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NCT00320203 Clinical Trial

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 NCT00320203
Other study ID # C-04-62
Secondary ID
Status Completed
Phase Phase 2
First received May 1, 2006
Last updated November 27, 2012
Start date March 2006
Est. completion date January 2008

Study information
Verified date February 2008
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 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.

Recruitment information / eligibility
Status Completed
Enrollment 86
Est. completion date January 2008
Est. primary completion date January 2008
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.

- 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

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, 6 mg/mL
Single injection, anterior juxtascleral depot (AJD)
• Anecortave Acetate Sterile Suspension, 30 mg/mL
Single injection, anterior juxtascleral depot (AJD)
• Anecortave Acetate Sterile Suspension, 60 mg/mL
Single injection, anterior juxtascleral depot (AJD)
Other:
• Anecortave Acetate Vehicle
Single injection, anterior juxtascleral depot (AJD)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change in intraocular pressure at 9 am from baseline Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12 No
Secondary Time to treatment failure At time point No
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