IOP Reduction After Anecortave Acetate Injection in Glaucoma Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Alcon Research
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00533962
First received: September 20, 2007
Last updated: September 21, 2007
Last verified: September 2007
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anterior Juxtascleral Depot of Anecortave Acetate: Intraocular Pressure Reduction in Glaucoma Patients

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00533962     History of Changes
Other Study ID Numbers: C-01
Study First Received: September 20, 2007
Last Updated: September 21, 2007
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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014