Bevacizumab and Long Acting Gas in Diabetic Vitrectomy
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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 |
- The severity of intraoperative bleeding and vitreous clear-up time. [ Time Frame: Six months ] [ Designated as safety issue: No ]
- 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 |
Inclusion Criteria:
- anticoagulant therapy has not been used prior to surgery or during post-operative follow-up period.
- no medical history of blood diseases associated with abnormal blood coagulation is present.
- Having active fibrovascular proliferation with vitreo-retinal adhesions in 3 or more sites but not extending beyond the equator in more than one quadrant.
- Severe retinopathy with anticipation of silicone oil usag
- Age is between 20 to 85 years old.
Exclusion Criteria:
- Not primary pars plana vitrectomy
- post-operative follow-up duration less than three months
- Pregnancy
- HbA1c > 8.0
Contacts and Locations| Taiwan | |
| Department of Ophthalmology, National Taiwan University Hospital | |
| Taipei, Taiwan, 100 | |
| 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 May 21, 2013