Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab

This study has been completed.
Sponsor:
Collaborator:
Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00864838
First received: March 18, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

The purpose of this study is to evaluate the effects of anterior chamber paracentesis, brimonidine and oral acetazolamide to reduce intra-ocular pressure variations after intravitreal bevacizumab injection.


Condition Intervention Phase
Age Related Macular Degeneration
Diabetic Retinopathy
Drug: Acetazolamide
Drug: Brimonidine tartarate
Procedure: Anterior chamber paracentesis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Intraocular pressure (mmHg) [ Time Frame: 1 hour and, 3 minutes before IVI. 3,10,20, 30 minutes after IVI ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: June 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Patients submitted to 1,5 mg/0,06 ml intravitreal injection of bevacizumab and no treatment for intraocular pressure elevation
Experimental: 2
Acetazolamide: 250 mg of oral acetazolamide 1 hour before intravitreal bevacizumab injection
Drug: Acetazolamide
250 mg 1 hour before intravitreal injection
Other Name: Diamox
Experimental: 3
topic brimonidine tartarate: one drop of brimonidine tartarate 1 hour before intravitreal bevacizumab injection
Drug: Brimonidine tartarate
1 drop 1 hour before intravitreal injection
Other Name: Alphagan
Experimental: 4
anterior chamber paracentesis: anterior chamber paracentesis immediately after intravitreal bevacizumab
Procedure: Anterior chamber paracentesis
Immediately after bevacizumab injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of age related macular disease or diabetic retinopathy
  • Able and willing to provide informed consent

Exclusion Criteria:

  • History of ocular hypertension or glaucoma
  • High Myopes (> 6 spherical diopters)
  • High Hyperopes (> 4 spherical diopters)
  • Pulmonary disease
  • Renal disease
  • Known allergy to any component of the study drug
  • Myocardial infarction, transient ischemic attack within 4 months prior to randomization or any contraindication for bevacizumab use
  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: NCT00864838

Sponsors and Collaborators
University of Sao Paulo
Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP
Investigators
Study Chair: Rodrigo Jorge, MD University of São Paulo
Principal Investigator: Marco A Bonini-Filho, MD University of São Paulo
Study Director: Bianka Y Katayama, MD Clinic´s Hospital, Ribeirão Preto Medical School, University of São Paulo
  More Information

No publications provided

Responsible Party: Marco Antonio Bonini Filho, Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
ClinicalTrials.gov Identifier: NCT00864838     History of Changes
Other Study ID Numbers: 4429/2008
Study First Received: March 18, 2009
Last Updated: March 18, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
intraocular pressure
bevacizumab
acetazolamide
brimonidine
anterior chamber paracentesis

Additional relevant MeSH terms:
Diabetic Retinopathy
Hypertension
Macular Degeneration
Ocular Hypertension
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Retinal Degeneration
Acetazolamide
Brimonidine
Bevacizumab
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on July 24, 2014