Early treatment for vision recovery in acute retinal artery blockage
Early Reperfusion Therapy With Intravenous Thrombolysis for Recovery of VISION in Acute Central Retinal Artery Occlusion
This study is testing if a quick treatment with a clot-busting drug can help people regain their vision after a sudden blockage in the eye's blood supply.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 422 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT04965038 on ClinicalTrials.gov |
What this trial studies
This trial investigates the use of intravenous thrombolysis with alteplase for patients suffering from acute non-arteritic central retinal artery occlusion (CRAO), a condition that can lead to severe vision loss. The study aims to administer the treatment within 4.5 hours of symptom onset, similar to protocols used in acute ischemic stroke. Additionally, it includes an observational component that evaluates retinal changes using optical coherence tomography (OCT) within 12 hours of CRAO onset. The goal is to assess the effectiveness of thrombolysis in restoring vision and to explore the predictive value of certain clinical signs for treatment response.
Who should consider this trial
Good fit: Ideal candidates are individuals with acute non-arteritic CRAO who have experienced sudden, painless vision loss within the last 12 hours.
Not a fit: Patients with suspected giant cell arteritis or those whose vision loss is due to causes other than CRAO may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision recovery for patients experiencing acute CRAO.
How similar studies have performed: Previous meta-analyses have suggested that early intravenous thrombolysis may be beneficial in CRAO, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Tübingen
- University Hospital Tuebingen — Tübingen, Germany (Recruiting)
Study contacts
- Study coordinator: Sven Poli
- Email: sven.poli@uni-tuebingen.de
- Phone: +49-7071-29-0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.