Vitreous Hemorrhage Secondary to PDRPhase 2NCT01091896
Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage
A Phase 2 study testing Bevacizumab in people with Vitreous Hemorrhage Secondary to PDR, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without bevacizumab injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreous Hemorrhage Secondary to PDR
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Mar 2011
- 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
- patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy
Who cannot join
- follow-up period of less than 3 months
- not first vitrectomy
- abnormal blood coagulation
- uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
Hospital das Clínicas de Ribeirão Preto - USP contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas de Ribeirão Preto - University of São Paulo
Ribeirão Preto, São Paulo, 14049-990
Felipe Almeida, MD, 16 3602-2523 ext. 2523, felipeppalmeida@yahoo.com.br
Felipe Almeida, MD
About this study
Official title: Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage Secondary to Diabetic Retinopathy
The purpose of this study is to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without bevacizumab injection.
Read the detailed description
Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. We believe that preoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery
- Conditions
- Vitreous Hemorrhage Secondary to PDR
- Being tested
- Bevacizumab
- Keywords
- bevacizumab, vitreous hemorrhage, diabetes mellitus
- Medical subject headings
- Vitreous Hemorrhage, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
bevacizumabDrug
1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 - no bevacizumab | No intervention | Patients will not receive bevacizumab before nor during vitrectomy |
| 2- bevacizumab before vitrectomy | Experimental | Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy Receives: Drug: Bevacizumab |
| 3- bevacizumab after vitrectomy | Experimental | Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy Receives: Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent vitreous hemorrhage incidence after vitrectomy
Measured: 3 months
Secondary outcomes (1)
Visual outcome
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitreous Hemorrhage Secondary to PDRStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Felipe Almeida, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091896
- Sponsor's protocol ID
- IBEViH
- Other IDs
- IBEViH
- Status last verified
- Mar 2010
- First submitted
- 23 Mar 2010
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tonello M, Costa RA, Almeida FP, Barbosa JC, Scott IU, Jorge R. Panretinal photocoagulation versus PRP plus intravitreal bevacizumab for high-risk proliferative diabetic retinopathy (IBeHi study). Acta Ophthalmol. 2008 Jun;86(4):385-9. doi: 10.1111/j.1600-0420.2007.01056.x. Epub 2007 Nov 7.
PubMed 17995982Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4.
PubMed 37260074
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage Secondary to Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01091896
- Acronym / sponsor ID
- IBEViH
- Conditions
- Vitreous Hemorrhage Secondary to PDR
- Keywords
- bevacizumab, vitreous hemorrhage, diabetes mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 24 Mar 2010 (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 determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without bevacizumab injection.
Detailed description
Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. We believe that preoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 - no bevacizumab | No intervention | –Patients will not receive bevacizumab before nor during vitrectomy |
| 2- bevacizumab before vitrectomy | Experimental | Drug: BevacizumabPatients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy |
| 3- bevacizumab after vitrectomy | Experimental | Drug: bevacizumabPatients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy
Key exclusion criteria (4 listed)
- follow-up period of less than 3 months
- not first vitrectomy
- abnormal blood coagulation
- uncontrolled hypertension
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 |
|---|---|---|
| Bevacizumab1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy | Drug | 2- bevacizumab before vitrectomy |
| bevacizumab1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy | Drug | 3- bevacizumab after vitrectomy |
Primary outcome
Recurrent vitreous hemorrhage incidence after vitrectomy
Time frame: 3 months
1 secondary outcome
Visual outcome
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
- Background: PubMed 17995982Tonello M, Costa RA, Almeida FP, Barbosa JC, Scott IU, Jorge R. Panretinal photocoagulation versus PRP plus intravitreal bevacizumab for high-risk proliferative diabetic retinopathy (IBeHi study). Acta Ophthalmol. 2008 Jun;86(4):385-9. doi: 10.1111/j.1600-0420.2007.01056.x. Epub 2007 Nov 7.
- Derived from this study: PubMed 37260074Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4.
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.
Hospital das Clínicas de Ribeirão Preto - USP contact
Felipe Almeida, MD principal investigator
University of Sao Paulo
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 in people with Vitreous Hemorrhage Secondary to PDR, 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: status not confirmed, as of the sponsor's last update on 24 Mar 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hospital das Clínicas de Ribeirão Preto - USP, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent vitreous hemorrhage incidence after vitrectomy (time frame: 3 months). 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 NCT01091896, which also lists 2 linked publications.
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 24 Mar 2010.