Clinical trial NCT00745498: Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy
Official title: Efficacy Study of Pre- and Intra-operative Intravitreal Bevacizumab Injection on Postoperative Vitreous Hemorrhage After Diabetic Vitrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proliferative Diabetic Retinopathy
Vitreous Hemorrhage
Keywords: Proliferative diabetic retinopathy
vitrectomy
bevacizumab
vitreous hemorrhage
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Recurrent VH Incidence (Early and Late)
timeFrame: 6 months
Secondary outcomes:
measure: Initial Time of Vitreous Clearing (ITVC)
timeFrame: 6 months
measure: Visual Outcome
timeFrame: 6 months
measure: Postoperative Resolution of Neovascularization
timeFrame: 6 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyunggi-do
Study officials:
affiliation: Seoul National Univeristy Bundang Hospital
name: Kyu Hyung Park, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/01.iae.0000225351.87205.69. No abstract available.