EUCTR2021-000183-29-DE进行中（未招募）1 期
Early Reperfusion Therapy with Intravenous Alteplase for Recovery of VISION in Acute Central Retinal Artery Occlusion (REVISION) - A double-blind randomized placebo-controlled phase III proof-of-concept trial
Eberhard-Karls University Tübingen, Med. Fac. rep. by University Hospital and its Commercial Director0 个研究点目标入组 1,400 人开始时间: 2021年7月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •?Age = 18 years
- •?Acute non-arteritic CRAO (i.e. sudden, painless monocular vision loss) = 12 hours after symptom onset confirmed by an experienced ophthalmologist through assessment of: BCVA, intraocular pressure, swinging flash light test (relative afferent pupil defect), slit-lamp biomicroscopy, fundoscopy, and OCT of the macula of both eyes* (*within the 4.5-hour time window: to be skipped if not feasible = 10 minutes; beyond the 4.5-hour time window: mandatory)
- •?BCVA of LogMAR = 1.3 in the affected eye (functional blindness according to WHO ICD-11)
- •?Reading must have been possible with the affected eye before CRAO (LogMAR = 0.5)
- •?Neurological examination performed by an experienced stroke neurologist
- •?Brain imaging as per local standard for acute retinal ischemia/stroke assessment, either cranial computed tomography (CT) or cranial magnetic resonance imaging (MRI)
- •Additional inclusion criteria for interventional study:
- •?Initiation of study treatment (IVT or placebo) by an experienced stroke neurologist within = 4.5 hours of certain symptom onset
- •?Written informed consent (interventional study) given by the patient
- •Additional inclusion criteria for observational study:
- •?Participation of patients within = 4.5 hours of symptom onset is only allowed in case of contraindication(s) for IVT of contraindication(s) for IVT or history of hypersensitivity to Acitlyse® or in case of pregnancy or laction
- •?Written informed consent (observational study) given by the patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •?Suspected giant cell arteritis
- •?Other-than-CRAO cause of acute visual loss (e.g., retinal detachment, vitreous hemorrhage, acute glaucoma, acute optic neuritis)
- •?Rapidly improving vision in the affected eye
- •?Acute ischemic stroke with indication for on-label intravenous thrombolysis (IVT)
- •?Any co-existing or terminal disease with anticipated life expectancy of < 3 months
- •?Prior participation in the REVISION trial
- •Additional exclusion criteria for interventional study:
- •?Pregnancy or lactation
- •?History of hypersensitivity to Actilyse®
- •?Contraindications for IVT:
- •ointracranial hemorrhage or subacute infarct on brain imaging
研究者
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