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

Phase

Condition

N/A

Treatment

Tenecteplase (until trial protocol V04: Alteplase)

Alteplase

Clinical Study ID

NCT04965038

2021-000183-29

Ages > 18
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Acute non-arteritic CRAO (i.e. sudden, painless monocular vision loss) ≤ 12 hoursafter symptom onset confirmed by an experienced ophthalmologist through assessmentof: BCVA, intraocular pressure, swinging flash light test (relative afferent pupildefect), 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 WHOICD-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

Exclusion Criteria:

Suspected giant cell arteritis
Other-than-CRAO cause of acute visual loss (e.g., retinal detachment, vitreoushemorrhage, 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

Study Design

Tenecteplase (until trial protocol V04: Alteplase)

October 10, 2022

December 31, 2026

Study Description

Non-arteritic, thromboembolic central retinal artery occlusion (CRAO) is an acute neurovascular-ophthalmological emergency which leads to severe and permanent vision loss in the affected eye in ~ 95% of cases. Despite a variety of widely practiced "conservative standard treatments", such as hemodilution, ocular massage, and paracentesis, there is no evidence-based therapy for non-arteritic CRAO. Animal models have proven a limited ischemic tolerance of the retina with irreversible damage occurring within only four hours after disruption of blood flow. This is why rapid reperfusion represents THE logical therapeutic approach. Two recent meta-analyses indicate early intravenous thrombolysis to be beneficial in CRAO. Therefore, the REVISION trial will investigate intravenous alteplase in CRAO as it is practiced in acute ischemic stroke, i.e. within 4.5 hours after symptom onset.

Sequential evaluation by optical coherence tomography (OCT) will visualize dynamic ischemic changes of the retina during and after CRAO. The REVISION observational study will enroll patients within 12 hours of symptom onset and aims at comparing late time window retinal findings to early ischemic changes found in patients of the randomized REVISION interventional trial. Ultimately, OCT may become the preferred tool when it comes to assess retinal tissue viability in patients with an unknown CRAO onset (e.g. wake-up CRAO), and CRAO patients who present in an extended time window beyond 4.5 hours.

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.

Connect with a study center

University Hospital Tuebingen
Tuebingen, 72076
Germany
Active - Recruiting

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