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NCT00804921 Clinical Trial

Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis in Intraocular Pressure (IOP) After 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: Preliminary Results

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00804921
Other study ID # IOP After Bevacizumab
Secondary ID
Status Completed
Phase Phase 2
First received December 8, 2008
Last updated December 8, 2008

Study information
Verified date December 2008
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

Purpose: To evaluate the effects of anterior chamber paracentesis, brimonidine and oral acetazolamide to reduce intra-ocular pressure (IOP) variations after intravitreal bevacizumab injection (IVBV).

Methods: 47 patients scheduled for IVBV (1.5 mg / 0.06 ml) will be randomly assigned to a pre-treatment 1 hour before IVBV with either 250 mg oral acetazolamide (DIA, 9 eyes), anterior chamber paracentesis immediate after IVBV (PAR, 15 eyes), topic brimonidine tartarate 1 hour before IVBV (BRI, 14 eyes), or no pre-treatment IBVB (CTR, 9 eyes). IOP will be measured 90 minutes before injection (baseline), just before injection, and at 3, 10, 20 and 30 minutes after the procedure.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- macular edema

Exclusion Criteria:

- pulmonary chronic problems

- chronic renal failure

- intraocular inflammation

- drug or alcohol addiction

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• bevacizumab

Procedure:
• anterior chamber paracentesis

Drug:
• acetazolamide

• brimonidine

Locations
Country Name City State
Brazil School of Medicine - Clinical Hospital Ribeirao Preto SP

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intra-ocular pressure variation after intra-vitreous injection of bevacizumab
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