Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab
This study has been completed.
Sponsor:
University of Sao Paulo
Collaborator:
Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00864838
First received: March 18, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Age Related Macular Degeneration Diabetic Retinopathy |
Drug: Acetazolamide Drug: Brimonidine tartarate Procedure: Anterior chamber paracentesis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Diabetic Eye Problems
High Blood Pressure
Macular Degeneration
Retinal Disorders
U.S. FDA Resources
Further study details as provided by University of Sao Paulo:
Primary Outcome Measures:
- Intraocular pressure (mmHg) [ Time Frame: 1 hour and, 3 minutes before IVI. 3,10,20, 30 minutes after IVI ] [ Designated as safety issue: Yes ]
| Enrollment: | 56 |
| Study Start Date: | June 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Patients submitted to 1,5 mg/0,06 ml intravitreal injection of bevacizumab and no treatment for intraocular pressure elevation
|
|
|
Experimental: 2
Acetazolamide: 250 mg of oral acetazolamide 1 hour before intravitreal bevacizumab injection
|
Drug: Acetazolamide
250 mg 1 hour before intravitreal injection
Other Name: Diamox
|
|
Experimental: 3
topic brimonidine tartarate: one drop of brimonidine tartarate 1 hour before intravitreal bevacizumab injection
|
Drug: Brimonidine tartarate
1 drop 1 hour before intravitreal injection
Other Name: Alphagan
|
|
Experimental: 4
anterior chamber paracentesis: anterior chamber paracentesis immediately after intravitreal bevacizumab
|
Procedure: Anterior chamber paracentesis
Immediately after bevacizumab injection
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864838
Sponsors and Collaborators
University of Sao Paulo
Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP
Investigators
| Study Chair: | Rodrigo Jorge, MD | University of São Paulo |
| Principal Investigator: | Marco A Bonini-Filho, MD | University of São Paulo |
| Study Director: | Bianka Y Katayama, MD | Clinic´s Hospital, Ribeirão Preto Medical School, University of São Paulo |
More Information
No publications provided
| Responsible Party: | Marco Antonio Bonini Filho, Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo |
| ClinicalTrials.gov Identifier: | NCT00864838 History of Changes |
| Other Study ID Numbers: | 4429/2008 |
| Study First Received: | March 18, 2009 |
| Last Updated: | March 18, 2009 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by University of Sao Paulo:
|
intraocular pressure bevacizumab acetazolamide brimonidine anterior chamber paracentesis |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Hypertension Macular Degeneration Ocular Hypertension Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases 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 Adrenergic Agonists |
ClinicalTrials.gov processed this record on May 19, 2013