Back to resultsSafety and Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma
Primary Purpose
Open-angle Glaucoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anecortave Acetate Sterile Suspension, 30 mg/mL
Anecortave Acetate Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma focused on measuring glaucoma
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of open-angle glaucoma;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Pseudoexfoliation;
- Pigment dispersion component;
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Texas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Anecortave Acetate Depot
Anecortave Acetate Vehicle
Arm Description
Outcomes
Primary Outcome Measures
Mean Intraocular Pressure (IOP)
Secondary Outcome Measures
Percent Treatment Failures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00451152
Brief Title
Safety and Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma
Official Title
A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of anecortave acetate for treatment of elevated IOP in patients with open-angle glaucoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma
Keywords
glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anecortave Acetate Depot
Arm Type
Experimental
Arm Title
Anecortave Acetate Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate Sterile Suspension, 30 mg/mL
Intervention Description
Administered by anterior juxtascleral depot (AJD) in study eye, either 0.25 mL or 0.5 mL. One injection, 24 months.
Intervention Type
Other
Intervention Name(s)
Anecortave Acetate Vehicle
Intervention Description
Administered by anterior juxtascleral depot (AJD) in study eye, 0.5 mL. One injection, 24 months.
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure (IOP)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Percent Treatment Failures
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of open-angle glaucoma;
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Pseudoexfoliation;
Pigment dispersion component;
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Landry, Ph.D.
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78257
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma
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