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Anecortave Acetate Safety in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00691717
First Posted: June 5, 2008
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-lowering efficacy of anecortave acetate depot when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Condition Intervention Phase
Open-angle Glaucoma Oular Hypertension Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL Drug: Anecortave Acetate Sterile Suspension, 75 mg/mL Other: Anecortave Acetate Vehicle Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure at 8 am [ Time Frame: Up to 6 months ]

Secondary Outcome Measures:
  • Percent of Patients Who Remained Rescue Medication-Free at Month 3 (8 am) [ Time Frame: Month 3, 8 am ]

Enrollment: 201
Study Start Date: June 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 24 mg Anecortave Acetate
Anecortave Acetate Sterile Suspension, 30 mg/mL, single depot administration of 0.8 mL in the study eye
Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL
Single administration by anterior juxtascleral depot
Experimental: 48 mg Anecortave Acetate
Anecortave Acetate Sterile Suspension, 60 mg/mL, single depot administration of 0.8 mL in the study eye
Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL
Single administration by anterior juxtascleral depot
Experimental: 60 mg Anecortave Acetate
Anecortave Acetate Sterile Suspension, 75 mg/mL, single depot administration of 0.8 mL in the study eye
Drug: Anecortave Acetate Sterile Suspension, 75 mg/mL
Single administration by anterior juxtascleral depot
Placebo Comparator: Anecortave Acetate Vehicle
Single depot administration of 0.8 mL in the study eye
Other: Anecortave Acetate Vehicle
Single administration by anterior juxtascleral depot

  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 (with or without pigment dispersion or pseudoexfoliation) or ocular hypertension.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Patients with any form of glaucoma other than open-angle.
  • 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): NCT00691717


Locations
United States, South Carolina
Charleston
Charleston, South Carolina, United States, 29414
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00691717     History of Changes
Other Study ID Numbers: C-07-36
First Submitted: June 3, 2008
First Posted: June 5, 2008
Last Update Posted: November 28, 2012
Last Verified: November 2012

Keywords provided by Alcon Research:
Anecortave acetate
Open-angle glaucoma
IOP
OHT

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