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

U

University of Sao Paulo

Status and phase

Completed
Phase 2

Conditions

Age Related Macular Degeneration
Diabetic Retinopathy

Treatments

Drug: Brimonidine tartarate
Procedure: Anterior chamber paracentesis
Drug: Acetazolamide

Study type

Interventional

Funder types

Other

Identifiers

NCT00864838
4429/2008

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

56 participants in 4 patient groups

1
No Intervention group
Description:
Patients submitted to 1,5 mg/0,06 ml intravitreal injection of bevacizumab and no treatment for intraocular pressure elevation
2
Experimental group
Description:
Acetazolamide: 250 mg of oral acetazolamide 1 hour before intravitreal bevacizumab injection
Treatment:
Drug: Acetazolamide
3
Experimental group
Description:
topic brimonidine tartarate: one drop of brimonidine tartarate 1 hour before intravitreal bevacizumab injection
Treatment:
Drug: Brimonidine tartarate
4
Experimental group
Description:
anterior chamber paracentesis: anterior chamber paracentesis immediately after intravitreal bevacizumab
Treatment:
Procedure: Anterior chamber paracentesis

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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