Macular EdemaPhase 2NCT00804921
Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis in Intraocular Pressure (IOP) After Bevacizumab
A Phase 2 study testing bevacizumab, anterior chamber paracentesis and acetazolamide in people with Macular Edema and Diabetic Retinopathy, run by University of Sao Paulo at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Edema, Diabetic Retinopathy, Macular Degeneration
- What is being tested?
- bevacizumab, anterior chamber paracentesis and acetazolamide
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Start not givento not given
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- macular edema
Who cannot join
- pulmonary chronic problems
- chronic renal failure
- intraocular inflammation
- drug or alcohol addiction
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Medicine - Clinical Hospital
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection: Preliminary Results
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
- Being tested
- bevacizumab, anterior chamber paracentesis, acetazolamide, brimonidine
- Keywords
- bevacizumab, intra-ocular pressure, acetazolamide, anterior chamber paracentesis, brimonidine, macular edema secondary to diabetic retinopathy or macular degeneration
- Medical subject headings
- Macular Edema, Diabetic Retinopathy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
anterior chamber paracentesisProcedure or surgery
acetazolamideDrug
brimonidineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-ocular pressure variation after intra-vitreous injection of bevacizumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies 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
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804921
- Sponsor's protocol ID
- IOP After Bevacizumab
- Status last verified
- Dec 2008
- First submitted
- 8 Dec 2008
- Last updated
- 9 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2008. 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: Preliminary Results
- ClinicalTrials.gov ID
- NCT00804921
- Acronym / sponsor ID
- IOP After Bevacizumab
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- First posted
- 9 Dec 2008 (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.
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.
Study design
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- macular edema
Key exclusion criteria (4 listed)
- pulmonary chronic problems
- chronic renal failure
- intraocular inflammation
- drug or alcohol addiction
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 |
|---|---|---|
| bevacizumab | Drug | – |
| anterior chamber paracentesis | Procedure or surgery | – |
| acetazolamide | Drug | – |
| brimonidine | Drug | – |
Primary outcome
Intra-ocular pressure variation after intra-vitreous injection of bevacizumab
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 9 Dec 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab, anterior chamber paracentesis and acetazolamide in people with Macular Edema and Diabetic Retinopathy, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 4 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 9 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Intra-ocular pressure variation after intra-vitreous injection of bevacizumab. 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 9 Dec 2008; AzTrials last refreshed its copy on 8 Nov 2026.