TENecteplase in Central Retinal Artery Occlusion Stuy (TenCRAOS)

Inclusion Criteria:

1. Non-arteritic central retinal artery occlusion with ≥ 1.0 logMAR visual acuitiy andsymptoms lasting less than 4.5 hours.

2. Ability to administer the Investigator Medicinal Product (IMP) within 4.5 hours ofsymptom 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, shecannot be pregnant, OR if there is a possibility that she is pregnant, a negativepregnancy 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, combinedarterial-venous occlusion, proliferative diabetic retinopathy, elevated intraocularpressure (> 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 (bloodpressure >185/110 mmHg), despite medical therapy, or clinical suspicion of acutesystemic inflammation.

4. Presence of intracranial haemorrhage on brain MRI/CT.

5. Medical history: heart attack within the last 6 weeks, intracerebral bleeding orneurosurgical operation within the last 4 weeks, therapy with anticoagulation,allergic reaction to contrast agent, hemorrhagic diathesis, aneurysms, inflammatoryvascular 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-upexaminations.

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 thelast 48 hours.

13. Any history of central nervous system damage (ie, neoplasm, aneurysm, intracranialor 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, portalhypertension (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 3months.

27. Dementia.