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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyu Hyung Park, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00745498
First received: September 2, 2008
Last updated: November 17, 2015
Last verified: November 2015
  Purpose
The purpose of this study is to determine the effect of pre- and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy.

Condition Intervention
Proliferative Diabetic Retinopathy
Vitreous Hemorrhage
Drug: Bevacizumab

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy Study of Pre- and Intra-operative Intravitreal Bevacizumab Injection on Postoperative Vitreous Hemorrhage After Diabetic Vitrectomy

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Recurrent VH Incidence (Early and Late) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Best-corrected visual acuity (BCVA) at postoperative 6 months

  • Postoperative Resolution of Neovascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: June 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preop IVB
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 14 days before vitrectomy
Drug: Bevacizumab
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml)
Other Name: avastin
Experimental: Intraop IVB
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
Drug: Bevacizumab
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml)
Other Name: avastin
No Intervention: No IVB
Patients will not receive bevacizumab before nor during 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

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745498

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyunggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Kyu Hyung Park, M.D. Seoul National Univeristy Bundang Hospital
  More Information

Publications:
Responsible Party: Kyu Hyung Park, Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00745498     History of Changes
Other Study ID Numbers: B-0801-053-004 
Study First Received: September 2, 2008
Results First Received: June 6, 2012
Last Updated: November 17, 2015
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
Proliferative diabetic retinopathy
vitrectomy
bevacizumab
vitreous hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Retinal Diseases
Diabetic Retinopathy
Vitreous Hemorrhage
Pathologic Processes
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eye Hemorrhage
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 29, 2016