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

NCT00804921 | Completed Phase 2 DMC

• 1 other identifier: IOP After Bevacizumab
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Macular Edema; Diabetic Retinopathy; Macular Degeneration

Keywords

bevacizumab; intra-ocular pressure; acetazolamide; anterior chamber paracentesis; brimonidine; macular edema secondary to diabetic retinopathy or macular degeneration

Outcome Measures

Primary Outcomes (1)

• Intra-ocular pressure variation after intra-vitreous injection of bevacizumab

Interventions

bevacizumab DRUG

anterior chamber paracentesis PROCEDURE

acetazolamide DRUG

brimonidine DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• macular edema

You may not qualify if:

• pulmonary chronic problems
• chronic renal failure
• intraocular inflammation
• drug or alcohol addiction

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Medicine - Clinical Hospital

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

MeSH Terms

Conditions

Macular Edema; Diabetic Retinopathy; Macular Degeneration

Interventions

Bevacizumab; 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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Last Updated: December 9, 2008

Record last verified: 2008-12

Locations

BR (1)