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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00451152
• Collaborator: (none)
• Enrollment: 89
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma	Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL; Other: Anecortave Acetate Vehicle	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anecortave Acetate Depot	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.
Placebo Comparator: Anecortave Acetate Vehicle	Other: Anecortave Acetate Vehicle; Administered by anterior juxtascleral depot (AJD) in study eye, 0.5 mL. One injection, 24 months.

Outcome Measures

Primary Outcome Measures

1. Mean Intraocular Pressure (IOP) [3 months]

Secondary Outcome Measures

1. Percent Treatment Failures [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas	San Antonio	Texas	United States	78257

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Theresa Landry, Ph.D., Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00451152
• Other Study ID Numbers: C-06-19
• First Posted: Mar 23, 2007
• Last Update Posted: Nov 28, 2012
• Last Verified: May 1, 2012

• Keywords provided by Alcon Research: glaucoma
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Hydrocortisone; Anecortave

Study Results

No Results Posted as of Nov 28, 2012