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Anecortave Acetate in Patients With Open-angle Glaucoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00320203
First received: May 1, 2006
Last updated: November 27, 2012
Last verified: February 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Open-angle Glaucoma
 Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL
Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL
Drug: Anecortave Acetate Sterile Suspension, 60 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:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean change in intraocular pressure at 9 am from baseline [ Time Frame: Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to treatment failure [ Time Frame: At time point ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: March 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anecortave Acetate 3 mg Depot
Single injection, anterior juxtascleral depot (AJD)
 Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL
Single injection, anterior juxtascleral depot (AJD)
Experimental: Anecortave Acetate 15 mg Depot
Single injection, anterior juxtascleral depot (AJD)
 Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL
Single injection, anterior juxtascleral depot (AJD)
Experimental: Anecortave Acetate 30 mg Depot
Single injection, anterior juxtascleral depot (AJD)
 Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL
Single injection, anterior juxtascleral depot (AJD)
Anecortave Acetate Vehicle
Single injection, anterior juxtascleral depot (AJD)
 Other: Anecortave Acetate Vehicle
Single injection, anterior juxtascleral depot (AJD)

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320203

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Theresa Landry Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00320203     History of Changes
Other Study ID Numbers: C-04-62
Study First Received: May 1, 2006
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
open-angle
glaucoma

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

ClinicalTrials.gov processed this record on May 16, 2013