TENECTEPLASE IN CENTRAL RETINAL ARTERY OCCLUSION STUDY (TenCRAOS): A Prospective, randomised-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomisation)

Phase 3

Recruiting

• Conditions: Central retinal artery occlusion

• Registration Number: 2024-517606-29-00
• Lead Sponsor: Oslo University Hospital HF

Brief Summary

To assess the effect of systemic tenecteplase within 4.5 hours of onset of CRAO.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-31
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: Authorised, recruiting
• Sex: Not specified
• Target Recruitment: 76

Inclusion Criteria

1. Non-arteritic central retinal artery occlusion with ≥ 1.0 logMAR best-corrected visual acuity 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. Non-arteritic central retinal artery occlusion with ≥ 1.0 logMAR best-corrected visual acuity 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. 1. No 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 (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 (2)), 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 (including placebo) or gentamicin or acetylsalicylic acid. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint: Proportion of patients with ≤ 0.7 logMAR best-corrected visual acuity in the affected eye at 30 (±5) days after treatment, representing an improvement in best-corrected visual acuity of at least 0.3 logMAR (intention-to-treat (ITT) analysis).		Primary endpoint: Proportion of patients with ≤ 0.7 logMAR best-corrected visual acuity in the affected eye at 30 (±5) days after treatment, representing an improvement in best-corrected visual acuity of at least 0.3 logMAR (intention-to-treat (ITT) analysis).

Trial Locations

Locations (18)

UZ Leuven; 🇧🇪 Leuven, Belgium

Aarhus Universitet; 🇩🇰 Aarhus N, Denmark

Rigshospitalet; 🇩🇰 Copenhagen Oe, Denmark

Copenhagen University Hospital; 🇩🇰 Copenhagen Nv, Denmark

HUS-Yhtymae; 🇫🇮 Helsinki, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

Mater Misericordiae University Hospital; 🇮🇪 Dublin 7, Ireland

Region Vaesternorrland; 🇸🇪 Sundsvall, Sweden

Karolinska Institutet; 🇸🇪 Solna, Sweden

Sykehuset Telemark HF; 🇳🇴 Skien, Norway

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UZ Leuven

🇧🇪Leuven, Belgium

Robin Lemmens

Site contact

003216347294

robin.lemmens@uzleuven.be