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NCT00533962 Clinical Trial

IOP Reduction After Anecortave Acetate Injection in Glaucoma Patients

Glaucoma Clinical Trial

Official title:
Anterior Juxtascleral Depot of Anecortave Acetate: Intraocular Pressure Reduction in Glaucoma Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00533962
Other study ID # C-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 20, 2007
Last updated September 21, 2007
Start date August 2007

Study information
Verified date September 2007
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Anterior Juxtascleral Depot of Anecortave Acetate

Locations
Country Name City State
Brazil São Paulo São Paulo

Sponsors (2)
Lead Sponsor Collaborator
Federal University of São Paulo Alcon Research

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular pressure Procedure
Secondary Visual Acuity; side effects (biomicroscopy exam) Post treatment
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