Early Reperfusion Therapy with Intravenous Thrombolysis for Recovery of VISION in Acute Central Retinal Artery Occlusion (REVISION) - A double-blind randomized placebo-controlled phase III trial

简要总结

主要结局

次要结局

• NIHSS at V2 (continuous)
• NEI-VFQ-25 at V3 and V4 (continuous)
• mRS at V3, and V4 (dichotomized into categories 0 – 1 (excellent outcome) vs. 2 – 6, 0 – 2 (functional independence) vs. 3 – 6, and shift analysis)
• Functional recovery to LogMAR ≤ 0.5 at V3 (30 ± 5 days) (dichotomized) in the per protocol population
• Functional recovery to LogMAR ≤ 0.5 at V2 (18 – 72 hours), and V4 (90 ± 10 days) (dichotomized)
• Shift in visual outcome categories (according to WHO ICD-11 (WHO, 2019): normal vision (LogMAR ≤ 0), mild visual impairment (LogMAR > 0 and ≤ 0.5), moderate visual impairment (LogMAR > 0.5 and ≤ 1.0), severe visual impairment (LogMAR > 1.0 and ≤ 1.3), counting fingers (LogMAR > 1.3 and ≤ counting fingers), hand motion or light perception, and no light perception) at V2, V3, and V4
• Dichotomized analysis of visual outcome: ‘normal vision to moderate visual impairment’ vs. ‘severe visual impairment or functional blindness’ and ‘normal vision to severe visual impairment’ vs. ‘functional blindness’ at V2, V3, and V4
• Kinetic visual field using III4e mark at V3 and V4 (as a continuous variable)
• Central retinal artery recanalization assessed using OCTA of the optic nerve head and the macula at V2, V3, and V4 (continuous)
• Retinal arterial perfusion assessed using fluorescein angiography at V3 and V4 (continuous)
• Fraction of patients with, number, and volume of acute ischemic lesions on follow-up diffusionweighted (DWI) cranial magnetic resonance imaging (MRI) at V2 (dichotomous and continuous, respectively)
• Any bleeding until V2 by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 classification of adverse events (AE), i.e., mild, moderate, severe, life-threatening, leading to death.