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

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


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

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
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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
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

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
anterior chamber paracentesis

Additional relevant MeSH terms:
Diabetic Retinopathy
Macular Degeneration
Ocular Hypertension
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Retinal Degeneration
Retinal Diseases
Vascular Diseases
Brimonidine Tartrate
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antihypertensive Agents
Antineoplastic Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 26, 2016