IOP Reduction After Anecortave Acetate Injection in Glaucoma Patients

Sponsor

Federal University of São Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT00533962

Collaborator

Alcon Research (Industry)

Enrollment

Location

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Intraocular Pressure	Drug: Anterior Juxtascleral Depot of Anecortave Acetate	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Intraocular pressure [Procedure]

Secondary Outcome Measures

Visual Acuity; side effects (biomicroscopy exam) [Post treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)