- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01151722
Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage (ABeVi)
Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. There have been efforts to lower the incidence of postoperative vitreous hemorrhage such as preoperative bevacizumab injection. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. Recently there have been reports showing that preoperative bevacizumab injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful. Our hypothesis is that intraoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery.
We started the prospective randomized comparative study to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without any adjuvant drug.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Felipe Almeida
- Email: felipeppalmeida@yahoo.com.br
Study Locations
-
-
Sao Paulo
-
Ribeirão Preto, Sao Paulo, Brazil, 14049-990
- Recruiting
- Hospital das Clínicas de Ribeirão Preto - University of São Paulo
-
Contact:
- Felipe Almeida, MD
- Phone Number: 2523 16 3602-2523
- Email: felipeppalmeida@yahoo.com.br
-
Principal Investigator:
- Felipe Almeida, MD
-
Contact:
- Felipe Almeida
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy
Exclusion Criteria:
- follow-up period of less than 3 months
- not first vitrectomy
- abnormal blood coagulation
- uncontrolled hypertension
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: no injection
no bevacizumab
|
|
EXPERIMENTAL: experimental 2
bevacizumab before vitrectomy
|
bevacizumab injection before vitrectomy
bevacizumab injection after vitrectomy
|
EXPERIMENTAL: experimental 3
bevacizumab after vitrectomy
|
bevacizumab injection before vitrectomy
bevacizumab injection after vitrectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Vitreous hemorrhage recurrence
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCRP22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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