A Dose-Volume Study of a Treatment for Elevated IOP Due to Open-Angle Glaucoma or Ocular Hypertension

This study has been terminated.
(Project cancellation)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00788541
First received: November 7, 2008
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

The purpose of this study was to assess the effects of total volume and total dose on the safety and intraocular pressure-lowering efficacy of Anecortave Acetate Suspension (3 mg and 48 mg) in 0.5 mL and 0.8 mL volumes 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
Ocular Hypertension
Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL
Drug: Anecortave Acetate Sterile Suspension, 3.75 mg/mL
Drug: Anecortave Acetate Sterile Suspension, 96 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 Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Dose-Volume 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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent of patients who remain rescue-medication free [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Enrollment: 197
Study Start Date: December 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3 mg Anecortave Acetate, low volume high dose
Anecortave Acetate Sterile Suspension, 6 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months.
Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL
Administered as an injection into an anterior juxtascleral depot
Experimental: 3 mg Anecortave Acetate, high volume low dose
Anecortave Acetate Sterile Suspension, 3.75 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months.
Drug: Anecortave Acetate Sterile Suspension, 3.75 mg/mL
Administered as an injection into an anterior juxtascleral depot
Experimental: 48 mg Anecortave Acetate, low volume high dose
Anecortave Acetate Sterile Suspension, 96 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months.
Drug: Anecortave Acetate Sterile Suspension, 96 mg/mL
Administered as an injection into an anterior juxtascleral depot
Experimental: 48 mg Anecortave Acetate, high volume low dose
Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months.
Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML
Administered as an injection into an anterior juxtascleral depot
Placebo Comparator: Anecortave Acetate Vehicle, low volume
Anecortave Acetate Vehicle, one injection of 0.5 mL in the study eye monthly for 6 months.
Other: Anecortave Acetate Vehicle
Administered as an injection into an anterior juxtascleral depot
Placebo Comparator: Anecortave Acetate Vehicle, high volume
Anecortave Acetate Vehicle, one injection of 0.8 mL in the study eye monthly for 6 months.
Other: Anecortave Acetate Vehicle
Administered as an injection into an anterior juxtascleral depot

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Open-Angle Glaucoma or Ocular Hypertension for at least 6 months;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Prior angle surgery in the study eye, severe visual field loss in either eye;
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788541

Locations
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00788541     History of Changes
Other Study ID Numbers: C-08-049
Study First Received: November 7, 2008
Last Updated: November 28, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Open-Angle Glaucoma
Intraocular Pressure
Anecortave Acetate

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

ClinicalTrials.gov processed this record on April 23, 2014