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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

March 18, 2009
March 18, 2009
June 2008
February 2009   (final data collection date for primary outcome measure)
Intraocular pressure (mmHg) [ Time Frame: 1 hour and, 3 minutes before IVI. 3,10,20, 30 minutes after IVI ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab
Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Age Related Macular Degeneration
  • Diabetic Retinopathy
  • Drug: Acetazolamide
    250 mg 1 hour before intravitreal injection
    Other Name: Diamox
  • Drug: Brimonidine tartarate
    1 drop 1 hour before intravitreal injection
    Other Name: Alphagan
  • Procedure: Anterior chamber paracentesis
    Immediately after bevacizumab injection
  • 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
    Intervention: Drug: Acetazolamide
  • Experimental: 3
    topic brimonidine tartarate: one drop of brimonidine tartarate 1 hour before intravitreal bevacizumab injection
    Intervention: Drug: Brimonidine tartarate
  • Experimental: 4
    anterior chamber paracentesis: anterior chamber paracentesis immediately after intravitreal bevacizumab
    Intervention: Procedure: Anterior chamber paracentesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
March 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00864838
4429/2008
Yes
Marco Antonio Bonini Filho, Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
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
University of Sao Paulo
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP