Seoul National University Bundang Hospital
Seongnam, Gyunggi-do, 463-707, South Korea
NCT Number: NCT00745498
The purpose of this study is to determine the effect of pre- and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy.
Looking for future studies?
Notify Me20 year and older
All sexes
Interventional
Not applicable
Seongnam, Gyunggi-do, 463-707, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml)
Other names: avastin
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.
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.
Time frame: 6 months
Best-corrected visual acuity (BCVA) at postoperative 6 months
Time frame: 6 months
Seoul National University Bundang Hospital
Other
Efficacy Study of Pre- and Intra-operative Intravitreal Bevacizumab Injection on Postoperative Vitreous Hemorrhage After Diabetic Vitrectomy
Acronym: IBDV
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.
NCT02858076
Eye Diseases, Eye Hemorrhage
Campbell, California, United States
View Trial DetailsNCT00996437
Eye Diseases, Eye Hemorrhage
Phoenix, Arizona, United States
View Trial DetailsNCT01854593
Diabetic Traction Retinal Detachment, Eye Diseases
Tokyo, Japan
View Trial DetailsNCT01724385
Eye Diseases, Eye Hemorrhage
Khon Kaen, Changwat Khon Kaen, Thailand
View Trial Details