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Anecortave Acetate in Patients With Open-angle Glaucoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00320203
First Posted: May 3, 2006
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 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
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 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 ]

Secondary Outcome Measures:
  • Time to treatment failure [ Time Frame: At time point ]

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

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:

  • 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
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): NCT00320203


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00320203     History of Changes
Other Study ID Numbers: C-04-62
First Submitted: May 1, 2006
First Posted: May 3, 2006
Last Update Posted: November 28, 2012
Last Verified: February 2008

Keywords provided by Alcon Research:
open-angle
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