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Anecortave Acetate in Patients With Open-angle Glaucoma

Registration Number
NCT00320203
Lead Sponsor
Alcon Research
Brief Summary

The purpose of this study is to evaluate the safety, efficacy, and duration of effect of a single administration of Anecortave Acetate Depot for treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
86
Inclusion Criteria
  • Patients 18 years of age or older with open-angle glaucoma.
  • Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
  • Patients with open-angle glaucoma with a pseudoexfoliation or pigment dispersion component.
  • Other protocol-defined exclusion criteria may apply.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Anecortave Acetate 15 mg DepotAnecortave Acetate Sterile Suspension, 30 mg/mLSingle injection, anterior juxtascleral depot (AJD)
Anecortave Acetate 30 mg DepotAnecortave Acetate Sterile Suspension, 60 mg/mLSingle injection, anterior juxtascleral depot (AJD)
Anecortave Acetate 3 mg DepotAnecortave Acetate Sterile Suspension, 6 mg/mLSingle injection, anterior juxtascleral depot (AJD)
Anecortave Acetate VehicleAnecortave Acetate VehicleSingle injection, anterior juxtascleral depot (AJD)
Primary Outcome Measures
NameTimeMethod
Mean change in intraocular pressure at 9 am from baselineWeeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12
Secondary Outcome Measures
NameTimeMethod
Time to treatment failureAt time point
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