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NCT00451152 Clinical Trial

Safety and Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00451152
Other study ID # C-06-19
Secondary ID
Status Completed
Phase Phase 2
First received March 21, 2007
Last updated November 27, 2012
Start date March 2007
Est. completion date July 2009

Study information
Verified date May 2012
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of anecortave acetate for treatment of elevated IOP in patients with open-angle glaucoma.

Recruitment information / eligibility
Status Completed
Enrollment 89
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of open-angle glaucoma;

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Pseudoexfoliation;

- Pigment dispersion component;

- Other protocol-defined exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Anecortave Acetate Sterile Suspension, 30 mg/mL
Administered by anterior juxtascleral depot (AJD) in study eye, either 0.25 mL or 0.5 mL. One injection, 24 months.
Other:
• Anecortave Acetate Vehicle
Administered by anterior juxtascleral depot (AJD) in study eye, 0.5 mL. One injection, 24 months.

Locations
Country Name City State
United States Texas San Antonio Texas

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 (IOP) 3 months No
Secondary Percent Treatment Failures 3 months No
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