Age Related Macular DegenerationPhase 2NCT00864838
Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab
A Phase 2 study testing Acetazolamide, Brimonidine tartarate and Anterior chamber paracentesis in people with Age Related Macular Degeneration and Diabetic Retinopathy, run by University of Sao Paulo.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age Related Macular Degeneration, Diabetic Retinopathy
- What is being tested?
- Acetazolamide, Brimonidine tartarate and Anterior chamber paracentesis
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of age related macular disease or diabetic retinopathy
- Able and willing to provide informed consent
Who cannot join
- 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
About this study
Official title: Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection
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.
- Being tested
- Acetazolamide, Brimonidine tartarate, Anterior chamber paracentesis
- Keywords
- intraocular pressure, bevacizumab, acetazolamide, brimonidine, anterior chamber paracentesis
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Also called Diamox
250 mg 1 hour before intravitreal injection
Brimonidine tartarateDrug
Also called Alphagan
1 drop 1 hour before intravitreal injection
Anterior chamber paracentesisProcedure or surgery
Immediately after bevacizumab injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Patients submitted to 1,5 mg/0,06 ml intravitreal injection of bevacizumab and no treatment for intraocular pressure elevation |
| 2 | Experimental | Acetazolamide: 250 mg of oral acetazolamide 1 hour before intravitreal bevacizumab injection Receives: Drug: Acetazolamide |
| 3 | Experimental | topic brimonidine tartarate: one drop of brimonidine tartarate 1 hour before intravitreal bevacizumab injection Receives: Drug: Brimonidine tartarate |
| 4 | Experimental | anterior chamber paracentesis: anterior chamber paracentesis immediately after intravitreal bevacizumab Receives: Procedure: Anterior chamber paracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (mmHg)
Measured: 1 hour and, 3 minutes before IVI. 3,10,20, 30 minutes after IVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startJun 2008
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP
- Investigators
- Rodrigo Jorge, MD, Study chair, University of Sao PauloMarco A Bonini-Filho, MD, Principal investigator, University of Sao PauloBianka Y Katayama, MD, Study director, Clinic´s Hospital, Ribeirão Preto Medical School, University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864838
- Sponsor's protocol ID
- 4429/2008
- Status last verified
- Mar 2009
- First submitted
- 18 Mar 2009
- Last updated
- 19 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection
- ClinicalTrials.gov ID
- NCT00864838
- Acronym / sponsor ID
- 4429/2008
- Keywords
- intraocular pressure, bevacizumab, acetazolamide, brimonidine, anterior chamber paracentesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP
- Study start
- Jun 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Patients submitted to 1,5 mg/0,06 ml intravitreal injection of bevacizumab and no treatment for intraocular pressure elevation |
| 2 | Experimental | Drug: AcetazolamideAcetazolamide: 250 mg of oral acetazolamide 1 hour before intravitreal bevacizumab injection |
| 3 | Experimental | Drug: Brimonidine tartaratetopic brimonidine tartarate: one drop of brimonidine tartarate 1 hour before intravitreal bevacizumab injection |
| 4 | Experimental | Procedure: Anterior chamber paracentesisanterior chamber paracentesis: anterior chamber paracentesis immediately after intravitreal bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of age related macular disease or diabetic retinopathy
- Able and willing to provide informed consent
Key exclusion criteria (7 listed)
- History of ocular hypertension or glaucoma
- High Myopes (> 6 spherical diopters)
- High Hyperopes (> 4 spherical diopters)
- Pulmonary disease
- Renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetazolamideAlso: Diamox250 mg 1 hour before intravitreal injection | Drug | 2 |
| Brimonidine tartarateAlso: Alphagan1 drop 1 hour before intravitreal injection | Drug | 3 |
| Anterior chamber paracentesisImmediately after bevacizumab injection | Procedure or surgery | 4 |
Primary outcome
Intraocular pressure (mmHg)
Time frame: 1 hour and, 3 minutes before IVI. 3,10,20, 30 minutes after IVI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2009.
Related trials for Age Related Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Jorge, MD study chair
University of Sao Paulo
Marco A Bonini-Filho, MD principal investigator
University of Sao Paulo
Bianka Y Katayama, MD study director
Clinic´s Hospital, Ribeirão Preto Medical School, University of São Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetazolamide, Brimonidine tartarate and Anterior chamber paracentesis in people with Age Related Macular Degeneration and Diabetic Retinopathy, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (mmHg) (time frame: 1 hour and, 3 minutes before IVI. 3,10,20, 30 minutes after IVI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2009.