Bevacizumab and Long Acting Gas in Diabetic Vitrectomy

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00656435
First received: March 30, 2008
Last updated: April 7, 2008
Last verified: February 2008
  Purpose

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 Intervention Phase
Proliferative Diabetic Retinopathy
Drug: Bevacizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bevacizumab Pretreatment and Long Acting Gas Infusion on the Vitreous Clear-up After Diabetic Vitrectomy

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The severity of intraoperative bleeding and vitreous clear-up time. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of prolonged vitreous clear-up (≥ 3 weeks) and recurrent hemorrhage rate. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: December 2006
Study Completion Date: February 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656435

Locations
Taiwan
Department of Ophthalmology, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chung-May Yang, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Chung-May Yang/Department of Opthalmology, National Taiwan University Hospital, Department of Opthalmology, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00656435     History of Changes
Other Study ID Numbers: 200709051M
Study First Received: March 30, 2008
Last Updated: April 7, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
proliferative diabetic retinopathy
bevacizumab (Avastin)
vitreous hemorrhage
long acting gas

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014