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

NCT ID: NCT00864838

Last Updated: 2009-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Age Related Macular Degeneration Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

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

Group Type NO_INTERVENTION

No interventions assigned to this group

2

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

Group Type EXPERIMENTAL

Acetazolamide

Intervention Type DRUG

250 mg 1 hour before intravitreal injection

3

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

Group Type EXPERIMENTAL

Brimonidine tartarate

Intervention Type DRUG

1 drop 1 hour before intravitreal injection

4

anterior chamber paracentesis: anterior chamber paracentesis immediately after intravitreal bevacizumab

Group Type EXPERIMENTAL

Anterior chamber paracentesis

Intervention Type PROCEDURE

Immediately after bevacizumab injection

Interventions

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Acetazolamide

250 mg 1 hour before intravitreal injection

Intervention Type DRUG

Brimonidine tartarate

1 drop 1 hour before intravitreal injection

Intervention Type DRUG

Anterior chamber paracentesis

Immediately after bevacizumab injection

Intervention Type PROCEDURE

Other Intervention Names

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Diamox Alphagan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP

UNKNOWN

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Principal Investigators

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Rodrigo Jorge, MD

Role: STUDY_CHAIR

University of Sao Paulo

Marco A Bonini-Filho, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Bianka Y Katayama, MD

Role: STUDY_DIRECTOR

Clinic´s Hospital, Ribeirão Preto Medical School, University of São Paulo

Other Identifiers

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4429/2008

Identifier Type: -

Identifier Source: org_study_id

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