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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00451152
First Posted: March 23, 2007
Last Update Posted: November 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  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
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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure (IOP) [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Percent Treatment Failures [ Time Frame: 3 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00451152     History of Changes
Other Study ID Numbers: C-06-19
First Submitted: March 21, 2007
First Posted: March 23, 2007
Last Update Posted: November 28, 2012
Last Verified: May 2012

Keywords provided by Alcon Research:
glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Anecortave
Hydrocortisone
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents