Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy
Keywords
Abstract
Description
Postoperative vitreous hemorrhage(VH) is a common complication after vitrectomy for proliferative diabetic retinopathy. Persistent or recurrent VH can delay visual rehabilitation and give patients much trouble. There have been efforts to lower the incidence of postoperative VH such as using intraoperative gas tamponade and 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 intravitreal bevacizumab (IVB) injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful.Our hypothesis is that preoperative bevacizumab injection could reduce postoperative VH by way of decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative VH by inhibiting the vessel formation after surgery.
To prove our hypothesis, we started the prospective randomized comparative study to determine the effect of pre- and intra-operative IVB injection on postoperative vitreous hemorrhage after diabetic vitrectomy.
Dates
| Last Verified: | 10/31/2015 |
| First Submitted: | 09/01/2008 |
| Estimated Enrollment Submitted: | 09/01/2008 |
| First Posted: | 09/02/2008 |
| Last Update Submitted: | 11/16/2015 |
| Last Update Posted: | 12/20/2015 |
| Date of first submitted results: | 06/05/2012 |
| Date of first submitted QC results: | 11/16/2015 |
| Date of first posted results: | 12/20/2015 |
| Actual Study Start Date: | 05/31/2008 |
| Estimated Primary Completion Date: | 09/30/2010 |
| Estimated Study Completion Date: | 09/30/2010 |
Condition or disease
Intervention/treatment
Drug: Bevacizumab
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Preop IVB Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 14 days before vitrectomy | |
| Experimental: Intraop IVB Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy | |
| No Intervention: No IVB Patients will not receive bevacizumab before nor during vitrectomy |
Eligibility Criteria
| Ages Eligible for Study | 20 Years To 20 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Patients undergoing first vitrectomy for complications of proliferative diabetic retinopathy such as vitreous hemorrhage, tractional fibrovascular membrane proliferation, tractional or combined retinal detachment) Exclusion Criteria: - Follow-up period of less than 6 months - Intraoperative use of long-acting gas or silicone oil - Repeat vitrectomy after first vitrectomy for diseases other than vitreous hemorrhage - Not first vitrectomy - Uncontrolled hypertension - Medical history of abnormal blood coagulation - Time interval between IVB injection and PPV longer than 2 weeks and recent history (within 3 months) of IVB treatment |
Outcome
Primary Outcome Measures
1. Recurrent VH Incidence (Early and Late) [6 months]
Secondary Outcome Measures
1. Initial Time of Vitreous Clearing (ITVC) [6 months]
2. Visual Outcome [6 months]
3. Postoperative Resolution of Neovascularization [6 months]
