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

Primary Purpose

Age Related Macular Degeneration, Diabetic Retinopathy

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Acetazolamide
Brimonidine tartarate
Anterior chamber paracentesis
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring intraocular pressure, bevacizumab, acetazolamide, brimonidine, anterior chamber paracentesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    1

    2

    3

    4

    Arm Description

    Patients submitted to 1,5 mg/0,06 ml intravitreal injection of bevacizumab and no treatment for intraocular pressure elevation

    Acetazolamide: 250 mg of oral acetazolamide 1 hour before intravitreal bevacizumab injection

    topic brimonidine tartarate: one drop of brimonidine tartarate 1 hour before intravitreal bevacizumab injection

    anterior chamber paracentesis: anterior chamber paracentesis immediately after intravitreal bevacizumab

    Outcomes

    Primary Outcome Measures

    Intraocular pressure (mmHg)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 18, 2009
    Last Updated
    March 18, 2009
    Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00864838
    Brief Title
    Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab
    Official Title
    Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    February 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Age Related Macular Degeneration, Diabetic Retinopathy
    Keywords
    intraocular pressure, bevacizumab, acetazolamide, brimonidine, anterior chamber paracentesis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    No Intervention
    Arm Description
    Patients submitted to 1,5 mg/0,06 ml intravitreal injection of bevacizumab and no treatment for intraocular pressure elevation
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Acetazolamide: 250 mg of oral acetazolamide 1 hour before intravitreal bevacizumab injection
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    topic brimonidine tartarate: one drop of brimonidine tartarate 1 hour before intravitreal bevacizumab injection
    Arm Title
    4
    Arm Type
    Experimental
    Arm Description
    anterior chamber paracentesis: anterior chamber paracentesis immediately after intravitreal bevacizumab
    Intervention Type
    Drug
    Intervention Name(s)
    Acetazolamide
    Other Intervention Name(s)
    Diamox
    Intervention Description
    250 mg 1 hour before intravitreal injection
    Intervention Type
    Drug
    Intervention Name(s)
    Brimonidine tartarate
    Other Intervention Name(s)
    Alphagan
    Intervention Description
    1 drop 1 hour before intravitreal injection
    Intervention Type
    Procedure
    Intervention Name(s)
    Anterior chamber paracentesis
    Intervention Description
    Immediately after bevacizumab injection
    Primary Outcome Measure Information:
    Title
    Intraocular pressure (mmHg)
    Time Frame
    1 hour and, 3 minutes before IVI. 3,10,20, 30 minutes after IVI

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rodrigo Jorge, MD
    Organizational Affiliation
    University of São Paulo
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Marco A Bonini-Filho, MD
    Organizational Affiliation
    University of São Paulo
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Bianka Y Katayama, MD
    Organizational Affiliation
    Clinic´s Hospital, Ribeirão Preto Medical School, University of São Paulo
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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