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

NCT ID: NCT00745498

Last Updated: 2015-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Proliferative Diabetic Retinopathy Vitreous Hemorrhage

Keywords

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Proliferative diabetic retinopathy vitrectomy bevacizumab vitreous hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preop IVB

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 14 days before vitrectomy

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml)

Intraop IVB

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml)

No IVB

Patients will not receive bevacizumab before nor during vitrectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bevacizumab

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml)

Intervention Type DRUG

Other Intervention Names

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avastin

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kyu Hyung Park

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyu Hyung Park, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National Univeristy Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, Gyunggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 16829817 (View on PubMed)

Other Identifiers

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B-0801-053-004

Identifier Type: -

Identifier Source: org_study_id