Vitreous Hemorrhage Secondary to PDR
Conditions
Keywords
bevacizumab, vitreous hemorrhage, diabetes mellitus
Brief 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.
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
Interventions
DRUGBevacizumab
1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
DRUGbevacizumab
1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrent vitreous hemorrhage incidence after vitrectomy | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Visual outcome | 3 months |
Countries
Brazil
Contacts
Primary ContactHospital das Clínicas de Ribeirão Preto - USP
Outcome results
None listed