IOP Reduction After Anecortave Acetate Injection in Glaucoma Patients - Full Text View

Sponsors and Collaborators:	Federal University of São Paulo Alcon Research
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00533962

Purpose

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	Intervention
Glaucoma Intraocular Pressure	Drug: Anterior Juxtascleral Depot of Anecortave Acetate

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Anecortave acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Anterior Juxtascleral Depot of Anecortave Acetate: Intraocular Pressure Reduction in Glaucoma Patients

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

Intraocular pressure [ Time Frame: Procedure ]

Secondary Outcome Measures:

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

Enrollment:	30
Study Start Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533962

Locations

Brazil
São Paulo
São Paulo, Brazil, 01404-001

Sponsors and Collaborators

Federal University of São Paulo

Alcon Research

Investigators

Study Director:

Tiago Prata

Federal University of São Paulo

More Information

Study ID Numbers:	C-01
Study First Received:	September 20, 2007
Last Updated:	September 21, 2007
ClinicalTrials.gov Identifier:	NCT00533962
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:

Glaucoma
Anecortave Acetate
Intraocular pressure
Advanced glaucoma cases with uncontrolled IOP

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 16, 2009