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

March 18, 2009 updated by: University of Sao Paulo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Alphagan
Experimental: 4
anterior chamber paracentesis: anterior chamber paracentesis immediately after intravitreal bevacizumab
Procedure: Anterior chamber paracentesis
Immediately after bevacizumab injection

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP

Investigators

  • Principal Investigator: Marco A Bonini-Filho, MD, University of Sao Paulo
  • Study Director: Bianka Y Katayama, MD, Clinic´s Hospital, Ribeirão Preto Medical School, University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

March 18, 2009

First Submitted That Met QC Criteria

March 18, 2009

First Posted (Estimate)

March 19, 2009

Study Record Updates

Last Update Posted (Estimate)

March 19, 2009

Last Update Submitted That Met QC Criteria

March 18, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4429/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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