Back to resultsAnecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation
Primary Purpose
Eye Diseases
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Anecortave Acetate Sterile Suspension, 6 mg/mL
Anecortave Acetate Suspension Depot, 30 mg/mL
Anecortave Acetate Sterile Suspension, 60 mg/mL
Anecortave Acetate Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Eye Diseases focused on measuring Elevated IOP due to intravitreal triamcinolone therapy
Eligibility Criteria
Inclusion Criteria: Either gender 18 years of age or older IOP elevation caused by steroid usage Other protocol-defined inclusion criteria may apply Exclusion Criteria: Under 18 years of age Other protocol-defined exclusion criteria may apply
Sites / Locations
- Jacksonville
- Miami
- Detroit
- Houston
- San Paulo
- Budapest
- Padova
- Amsterdam
- Bayamon
- Barcelona
- Newcastle upon Tyne
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Other
Arm Label
Anecortave Acetate 3 mg Depot
Anecortave Acetate 15 mg Depot
Anecortave Acetate 30 mg Depot
Anecortave Acetate Vehicle
Arm Description
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Outcomes
Primary Outcome Measures
Mean change in IOP at Week 4 from Baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00315640
Brief Title
Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation
Official Title
A Study of the Safety and Efficacy of Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
December 2005 (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
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of anecortave acetate depot when administered for the treatment of elevated IOP following treatment with steroids.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases
Keywords
Elevated IOP due to intravitreal triamcinolone therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anecortave Acetate 3 mg Depot
Arm Type
Experimental
Arm Description
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Arm Title
Anecortave Acetate 15 mg Depot
Arm Type
Experimental
Arm Description
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Arm Title
Anecortave Acetate 30 mg Depot
Arm Type
Experimental
Arm Description
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Arm Title
Anecortave Acetate Vehicle
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate Sterile Suspension, 6 mg/mL
Intervention Description
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate Suspension Depot, 30 mg/mL
Intervention Description
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate Sterile Suspension, 60 mg/mL
Intervention Description
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Intervention Type
Other
Intervention Name(s)
Anecortave Acetate Vehicle
Intervention Description
One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye
Primary Outcome Measure Information:
Title
Mean change in IOP at Week 4 from Baseline
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Either gender
18 years of age or older
IOP elevation caused by steroid usage
Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
Under 18 years of age
Other protocol-defined exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Landry
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
Facility Name
Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
San Paulo
City
San Paulo
Country
Brazil
Facility Name
Budapest
City
Budapest
Country
Hungary
Facility Name
Padova
City
Padova
Country
Italy
Facility Name
Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
Bayamon
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
Facility Name
Barcelona
City
Barcelona
Country
Spain
Facility Name
Newcastle upon Tyne
City
Newcastle upon Tyne
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation
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