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NCT00691717 Clinical Trial

Anecortave Acetate Safety in Patients With Open-Angle Glaucoma or Ocular Hypertension

Open-angle Glaucoma Clinical Trial

Official title:
A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00691717
Other study ID # C-07-36
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received June 3, 2008
Last updated November 27, 2012
Start date June 2008
Est. completion date September 2009

Study information
Verified date November 2012
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the safety and intraocular-lowering efficacy of anecortave acetate depot when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility
Status Completed
Enrollment 201
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients 18 years of age or older with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation) or ocular hypertension.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Patients with any form of glaucoma other than open-angle.

- Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Anecortave Acetate Sterile Suspension, 30 mg/mL
Single administration by anterior juxtascleral depot
• Anecortave Acetate Sterile Suspension, 60 mg/mL
Single administration by anterior juxtascleral depot
• Anecortave Acetate Sterile Suspension, 75 mg/mL
Single administration by anterior juxtascleral depot
Other:
• Anecortave Acetate Vehicle
Single administration by anterior juxtascleral depot

Locations
Country Name City State
United States Charleston Charleston South Carolina

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Intraocular Pressure at 8 am Up to 6 months No
Secondary Percent of Patients Who Remained Rescue Medication-Free at Month 3 (8 am) Month 3, 8 am No
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