IOP Reduction After Anecortave Acetate Injection in Glaucoma Patients
This trial is active, not recruiting.
|Conditions||glaucoma, intraocular pressure|
|Treatment||anterior juxtascleral depot of anecortave acetate|
|Sponsor||Federal University of São Paulo|
|Start date||August 2007|
|Trial size||30 participants|
|Trial identifier||NCT00533962, C-01|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: Procedure
Visual Acuity; side effects (biomicroscopy exam)
time frame: Post treatment
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
|Official title||Anterior Juxtascleral Depot of Anecortave Acetate: Intraocular Pressure Reduction in Glaucoma Patients|
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