Phase Ib Study on Surgical Stabilizer Assisted Retinal Vein Cannulation (RVC) With tPA Infusion Confirmed by Intraoperative Angio-optical Coherence Tomography (Angio-OCT) for the Treatment of Central Retinal Vein Occlusion (CRVO).
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- duration of infusion
研究概览
简要总结
This phase Ib study investigates the safety and efficacy of performing a retinal vein cannulation with recombinant tissue Plasminogen Activator infusion into a retinal vein with the help of an updated dedicated surgical stabiliser for the treatment of central retinal vein occlusion.
详细描述
Investigator-initiated, unmasked, single-arm, mono-center, prospective, interventional case series phase Ib trial. In line with the previous phase I trial, this trial will be biphasic; first 3 patients will be included, when the procedure and product prove to be safe and an added value is noted from the intra-operative OCT-angiography, another 3 will be included afterwards (≥21 days between last inclusion of the first group and first inclusion of the second group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18 years
- •Recent diagnosis (<8 weeks) of CRVO
- •Recent onset of symptoms (<12 weeks)
- •Visual acuity < 5/10 in study eye
- •Visual acuity >1/10 in fellow eye
- •Central macular thickness >250µm
- •Signed informed consent prior to inclusion
排除标准
- •Fluorescein allergy
- •Active neovascularization
- •Eye disease other than CRVO or Cataract decreasing central vision
- •History of retinal surgery
- •High myopia (> -10D)
- •Contraindication for the use of systemic anticoagulant medication
- •Extensive macular ischemia noted on fluo-angiography
研究组 & 干预措施
RVC with tPA for CRVO
Single arm phase I open label study were CRVO patients will have a vitrectomy with retinal vein cannulation and a single infusion of tPA (0.25mg/ml) intravenously with a maximum dose of 1mg.
干预措施: Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg. (Procedure)
RVC with tPA for CRVO
Single arm phase I open label study were CRVO patients will have a vitrectomy with retinal vein cannulation and a single infusion of tPA (0.25mg/ml) intravenously with a maximum dose of 1mg.
干预措施: Intravenous Infusion (Drug)
结局指标
主要结局
duration of infusion
时间窗: 10 minutes
The time of infusion measured during surgery with a maximum of 10 minutes
Success rate of retinal vein cannulation
时间窗: 10 min
successful cannulation defined as peroperatively seen washout of blood in the cannulated retinal vein. The success rate is defined as the number of successful cannulations divided by the total number of cannulation attempts.
number of intervention-related non-surgical complications
时间窗: 7 days
The postoperative occurence of: * hemorrhagic cerebrovascular accidents due to rtPA (confirmed by CT-scan and neurological examination after referral to the neurologist) * large hemorrhage elsewhere to be related with the use of rtPA (as confirmed by clinical examination and/or CT-scan/ultrasound after referral to vascular surgeon)
number of intervention-related surgical complications
时间窗: 7 days
These exist of the intra-operative occurence of: * retinal vein tear (visually seen by the surgeon) * uncontrollable vitreous cavity hemorrhage (as seen by the surgeon) * retinal tear in the proximity of the cannulation site (as seen by the surgeon) * intra-/subretinal injection (as seen by the surgeon) * breakage of the needle (as seen by the surgeon) * failure of stabilizer in holding the instrument immobilized in a certain position (as seen by the surgeon)
次要结局
- intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA(7 days)
- change in retinal flow intraoperatively visualized with OCT-angiography(1 hour)
- change in visual acuity after 6 to 8 weeks(6-8 weeks)
- change in central macular thickness after 6 to 8 weeks(6-8 weeks)