Overview

This trial is active, not recruiting.

Conditions glaucoma, intraocular pressure
Treatment anterior juxtascleral depot of anecortave acetate
Sponsor Federal University of São Paulo
Collaborator Alcon Research
Start date August 2007
Trial size 30 participants
Trial identifier NCT00533962, C-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Intraocular pressure
time frame: Procedure

Secondary Outcomes

Measure
Visual Acuity; side effects (biomicroscopy exam)
time frame: Post treatment

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Anterior Juxtascleral Depot of Anecortave Acetate: Intraocular Pressure Reduction in Glaucoma Patients
Trial information was received from ClinicalTrials.gov and was last updated in September 2007.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.