IOP Reduction After Anecortave Acetate Injection in Glaucoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00533962
Recruitment Status : Unknown
Verified September 2007 by Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
First Posted : September 24, 2007
Last Update Posted : September 24, 2007
Alcon Research
Information provided by:
Federal University of São Paulo

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: Procedure ]

Secondary Outcome Measures :
  1. Visual Acuity; side effects (biomicroscopy exam) [ Time Frame: Post treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00533962

São Paulo
São Paulo, Brazil, 01404-001
Sponsors and Collaborators
Federal University of São Paulo
Alcon Research
Study Director: Tiago Prata Federal University of São Paulo Identifier: NCT00533962     History of Changes
Other Study ID Numbers: C-01
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: September 24, 2007
Last Verified: September 2007

Keywords provided by Federal University of São Paulo:
Anecortave Acetate
Intraocular pressure
Advanced glaucoma cases with uncontrolled IOP

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents