Back to resultsA Dose-Volume Study of a Treatment for Elevated IOP Due to Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Open-Angle Glaucoma, Ocular Hypertension
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anecortave Acetate Sterile Suspension, 6 mg/mL
Anecortave Acetate Sterile Suspension, 3.75 mg/mL
Anecortave Acetate Sterile Suspension, 96 mg/mL
Anecortave Acetate Sterile Suspension, 60 mg/ML
Anecortave Acetate Vehicle
Sponsored by
About this trial
This is an interventional prevention trial for Open-Angle Glaucoma focused on measuring Open-Angle Glaucoma, Intraocular Pressure, Anecortave Acetate
Eligibility 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.
Sites / Locations
- Contact Alcon Call Center For Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
3 mg Anecortave Acetate, low volume high dose
3 mg Anecortave Acetate, high volume low dose
48 mg Anecortave Acetate, low volume high dose
48 mg Anecortave Acetate, high volume low dose
Anecortave Acetate Vehicle, low volume
Anecortave Acetate Vehicle, high volume
Arm Description
Anecortave Acetate Sterile Suspension, 6 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months.
Anecortave Acetate Sterile Suspension, 3.75 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months.
Anecortave Acetate Sterile Suspension, 96 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months.
Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months.
Anecortave Acetate Vehicle, one injection of 0.5 mL in the study eye monthly for 6 months.
Anecortave Acetate Vehicle, one injection of 0.8 mL in the study eye monthly for 6 months.
Outcomes
Primary Outcome Measures
Mean Intraocular Pressure
Secondary Outcome Measures
Percent of patients who remain rescue-medication free
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00788541
Brief Title
A Dose-Volume Study of a Treatment for Elevated IOP Due to Open-Angle Glaucoma or Ocular Hypertension
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 Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
Project cancellation
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension
Keywords
Open-Angle Glaucoma, Intraocular Pressure, Anecortave Acetate
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3 mg Anecortave Acetate, low volume high dose
Arm Type
Experimental
Arm Description
Anecortave Acetate Sterile Suspension, 6 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months.
Arm Title
3 mg Anecortave Acetate, high volume low dose
Arm Type
Experimental
Arm Description
Anecortave Acetate Sterile Suspension, 3.75 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months.
Arm Title
48 mg Anecortave Acetate, low volume high dose
Arm Type
Experimental
Arm Description
Anecortave Acetate Sterile Suspension, 96 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months.
Arm Title
48 mg Anecortave Acetate, high volume low dose
Arm Type
Experimental
Arm Description
Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months.
Arm Title
Anecortave Acetate Vehicle, low volume
Arm Type
Placebo Comparator
Arm Description
Anecortave Acetate Vehicle, one injection of 0.5 mL in the study eye monthly for 6 months.
Arm Title
Anecortave Acetate Vehicle, high volume
Arm Type
Placebo Comparator
Arm Description
Anecortave Acetate Vehicle, one injection of 0.8 mL in the study eye monthly for 6 months.
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate Sterile Suspension, 6 mg/mL
Intervention Description
Administered as an injection into an anterior juxtascleral depot
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate Sterile Suspension, 3.75 mg/mL
Intervention Description
Administered as an injection into an anterior juxtascleral depot
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate Sterile Suspension, 96 mg/mL
Intervention Description
Administered as an injection into an anterior juxtascleral depot
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate Sterile Suspension, 60 mg/ML
Intervention Description
Administered as an injection into an anterior juxtascleral depot
Intervention Type
Other
Intervention Name(s)
Anecortave Acetate Vehicle
Intervention Description
Administered as an injection into an anterior juxtascleral depot
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percent of patients who remain rescue-medication free
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Contact Alcon Call Center For Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Dose-Volume Study of a Treatment for Elevated IOP Due to Open-Angle Glaucoma or Ocular Hypertension
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