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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00691717
First received: June 3, 2008
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure at 8 am [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of Patients Who Remained Rescue Medication-Free at Month 3 (8 am) [ Time Frame: Month 3, 8 am ] [ Designated as safety issue: No ]

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

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 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691717

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00691717     History of Changes
Other Study ID Numbers: C-07-36
Study First Received: June 3, 2008
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 22, 2013