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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00451152
First received: March 21, 2007
Last updated: November 27, 2012
Last verified: May 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure (IOP) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Treatment Failures [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: March 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451152

Locations
United States, Texas
Texas
San Antonio, Texas, United States, 78257
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Theresa Landry, Ph.D. Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00451152     History of Changes
Other Study ID Numbers: C-06-19
Study First Received: March 21, 2007
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014