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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eye Diseases
Ocular Hypertension
Anecortave
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014