Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy

Proliferative Diabetic Retinopathy Clinical Trial

— IBDV  

Official title:

Efficacy Study of Pre- and Intra-operative Intravitreal Bevacizumab Injection on Postoperative Vitreous Hemorrhage After Diabetic Vitrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745498
• Other study ID #: B-0801-053-004
• Status: Completed
• Phase: N/A
• First received: September 2, 2008
• Last updated: November 17, 2015
• Start date: June 2008
• Est. completion date: October 2010

Study information

• Verified date: November 2015
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Hemorrhage
• Proliferative Diabetic Retinopathy
• Retinal Diseases
• Vitreous Hemorrhage

Intervention

Drug:
• Bevacizumab
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyunggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Chen E, Park CH. Use of intravitreal bevacizumab as a preoperative adjunct for tractional retinal detachment repair in severe proliferative diabetic retinopathy. Retina. 2006 Jul-Aug;26(6):699-700. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent VH Incidence (Early and Late)	Recurrent VH was defined as a new episode of grade 1 or more VH occurring more than 1 week after surgery. "Early recurrent VH" was VH occurring <= 4 weeks and "late recurrent VH" was VH occurring >4 weeks after surgery.	6 months	No
Secondary	Initial Time of Vitreous Clearing (ITVC)	The interval in number of days for VH of grade 1 or more observed at postoperative day 1 to clear-up completely. VH of grade 1 was defined as mild vitreous hemorrhage with visible fundus details, but difficult to evaluate the retinal nerve fiber layer or small vessels.	6 months	No
Secondary	Visual Outcome	Best-corrected visual acuity (BCVA) at postoperative 6 months	6 months	No
Secondary	Postoperative Resolution of Neovascularization		6 months	No