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

Phase 2

Completed

• Conditions: Age Related Macular Degeneration; Diabetic Retinopathy
• Interventions: Drug: Acetazolamide; Drug: Brimonidine tartarate; Procedure: Anterior chamber paracentesis

• Registration Number: NCT00864838
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2009-02
• Status Verified: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2009-03-18
• Study First Submitted QC: 2009-03-18
• Last Update Submitted: 2009-03-18
• Study First Posted: 2009-03-19
• Last Update Posted: 2009-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Acetazolamide	Acetazolamide: 250 mg of oral acetazolamide 1 hour before intravitreal bevacizumab injection
3	Brimonidine tartarate	topic brimonidine tartarate: one drop of brimonidine tartarate 1 hour before intravitreal bevacizumab injection
4	Anterior chamber paracentesis	anterior chamber paracentesis: anterior chamber paracentesis immediately after intravitreal bevacizumab

Primary Outcome Measures

Name	Time	Method
Intraocular pressure (mmHg)	1 hour and, 3 minutes before IVI. 3,10,20, 30 minutes after IVI