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Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis in Intraocular Pressure (IOP) After Bevacizumab

Primary Purpose

Macular Edema, Diabetic Retinopathy, Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
bevacizumab
anterior chamber paracentesis
acetazolamide
brimonidine
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Macular Edema focused on measuring bevacizumab, intra-ocular pressure, acetazolamide, anterior chamber paracentesis, brimonidine, macular edema secondary to diabetic retinopathy or macular degeneration

Eligibility Criteria

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

Inclusion Criteria:

  • macular edema

Exclusion Criteria:

  • pulmonary chronic problems
  • chronic renal failure
  • intraocular inflammation
  • drug or alcohol addiction

Sites / Locations

  • School of Medicine - Clinical Hospital

Outcomes

Primary Outcome Measures

Intra-ocular pressure variation after intra-vitreous injection of bevacizumab

Secondary Outcome Measures

Full Information

First Posted
December 8, 2008
Last Updated
December 8, 2008
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00804921
Brief Title
Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis in Intraocular Pressure (IOP) After Bevacizumab
Official Title
Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection: Preliminary Results
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Purpose: To evaluate the effects of anterior chamber paracentesis, brimonidine and oral acetazolamide to reduce intra-ocular pressure (IOP) variations after intravitreal bevacizumab injection (IVBV). Methods: 47 patients scheduled for IVBV (1.5 mg / 0.06 ml) will be randomly assigned to a pre-treatment 1 hour before IVBV with either 250 mg oral acetazolamide (DIA, 9 eyes), anterior chamber paracentesis immediate after IVBV (PAR, 15 eyes), topic brimonidine tartarate 1 hour before IVBV (BRI, 14 eyes), or no pre-treatment IBVB (CTR, 9 eyes). IOP will be measured 90 minutes before injection (baseline), just before injection, and at 3, 10, 20 and 30 minutes after the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Diabetic Retinopathy, Macular Degeneration
Keywords
bevacizumab, intra-ocular pressure, acetazolamide, anterior chamber paracentesis, brimonidine, macular edema secondary to diabetic retinopathy or macular degeneration

7. Study Design

Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Type
Procedure
Intervention Name(s)
anterior chamber paracentesis
Intervention Type
Drug
Intervention Name(s)
acetazolamide
Intervention Type
Drug
Intervention Name(s)
brimonidine
Primary Outcome Measure Information:
Title
Intra-ocular pressure variation after intra-vitreous injection of bevacizumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: macular edema Exclusion Criteria: pulmonary chronic problems chronic renal failure intraocular inflammation drug or alcohol addiction
Facility Information:
Facility Name
School of Medicine - Clinical Hospital
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis in Intraocular Pressure (IOP) After Bevacizumab

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