RecruitingPhase 3NCT04965038

Early Reperfusion Therapy With Intravenous Thrombolysis for Recovery of VISION in Acute Central Retinal Artery Occlusion

Sponsor

University Hospital Tuebingen

Enrollment

422 participants

Start Date

Oct 10, 2022

Study Type

INTERVENTIONAL

Conditions

central retinal artery occlusion

Summary

Non-arteritic, thromboembolic central retinal artery occlusion (CRAO) is an acute neurovascular-ophthalmological emergency which leads to severe and permanent vision loss; no evidence-based therapy does exist. Two recent meta-analyses indicate early intravenous thrombolysis to be beneficial in CRAO. Therefore, the REVISION randomized placebo-controlled interventional trial will investigate intravenous alteplase in CRAO as it is practiced in acute ischemic stroke, i.e. within 4.5 hours after symptom onset. The REVISION observational study will evaluate retinal changes on optical coherence tomography (OCT) in patients within 12 hours of CRAO onset, and the REVISION substudy, which will be conducted adjunct to either the interventional or the observational study, will evaluate the value of the retrobulbar spot sign for prediction of outcome and treatment response.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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)

Exclusion Criteria6

Suspected giant cell arteritis
Other-than-CRAO cause of acute visual loss (e.g., retinal detachment, vitreous hemorrhage, acute glaucoma, acute optic neuritis)
BCVA of LogMAR < 1.3 or 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