Skip to main content
OpenTrials
Completed

NCT Number: NCT00745498

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

The purpose of this study is to determine the effect of pre- and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam, Gyunggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

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

Other names: avastin

Primary outcomes

  1. Recurrent VH Incidence (Early and Late)

    Time frame: 6 months

    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 outcomes

  1. Initial Time of Vitreous Clearing (ITVC)

    Time frame: 6 months

    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.

  2. Visual Outcome

    Time frame: 6 months

    Best-corrected visual acuity (BCVA) at postoperative 6 months

  3. Postoperative Resolution of Neovascularization

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Acronym: IBDV

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 3, 2008
Registry last updated
Dec 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.