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
  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:


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
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: 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
Anecortave
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014