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RECRUITING
NCT04965038
PHASE3

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

Sponsor: University Hospital Tuebingen

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

422

Start Date

2022-10-10

Completion Date

2026-12-31

Last Updated

2025-04-27

Healthy Volunteers

No

Interventions

DRUG

Tenecteplase (until trial protocol V04: Alteplase)

Intravenous thrombolysis within 4.5 hours of symptom onset

Locations (1)

University Hospital Tuebingen

Tübingen, Germany