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

NCT00864838 | Completed Phase 2 DMC

• 1 other identifier: 4429/2008
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Age Related Macular Degeneration; Diabetic Retinopathy

Keywords

intraocular pressure; bevacizumab; acetazolamide; brimonidine; anterior chamber paracentesis

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure (mmHg)

  1 hour and, 3 minutes before IVI. 3,10,20, 30 minutes after IVI

Study Arms (4)

1

NO INTERVENTION

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

2

EXPERIMENTAL

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

Drug: Acetazolamide

3

EXPERIMENTAL

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

Drug: Brimonidine tartarate

4

EXPERIMENTAL

anterior chamber paracentesis: anterior chamber paracentesis immediately after intravitreal bevacizumab

Procedure: Anterior chamber paracentesis

Interventions

Acetazolamide DRUG

250 mg 1 hour before intravitreal injection

Also known as: Diamox

2

Brimonidine tartarate DRUG

1 drop 1 hour before intravitreal injection

Also known as: Alphagan

3

Anterior chamber paracentesis PROCEDURE

Immediately after bevacizumab injection

4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of age related macular disease or diabetic retinopathy
• Able and willing to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP: collaborator

MeSH Terms

Conditions

Macular Degeneration; Diabetic Retinopathy

Interventions

Acetazolamide; Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Rodrigo Jorge, MD

  University of Sao Paulo

  STUDY CHAIR

• Marco A Bonini-Filho, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Bianka Y Katayama, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 18, 2009
• First Posted: March 19, 2009
• Study Start: June 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 19, 2009

Record last verified: 2009-03