IOP Reduction After Anecortave Acetate Injection in Glaucoma Patients
Primary Purpose
Glaucoma, Intraocular Pressure
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Anterior Juxtascleral Depot of Anecortave Acetate
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Anecortave Acetate, Intraocular pressure, Advanced glaucoma cases with uncontrolled IOP
Eligibility Criteria
Inclusion Criteria:
- Advanced glaucoma cases with surgery or cyclophotocoagulation indication (IOP over 25 mmHg)
- Patients should be under maximum tolerated medication
- Low best corrected visual acuity (worse than 20/100)
Exclusion Criteria:
- Under 18 or over 80
Sites / Locations
- São Paulo
Outcomes
Primary Outcome Measures
Intraocular pressure
Secondary Outcome Measures
Visual Acuity; side effects (biomicroscopy exam)
Full Information
NCT ID
NCT00533962
First Posted
September 20, 2007
Last Updated
September 21, 2007
Sponsor
Federal University of São Paulo
Collaborators
Alcon Research
1. Study Identification
Unique Protocol Identification Number
NCT00533962
Brief Title
IOP Reduction After Anecortave Acetate Injection in Glaucoma Patients
Official Title
Anterior Juxtascleral Depot of Anecortave Acetate: Intraocular Pressure Reduction in Glaucoma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
Collaborators
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Introduction: Ocular administration of glucocorticoids is a common and effective treatment for several ocular diseases. However it is often complicated with the elevation of intraocular pressure (IOP). Anecortave acetate (AA) is an analog of cortisol acetate and lacks the typical anti-inflammatory and immunosuppressive properties of glucocorticoids. The effect of its anterior juxtascleral depot (AJD) injection has been evaluated in cases of glaucoma caused by intravitreal triamcinolone acetonide, presenting impressive results. The purpose of this study is to evaluate the efficacy and safety of the AA injection as a possible antiglaucoma treatment alternative. Methods: A prospective clinical study will be carried out including 30 glaucoma patients (30 eyes). After inclusion each patient will receive a single AJD injection of 30 mg of AA in the selected eye. Main outcome measure include: intraocular pressure at 1st day, 7th day, 1st, 2nd and 3rd months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Intraocular Pressure
Keywords
Glaucoma, Anecortave Acetate, Intraocular pressure, Advanced glaucoma cases with uncontrolled IOP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Anterior Juxtascleral Depot of Anecortave Acetate
Primary Outcome Measure Information:
Title
Intraocular pressure
Time Frame
Procedure
Secondary Outcome Measure Information:
Title
Visual Acuity; side effects (biomicroscopy exam)
Time Frame
Post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Advanced glaucoma cases with surgery or cyclophotocoagulation indication (IOP over 25 mmHg)
Patients should be under maximum tolerated medication
Low best corrected visual acuity (worse than 20/100)
Exclusion Criteria:
Under 18 or over 80
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiago Prata
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
São Paulo
City
São Paulo
ZIP/Postal Code
01404-001
Country
Brazil
12. IPD Sharing Statement
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IOP Reduction After Anecortave Acetate Injection in Glaucoma Patients
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