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Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy (IBDV)

Primary Purpose

Proliferative Diabetic Retinopathy, Vitreous Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Proliferative diabetic retinopathy, vitrectomy, bevacizumab, vitreous hemorrhage

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Preop IVB

Intraop IVB

No IVB

Arm Description

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

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

Patients will not receive bevacizumab before nor during vitrectomy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Visual Outcome
Best-corrected visual acuity (BCVA) at postoperative 6 months
Postoperative Resolution of Neovascularization

Full Information

First Posted
September 2, 2008
Last Updated
November 17, 2015
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00745498
Brief Title
Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy
Acronym
IBDV
Official Title
Efficacy Study of Pre- and Intra-operative Intravitreal Bevacizumab Injection on Postoperative Vitreous Hemorrhage After Diabetic Vitrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy, Vitreous Hemorrhage
Keywords
Proliferative diabetic retinopathy, vitrectomy, bevacizumab, vitreous hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preop IVB
Arm Type
Experimental
Arm Description
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 14 days before vitrectomy
Arm Title
Intraop IVB
Arm Type
Experimental
Arm Description
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
Arm Title
No IVB
Arm Type
No Intervention
Arm Description
Patients will not receive bevacizumab before nor during vitrectomy
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
avastin
Intervention Description
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml)
Primary Outcome Measure Information:
Title
Recurrent VH Incidence (Early and Late)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Initial Time of Vitreous Clearing (ITVC)
Description
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.
Time Frame
6 months
Title
Visual Outcome
Description
Best-corrected visual acuity (BCVA) at postoperative 6 months
Time Frame
6 months
Title
Postoperative Resolution of Neovascularization
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu Hyung Park, M.D.
Organizational Affiliation
Seoul National Univeristy Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyunggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
16829817
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.
Results Reference
background

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

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