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NCT00864838 Clinical Trial

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

Diabetic Retinopathy Clinical Trial

Official title:
Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00864838
Other study ID # 4429/2008
Secondary ID
Status Completed
Phase Phase 2
First received March 18, 2009
Last updated March 18, 2009
Start date June 2008
Est. completion date March 2009

Study information
Verified date March 2009
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date March 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Acetazolamide
250 mg 1 hour before intravitreal injection
• Brimonidine tartarate
1 drop 1 hour before intravitreal injection
Procedure:
• Anterior chamber paracentesis
Immediately after bevacizumab injection

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of Sao Paulo Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular pressure (mmHg) 1 hour and, 3 minutes before IVI. 3,10,20, 30 minutes after IVI Yes
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