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
  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:


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
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: 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 July 29, 2014