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Bevacizumab and Long Acting Gas in Diabetic Vitrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00656435
Recruitment Status : Completed
First Posted : April 11, 2008
Last Update Posted : April 11, 2008
Information provided by:
National Taiwan University Hospital

Brief Summary:

Persistent or recurrent vitreous hemorrhage after vitrectomy for diabetic retinopathy complications is a common occurrence with an incidence of 12% to 63%. This complication may prolong vitreous clear-up and delay visual rehabilitation significantly, and sometimes requires additional procedures or surgery.

The causes of bleeding are diverse. Evidence suggests fibrovascular proliferation from the sclerotomy sites or from the vitreous base may be an important source of recurrent vitreous hemorrhage; other sources of bleeding include iatrogenic intraoperative injury of retinal vessels, and incomplete removal of fibrovascular tissues.

We have reported on the possible benefit of peripheral retinal cryotherapy and cryotherapy treatment of sclerotomy sites to prevent delayed-onset recurrent vitreous hemorrhage, and the possible benefit of intravitreal long-acting gas to reduce the occurrence of early postoperative recurrent vitreous hemorrhage, especially for cases with active fibrovascular proliferation. However, minor recurrent vitreous hemorrhage and prolonged reabsorption of lysed blood clots from surgical trauma remain important factors to cause media opacity long enough to prevent quick visual rehabilitation.

Intravitreal bevacizumab has been noted to induce rapid regression of retinal and iris neovascularization in proliferative diabetic retinopathy. Further, presurgical administration of intravitreal bevacizumab may reduce intraoperative bleeding during membrane dissection in PDR with traction retinal detachment. We hypothesize that presurgical treatment of intravitreal bevacizumab may reduce intraoperative bleeding and the amount of residual blood clots, while intraoperative infusion of long-acting gas may facilitate post-operative recovery of surgically injured retinal vessels. These combined effects would thus enhance early clear-up of vitreous opacity from clot lysis and recurrent retinal bleeding. To investigate this hypothesis, a clinical prospective study was undertaken to evaluate the effects of bevacizumab pretreatment combined with intravitreal infusion of long-acting gas on the clearance speed and the recurrence rate of early postoperative vitreous hemorrhage in vitrectomy for active diabetic fibrovascular proliferation.

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Drug: Bevacizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bevacizumab Pretreatment and Long Acting Gas Infusion on the Vitreous Clear-up After Diabetic Vitrectomy
Study Start Date : December 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: A
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy
Drug: Bevacizumab
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy
Other Name: Avastin

No Intervention: B
Patients will not receive bevacizumab pretreatment

Primary Outcome Measures :
  1. The severity of intraoperative bleeding and vitreous clear-up time. [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Percentage of prolonged vitreous clear-up (≥ 3 weeks) and recurrent hemorrhage rate. [ Time Frame: Six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. anticoagulant therapy has not been used prior to surgery or during post-operative follow-up period.
  2. no medical history of blood diseases associated with abnormal blood coagulation is present.
  3. Having active fibrovascular proliferation with vitreo-retinal adhesions in 3 or more sites but not extending beyond the equator in more than one quadrant.
  4. Severe retinopathy with anticipation of silicone oil usag
  5. Age is between 20 to 85 years old.

Exclusion Criteria:

  1. Not primary pars plana vitrectomy
  2. post-operative follow-up duration less than three months
  3. Pregnancy
  4. HbA1c > 8.0

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00656435

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Department of Ophthalmology, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Chung-May Yang, MD National Taiwan University Hospital
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Responsible Party: Chung-May Yang/Department of Opthalmology, National Taiwan University Hospital, Department of Opthalmology, National Taiwan University Hospital Identifier: NCT00656435    
Other Study ID Numbers: 200709051M
First Posted: April 11, 2008    Key Record Dates
Last Update Posted: April 11, 2008
Last Verified: February 2008
Keywords provided by National Taiwan University Hospital:
proliferative diabetic retinopathy
bevacizumab (Avastin)
vitreous hemorrhage
long acting gas
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors