Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT04965038

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

Led by University Hospital Tuebingen · Updated on 2025-04-27

422

Participants Needed

1

Research Sites

220 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acute non-arteritic central retinal artery occlusion (CRAO) with sudden, painless vision loss in one eye within 12 hours of symptom onset confirmed by an ophthalmologist using several eye tests including OCT
  • Visual acuity in the affected eye of LogMAR 1.3 or worse (functional blindness)
  • Ability to read with the affected eye before CRAO (LogMAR 0.5 or better)
  • Neurological examination done by an experienced stroke neurologist
  • Brain imaging done by CT or MRI as part of acute retinal ischemia or stroke assessment
Not Eligible

You will not qualify if you...

  • Suspected giant cell arteritis
  • Acute vision loss caused by conditions other than CRAO (such as retinal detachment, vitreous hemorrhage, acute glaucoma, or optic neuritis)
  • Visual acuity better than LogMAR 1.3 or rapidly improving vision in the affected eye
  • Presence of acute ischemic stroke needing intravenous thrombolysis
  • Any co-existing or terminal illness with life expectancy less than 3 months
  • Previous participation in the REVISION trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University Hospital Tuebingen

Tübingen, Germany, 72076

Actively Recruiting

Loading map...

Research Team

S

Sven Poli

CONTACT

J

Julia Zeller

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here