Clot-Buster shows promise for eye stroke in landmark trial
NCT ID NCT04526951
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This Phase 3 trial tested whether the clot-busting drug tenecteplase could improve vision in people with a central retinal artery occlusion (eye stroke). 81 participants received either tenecteplase or aspirin within 4.5 hours of symptoms. The main goal was to see if more patients in the tenecteplase group had significant vision improvement at 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tenecteplase (a clot-busting drug)
- What this could lead to
- If it works, this could provide a proven treatment to restore vision in people who have an 'eye stroke' (blocked artery in the eye).
- What could go wrong
- This is a small, completed Phase 3 trial (81 people). The drug carries a risk of bleeding, and results may not apply to all patients or be confirmed in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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81 people
The number who actually took part.
- Started
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Oct 2020
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Non-arteritic central retinal artery occlusion with ≥ 1.0 logMAR visual acuitiy and symptoms lasting less than 4.5 hours. 2. Ability to administer the Investigator Medicinal Product (IMP) within 4.5 hours of symptom onset. 3. Age ≥18 years. 4. Informed written consent of the patient. 5. A woman of childbearing potential (WOCBP) must confirm that in her opinion, she cannot be pregnant, OR if there is a possibility that she is pregnant, a negative pregnancy test must be confirmed before any IMP is given. Exclusion Criteria: 1. Other active intervention targeting CRAO. 2. Branch retinal artery occlusion, cilioretinal artery supplying the macula, combined arterial-venous occlusion, proliferative diabetic retinopathy, elevated intraocular pressure (\> 30 mmHg) or clinical suspicion of ophthalmic artery occlusion occlusion (e.g. choroidal nonperfusion, absence of cherry red spot, no light perception). 3. Systemic diseases; severe general diseases, systemic arterial hypertension (blood pressure \>185/110 mmHg), despite medical therapy, or clinical suspicion of acute systemic inflammation. 4. Presence of intracranial haemorrhage on brain MRI/CT. 5. Medical history: heart attack within the last 6 weeks, intracerebral bleeding or neurosurgical operation within the last 4 weeks, therapy with anticoagulation, allergic reaction to contrast agent, hemorrhagic diathesis, aneurysms, inflammatory vascular diseases (eg, giant cell arteritis, granulomatosis with polyangitis), endocarditis, or gastric ulcer. 6. No willingness and ability of the patient to participate in all follow-up examinations. 7. Pregnancy (if suspicion of pregnancy s-hCG or u-hCG must be negative). 8. Allergy or intolerance to any ingredients of IMP or placebo or gentamicin. 9. Other conditions / circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, no fixed abode). 10. Significant bleeding disorder either at present or within the past 6 months. 11. Effective oral anticoagulant treatment, eg, warfarin sodium (INR \>1.3). 12. Effective anticoagulant treatment with heparin or low molecular weight heparin the last 48 hours. 13. Any history of central nervous system damage (ie, neoplasm, aneurysm, intracranial or spinal surgery). 14. Known hemorrhagic diathesis. 15. Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with acute myocardial infarction). 16. Recent non-compressible vessel puncture within 2 weeks. 17. Recent trauma to the head or cranium. 18. Prolonged cardiopulmonary resuscitation (\>2 minutes) within the past 2 weeks. 19. Acute pericarditis and/or subacute bacterial endocarditis. 20. Acute pancreatitis. 21. Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis. 22. Active peptic ulceration. 23. Arterial aneurysm and known arterial/venous malformation. 24. Neoplasm with increased bleeding risk. 25. Any known history of hemorrhagic stroke or stroke of unknown origin. 26. Known history of ischemic stroke or transient ischemic attack in the preceding 3 months. 27. Dementia.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aarhus University Hospital
Aarhus, Denmark
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Bispebjerg University Hospital
Copenhagen, Denmark
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Haukeland University Hospital
Bergen, Norway
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Helse Nord Trøndelag Trust
Namsos, Norway
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Helsinki University Hospital
Helsinki, Finland
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Karolinska University Hospital
Stockholm, Sweden
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Kauno Klinikos Kaunas
Kaunas, Lithuania
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Oslo University Hospital
Oslo, 0424, Norway
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Rigshospitalet University Hospital
Copenhagen, Denmark
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St Olav University Hospital
Trondheim, Norway
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Telemark Hospital Trust
Skien, Norway
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Turku University Hospital
Turku, Finland
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University Hospital Antwerp
Antwerp, Belgium
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University Hospital Leuven
Leuven, 3000, Belgium
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Vestfold Hospital Trust
Tønsberg, Norway
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Vestre Viken Hospital Trust Drammen
Drammen, Norway
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Vilnius University Hospital
Vilnius, Lithuania
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Østfold Hospital Trust Kalnes, Dept of Ophthalmology
Grålum, Norway
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