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

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ClinicalTrials.gov Identifier: NCT00788541
Recruitment Status : Terminated (Project cancellation)
First Posted : November 11, 2008
Last Update Posted : November 30, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2008
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Mean Intraocular Pressure [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Percent of patients who remain rescue-medication free [ Time Frame: 6 Months ]


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:

  • 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.

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): NCT00788541


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00788541     History of Changes
Other Study ID Numbers: C-08-049
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: November 30, 2012
Last Verified: November 2012

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

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