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Sponsored by: |
National Taiwan University Hospital |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00656435 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | Bevacizumab Pretreatment and Long Acting Gas Infusion on the Vitreous Clear-up After Diabetic Vitrectomy |
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 |
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A: Experimental
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy
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Drug: Bevacizumab
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy
|
B: No Intervention
Patients will not receive bevacizumab pretreatment
|
Ages Eligible for Study: | 20 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Taiwan | |
Department of Ophthalmology, National Taiwan University Hospital | |
Taipei, Taiwan, 100 |
Principal Investigator: | Chung-May Yang, MD | National Taiwan University Hospital |
Responsible Party: | Department of Opthalmology, National Taiwan University Hospital ( Chung-May Yang/Department of Opthalmology, National Taiwan University Hospital ) |
Study ID Numbers: | 200709051M |
Study First Received: | March 30, 2008 |
Last Updated: | April 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00656435 |
Health Authority: | Taiwan: Department of Health |
proliferative diabetic retinopathy bevacizumab (Avastin) vitreous hemorrhage long acting gas |
Diabetic Retinopathy Eye Diseases Diabetes Mellitus Vascular Diseases Endocrine System Diseases Bevacizumab |
Endocrinopathy Hemorrhage Vitreous Hemorrhage Diabetes Complications Retinal Diseases Diabetic Angiopathies |
Antineoplastic Agents Therapeutic Uses Growth Substances Physiological Effects of Drugs Cardiovascular Diseases |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |