Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage
Keywords
Abstract
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
Dates
| Last Verified: | 02/28/2010 |
| First Submitted: | 03/22/2010 |
| Estimated Enrollment Submitted: | 03/22/2010 |
| First Posted: | 03/23/2010 |
| Last Update Submitted: | 03/22/2010 |
| Last Update Posted: | 03/23/2010 |
| Actual Study Start Date: | 12/31/2009 |
| Estimated Primary Completion Date: | 08/31/2010 |
| Estimated Study Completion Date: | 02/28/2011 |
Condition or disease
Intervention/treatment
Drug: 2- bevacizumab before vitrectomy
Drug: 3- bevacizumab after vitrectomy
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| No Intervention: 1 - no bevacizumab Patients will not receive bevacizumab before nor during vitrectomy | |
| Experimental: 2- bevacizumab before vitrectomy Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy | Drug: 2- bevacizumab before vitrectomy 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy |
| Experimental: 3- bevacizumab after vitrectomy Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy | Drug: 3- bevacizumab after vitrectomy 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Recurrent vitreous hemorrhage incidence after vitrectomy [3 months]
Secondary Outcome Measures
1. Visual outcome [3 months]
