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临床试验/NCT00656435
NCT00656435已完成3 期

Bevacizumab Pretreatment and Long Acting Gas Infusion on the Vitreous Clear-up After Diabetic Vitrectomy

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
16
试验地点
1
主要终点
The severity of intraoperative bleeding and vitreous clear-up time.

研究概览

简要总结

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.

详细描述

From December 2006 to August 2007, consecutive patients undergoing primary pars plana vitrectomy for active proliferative diabetic retinopathy were recruited for the prospective study. Included cases should have active fibrovascular proliferation with vitreo-retinal adhesions in 3 or more sites but not extending beyond equator in more than one quadrant. Active fibrovascular proliferation is defined as visible new vessels within the proliferative membranes with any degree of fresh vitreous or preretinal hemorrhage. Exclusion criteria are: 1. History of preoperative or postoperative anticoagulant therapy; 2. History of blood diseases associated with abnormal coagulation; 3. Severe proliferation with anticipation of silicone oil usage. Informed consent is obtained in every patient before surgery. The protocol was approved by the review board and research ethics committee of National Taiwan University Hospital.

All cases in the study group are prospectively enrolled (group 1). Consecutive patients fulfilling the enrollment criteria receive intravitreal bevacizumab (1.25mg in 0.05ml) injection 7 to 9 days before surgery and intravitreal 10% C3F8 infusion at the end of surgery. The surgical outcomes are compared with a non-concurrent control group that received gas infusion only (group2). The control group is matched by baseline characteristics and the severity of diabetic proliferation with the study group. The comparisons between the two groups are possible because all the relevant parameters have been carefully documented in the control group. A single surgeon (CMY) performed all of the operations.

Operative Technique For intravitreal bevacizumab injection, after topical anesthesia, patients were disinfected three times with povidone-iodine solution and draped. After eyelid speculum put in place, the eyes are further anesthetized with proparacaine -soaked cotton-tip applicators. Bevacizumab (1.25mg in 0.05ml) is drawn into a 1 ml syringe through a 27-gauged needle from a newly opened vial and injected through a 30-gauged needle into the vitreous cavity via temporal lower pars plana. Anterior chamber paracentesis is not performed.

Standard 3-port pars plana vitrectomy as described previously is done in every case. In short, vitreoretinal traction, fibrovascular tissues, and opacified vitreous as well as blood clots adherent to the peripheral vitreous skirt are removed as completely and safely as possible. Hemostasis is obtained by raising the infusion bottle, mechanical compression using a soft-tipped cannula, endodiathermy, or a combination of the above techniques. Blood clots formed during tissue dissection are removed carefully except on the bleeding sites where they were trimmed to small islands. Panretinal photocoagulation in non-laser treated eyes or supplementary laser in previously laser-treated eyes extending beyond the level of the equator is performed. Further peripheral retinal cryotherapy (10 to 12 spots in one row) is done. 10% C3F8 intravitreal infusion is done in each case before wound closure. Finally, cryotherapy of the sclerotomy sites (1 spot, each 6 seconds, for 3 sclerotomy sites) is performed.

After surgery, all patients are kept in a prone position overnight, and maintained a head-down position during waking hours. The patients are then allowed to lie on either side during sleep for 3 weeks thereafter. Ophthalmological examinations are performed in the first 4 days after surgery, then weekly for 4 weeks, biweekly for 1 month, and then monthly for at least 6 months.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Not primary pars plana vitrectomy
  • post-operative follow-up duration less than three months
  • HbA1c > 8.0

研究组 & 干预措施

A

Experimental

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy

干预措施: Bevacizumab (Drug)

结局指标

主要结局

The severity of intraoperative bleeding and vitreous clear-up time.

时间窗: Six months

次要结局

  • Percentage of prolonged vitreous clear-up (≥ 3 weeks) and recurrent hemorrhage rate.(Six months)

研究者

申办方类型
Other

研究点 (1)

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