4 from Baseline
Time Frame: Week 4
Study Sites (11)
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