Diabetic RetinopathyPhase 2IBETRANCT00690768
Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)
A Phase 2 study testing Bevacizumab and pars plana vitrectomy in people with Diabetic Retinopathy and Retinal Detachment, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Retinopathy, Retinal Detachment
- What is being tested?
- Bevacizumab and pars plana vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to May 2008
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.
Who cannot join
- Massive vitreous hemorrhage preventing from detailed posterior pole examination;
- Previous intra-ocular surgery other than cataract surgery
- Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin
- Prothrombin time, partial thromboplastin time or platelet count without normal limits
- History of previous thromboembolic events
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)
The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment.
- Conditions
- Diabetic Retinopathy, Retinal Detachment
- Being tested
- Bevacizumab, pars plana vitrectomy
- Keywords
- Diabetic Retinopathy, Retinal detachment, Vitreous Hemorrhage, Bevacizumab, preoperative, pars plana vitrectomy
- Medical subject headings
- Diabetic Retinopathy, Retinal Detachment, Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 week after baseline; pars plana vitrectomy 3 weeks after baseline
pars plana vitrectomyProcedure or surgery
pars plana vitrectomy 3 weeks after baseline
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Preoperative Intravitreal bevacizumab and pars plana vitrectomy Receives: Drug: Bevacizumab; Procedure: pars plana vitrectomy |
| B | Active comparator | Pars plana vitrectomy only Receives: Procedure: pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of intraoperative intra-ocular bleeding
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690768
- Sponsor's protocol ID
- IBETRA
- Acronym
- IBETRA
- Status last verified
- May 2008
- First submitted
- 30 May 2008
- Last updated
- 5 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
da R Lucena D, Ribeiro JA, Costa RA, Barbosa JC, Scott IU, de Figueiredo-Pontes LL, Jorge R. Intraoperative bleeding during vitrectomy for diabetic tractional retinal detachment with versus without preoperative intravitreal bevacizumab (IBeTra study). Br J Ophthalmol. 2009 May;93(5):688-91. doi: 10.1136/bjo.2008.151233. Epub 2009 Feb 10.
PubMed 19208678
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)
- ClinicalTrials.gov ID
- NCT00690768
- Acronym / sponsor ID
- IBETRA / IBETRA
- Conditions
- Diabetic Retinopathy, Retinal Detachment
- Keywords
- Diabetic Retinopathy, Retinal detachment, Vitreous Hemorrhage, Bevacizumab, preoperative, pars plana vitrectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 5 Jun 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.
The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Bevacizumab, Procedure: pars plana vitrectomyPreoperative Intravitreal bevacizumab and pars plana vitrectomy |
| B | Active comparator | Procedure: pars plana vitrectomyPars plana vitrectomy only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.
Key exclusion criteria (5 listed)
- Massive vitreous hemorrhage preventing from detailed posterior pole examination;
- Previous intra-ocular surgery other than cataract surgery
- Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin
- Prothrombin time, partial thromboplastin time or platelet count without normal limits
- History of previous thromboembolic events
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 |
|---|---|---|
| BevacizumabAlso: AvastinIntravitreal bevacizumab (1.5 mg; 0,06 ml) 1 week after baseline; pars plana vitrectomy 3 weeks after baseline | Drug | A |
| pars plana vitrectomypars plana vitrectomy 3 weeks after baseline | Procedure or surgery | A, B |
Primary outcome
amount of intraoperative intra-ocular bleeding
Time frame: three weeks
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 5 Jun 2008.
- Derived from this study: PubMed 19208678da R Lucena D, Ribeiro JA, Costa RA, Barbosa JC, Scott IU, de Figueiredo-Pontes LL, Jorge R. Intraoperative bleeding during vitrectomy for diabetic tractional retinal detachment with versus without preoperative intravitreal bevacizumab (IBeTra study). Br J Ophthalmol. 2009 May;93(5):688-91. doi: 10.1136/bjo.2008.151233. Epub 2009 Feb 10.
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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 and pars plana vitrectomy in people with Diabetic Retinopathy and Retinal Detachment, 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 5 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 5 Jun 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?
amount of intraoperative intra-ocular bleeding (time frame: three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00690768, which also lists 1 linked publication.
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 5 Jun 2008.