Back to resultsPars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA) (IBETRA)
Primary Purpose
Diabetic Retinopathy, Retinal Detachment
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Bevacizumab
pars plana vitrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Diabetic Retinopathy, Retinal detachment, Vitreous Hemorrhage, Bevacizumab, preoperative, pars plana vitrectomy
Eligibility Criteria
Inclusion Criteria:
- Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.
Exclusion Criteria:
- 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
Sites / Locations
- Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Preoperative Intravitreal bevacizumab and pars plana vitrectomy
Pars plana vitrectomy only
Outcomes
Primary Outcome Measures
amount of intraoperative intra-ocular bleeding
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00690768
Brief Title
Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)
Acronym
IBETRA
Official Title
Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Retinal Detachment
Keywords
Diabetic Retinopathy, Retinal detachment, Vitreous Hemorrhage, Bevacizumab, preoperative, pars plana vitrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Preoperative Intravitreal bevacizumab and pars plana vitrectomy
Arm Title
B
Arm Type
Active Comparator
Arm Description
Pars plana vitrectomy only
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 week after baseline; pars plana vitrectomy 3 weeks after baseline
Intervention Type
Procedure
Intervention Name(s)
pars plana vitrectomy
Intervention Description
pars plana vitrectomy 3 weeks after baseline
Primary Outcome Measure Information:
Title
amount of intraoperative intra-ocular bleeding
Time Frame
three weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.
Exclusion Criteria:
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
Facility Information:
Facility Name
Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
19208678
Citation
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.
Results Reference
derived
Learn more about this trial
Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)
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