Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy
Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy
研究概览
地位
详细说明
Early postoperative hemorrhage in proliferative diabetic retinopathy (PDR) patients is a major complication. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) has reported to reduce vitreous hemorrhage. Recently, numerous reports have shown the efficacy of reducing neovascularization activity before vitrectomy by preoperative intravitreal injection of anti-VEGF agents. When intravitreal bevacizumab (IVB) injection is used as an adjunct therapy, a shortterm effect is needed. Because it is reported some adverse events caused by bevacizumab injection. Hattori et al reported intravitreal injection of 0.16 mg/0.05 ml bevacizumab in PDR patients marked blockage of intravitreal VEGF concentrations in the pilot study. The purpose of this study is to evaluate low dose of intravitreal bevacizumab as a preoperative adjunct therapy reduce the postoperative vitreous hemorrhage. This study involves PDR patients who underwent vitrectomy between May 2012 and August 2013 at Surugadai Hospital of Nihon University. The risks to participants are accompanied by the intravitreal injection of bevacizumab (especially the possibility of endophthalmitis and thromboembolic events).
Between June 2012 and August 2013, one investigator (AM) randomized PDR patients with an indication for primary 25-gauge vitrectomy into a sham group and an IVB group. One day after injection, three surgeons except AM conducted the surgeries. Vitreous samples were collected at the start of surgery, and intraoperative and postoperative complications were evaluated.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Tokyo、日本、101-8309
- Surugadai Nihon university hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)
- Indicated for vitrectomy
Exclusion Criteria:
- History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Bevacizumab injection and vitrectomy
0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.
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0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
其他名称:
vitrectomy of 25 gauge system.
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假比较器:Sham injection and vitrectomy
Sham injection one day before vitrectomy.
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vitrectomy of 25 gauge system.
Sham injection one day before vitrectomy
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reoperation
大体时间:1 month
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Vitreoretinal reoperation due to recurrent vitreous hemorrhage.
|
1 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Intra Operative Hemorrhage
大体时间:End of the surgery.
|
Calculate the number of coagulators for the intra operative hemorrhage.
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End of the surgery.
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Postoperative Vitreous Hemorrhage.
大体时间:1 month
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Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.
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1 month
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Vascular Endothelial Growth Factor Concentration in Vitreous
大体时间:Start of surgery.
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Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.
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Start of surgery.
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Endolaser Photocoagulation
大体时间:End of surgery.
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Number of intraoperative endolaser photocoagulation.
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End of surgery.
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Iatrogenic Retinal Tears
大体时间:End of surgery.
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The number of participants who had intraoperative iatrogenic retinal tears.
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End of surgery.
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Surgical Time
大体时间:End of surgery.
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End of surgery.
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Postoperative Best Corrected Visual Acuity
大体时间:1 mouth after surgery.
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Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis. The minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome. |
1 mouth after surgery.
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Best Corrected Visual Acuity Change
大体时间:1 month
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Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity. The higher values represent a worse outcome. |
1 month
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Postoperative Neovascular Glaucoma
大体时间:Within 1 month after the surgery.
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The number of participants with progressive or persistent neovascular glaucoma after surgery.
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Within 1 month after the surgery.
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Elevated Intraocular Pressure
大体时间:Within 1 month after the surgery.
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The number of participants with elevated intraocular pressure after surgery.
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Within 1 month after the surgery.
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Gas Tamponade
大体时间:End of surgery.
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The number of participants with gas tamponade at the end of the surgery.
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End of surgery.
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Silicon Oil Tamponade
大体时间:End of surgery.
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The number of participants with silicon oil tamponade at the end of the surgery.
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End of surgery.
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合作者和调查者
调查人员
- 学习椅:Ayumu Manabe
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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