CTIS2023-507388-21-00招募中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 - REVISIO
niversitaetsklinikum Tuebingen AöR0 个研究点目标入组 1,422 人开始时间: 2023年8月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,422
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 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)
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
研究者
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