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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00804921
First received: December 8, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Macular Edema
Diabetic Retinopathy
Macular Degeneration
Drug: bevacizumab
Procedure: anterior chamber paracentesis
Drug: acetazolamide
Drug: brimonidine
Phase 2

Study Type: Interventional
Official Title: Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection: Preliminary Results

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Intra-ocular pressure variation after intra-vitreous injection of bevacizumab

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • macular edema

Exclusion Criteria:

  • pulmonary chronic problems
  • chronic renal failure
  • intraocular inflammation
  • drug or alcohol addiction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804921

Locations
Brazil
School of Medicine - Clinical Hospital
Ribeirao Preto, SP, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided

Responsible Party: CONEP (Comite Nacional de Etica em Pesquisa)
ClinicalTrials.gov Identifier: NCT00804921     History of Changes
Other Study ID Numbers: IOP After Bevacizumab
Study First Received: December 8, 2008
Last Updated: December 8, 2008
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
bevacizumab
intra-ocular pressure
acetazolamide
anterior chamber paracentesis
brimonidine
macular edema secondary to diabetic retinopathy or macular degeneration

Additional relevant MeSH terms:
Diabetic Retinopathy
Edema
Macular Degeneration
Macular Edema
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Retinal Degeneration
Acetazolamide
Brimonidine
Bevacizumab
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists

ClinicalTrials.gov processed this record on July 26, 2014