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

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ClinicalTrials.gov Identifier: NCT00864838
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : March 19, 2009
Sponsor:
Collaborator:
Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP
Information provided by:
University of Sao Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Age Related Macular Degeneration Diabetic Retinopathy Drug: Acetazolamide Drug: Brimonidine tartarate Procedure: Anterior chamber paracentesis Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection
Study Start Date : June 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : March 2009


Arm Intervention/treatment
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




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00864838


Sponsors and Collaborators
University of Sao Paulo
Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP
Investigators
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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

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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
First Posted: March 19, 2009    Key Record Dates
Last Update Posted: March 19, 2009
Last Verified: March 2009

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

Additional relevant MeSH terms:
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Brimonidine Tartrate
Hypertension
Macular Degeneration
Diabetic Retinopathy
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Acetazolamide
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action