Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone (VITARM)
2013年10月14日 更新者:Attila Vajas
Randomized, Double Blinded, Controlled, Two-center Study Assessing the Safety and Efficacy of Intravitreal Ranibizumab as a Preoperative Adjunct Treatment Before Vitrectomy Surgery in Proliferative Diabetic Retinopathy (PDR) Compared to Vitrectomy Alone
This study investigates the hypothesis that ranibizumab injection given into the eye is a safe, efficacious and helping treatment option applied before surgical intervention of the proliferative diabetic retinal eye disorder.
研究概览
地位
未知
条件
详细说明
This is a randomized, double blinded , controlled, two-center study assessing the feasibility, efficacy and safety of intravitreal ranibizumab injection applied as a preoperative adjunct treatment before vitrectomy surgery in severe proliferative diabetic retinopathy (PDR).
Comparator arm consists of patients receiving standard vitrectomy alone with sham intravitreal injection preoperatively.
研究类型
介入性
注册 (预期的)
70
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Debrecen、匈牙利、H-4012
- University of Debrecen, Medical and Health Science Center, Faculty of Medicine, Department of Ophthalmology
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- male or female 18 or older who have signed an informed consent
- Type I or II diabetes mellitus and severe proliferative retinopathy with tractional retinal detachment, tractional-rhegmatogenous retinal detachment, tractional detachment complicated with vitreous haemorrhage or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation
- study eye BCVA must have at least light perception and must not exceed 70 letters using ETDRS at testing distance 4 meters
- study eye vision decrease must be resulted from severe PDR
Exclusion Criteria:
- Active ocular inflammation or infection
- History of uveitis
- Uncontrolled glaucoma
- High myopia
- Any concurrent intraocular condition in the study eye that in the opinion of the investigator could confound the study results
- Former treatment with anti-angiogenic drugs within 30 days preceding Day 1 in the study eye
- History of vitrectomy within 60 days preceding Day 1 in the study eye
- History of intraocular surgery within 30 days preceding Day 1 in the study eye
- Untreated diabetes mellitus
- Severe hypertension (systolic pressure higher than 160mmHg)
- Current use of systemic medications known to be toxic to the retina
- History of thromboembolic events (incl MI and stroke) within 5 years
- Major surgery within previous 3 months or planned within the next 28 days
- Known coagulation abnormalities or current use of anticoagulative medications other than aspirins
- Known hypersensitivity to ranibizumab or any component of it
- Women of childbearing potential unless 2 methods of birth control applied
- Pregnant or lactating women
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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:vitrectomy with ranibizumab
Patients receiving adjunct preoperative intravitreal ranibizumab (3±1 days) before vitrectomy surgery
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ranibizumab 10mg/ml intravitreal injection, 0,05 ml
其他名称:
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安慰剂比较:vitrectomy without ranibizumab
Patients receiving sham treatment before vitrectomy as a comparator arm
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sham intravitreal injection before vitrectomy surgery
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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 |
---|---|---|
Efficacy of preoperative intravitreal ranibizumab
大体时间:OP day
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Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy
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OP day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in BCVA.
大体时间:6 months
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6 months
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Effect in anatomical changes.
大体时间:3 ±1 days after injection
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3 ±1 days after injection
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Safety.
大体时间:Over 6 months.
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Over 6 months.
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Retinal circulation integrity.
大体时间:Month 1, 3, 6.
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Evaluating the circulation of original retinal vessels, evaluating the size of proliferative vessels (size of leaking areas and number of leaking points measured by Fluorescein angiography )
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Month 1, 3, 6.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员:Attila Vajas, MD、National Institute of Pharmacy
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年3月1日
初级完成 (实际的)
2013年9月1日
研究完成 (预期的)
2013年12月1日
研究注册日期
首次提交
2009年7月1日
首先提交符合 QC 标准的
2009年7月1日
首次发布 (估计)
2009年7月2日
研究记录更新
最后更新发布 (估计)
2013年10月16日
上次提交的符合 QC 标准的更新
2013年10月14日
最后验证
2013年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
ranibizumab and vitrectomy的临床试验
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USDA Grand Forks Human Nutrition Research CenterCalifornia Polytechnic State University-San Luis Obispo完全的
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Sykehuset Asker og BaerumUllevaal University Hospital完全的
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University of British ColumbiaSocial Sciences and Humanities Research Council of Canada完全的
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Dana-Farber Cancer Institute邀请报名