Early Reperfusion Therapy for Recovery of Vision in Acute Central Retinal Artery Occlusio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1400

Inclusion Criteria

?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

Exclusion Criteria

?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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Functional recovery to best corrected visual acuity (BCVA) of Logarithm of the Minimum Angle of Resolution (LogMAR) = 0.5 (normal to mild vision impairment according to WHO ICD-11 (WHO, 2019)) in the affected eye at Visit (V) 3 (30 ± 5 days), dichotomized ITT analysis (functional recovery to LogMAR = 0.5 vs. no functional recovery, i.e., LogMAR > 0.5) ;Secondary Objective: To investigate efficacy of IVT using alternative endpoints as well as to investigate safety of IVT in non-arteritic CRAO.;Primary end point(s): Primary efficacy endpoint of the interventional study:<br>Functional recovery to best corrected visual acuity (BCVA) of Logarithm of the Minimum Angle of Resolution (LogMAR) = 0.5 (normal to mild vision impairment according to WHO ICD-11) in the affected eye at Visit (V) 3 (30 ± 5 days), intention-to-treat (ITT) analysis<br>;Timepoint(s) of evaluation of this end point: Visit 3 (30 ± 5 days)

Secondary Outcome Measures

Name	Time	Method

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