TENECTEPLASE IN CENTRAL RETINAL ARTERY OCCLUSION STUDY(TenCRAOS): A RANDOMIZED CONTROLLED TRIAL OF ACUTE CLOTSOLVING MEDICATION IN CENTRAL RETINALY ARTERY OCCLUSION.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 78

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

1.Branch retinal artery occlusion, cilioretinal artery supplying the macula, combined arterial-venous occlusion, proliferative diabetic retinopathy, or elevated intraocular pressure (> 30 mmHg).
2.Systemic diseases; severe general diseases, systemic arterial hypertension (blood pressure >185/110 mmHg), despite medical therapy, or clinical suspicion of acute systemic inflammation.
3.Presence of intracranial haemorrhage on brain MRI/CT.
4.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, haemorrhagic diathesis, aneurysms, inflammatory vascular diseases (eg, giant cell arteritis, granulomatosis with polyangitis), endocarditis, or gastric ulcer.
5.No willingness and ability of the patient to participate in all follow-up examinations.
6.Pregnancy (if suspicion of pregnancy s-hCG or u-hCG must be negative).
7.Allergy or intolerance to any ingredients of IMP or placebo or gentamicin.
8.Other conditions / circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, no fixed abode).
9.Significant bleeding disorder either at present or within the past 6 months.
10.Effective oral anticoagulant treatment, eg, warfarin sodium (INR >1.3).
11.Effective anticoagulant treatment with heparin or low molecular weight heparin the last 48 hours.

12.Any history of central nervous system damage (ie, neoplasm, aneurysm, intracranial or spinal surgery).
13.Known hemorrhagic diathesis.
14.Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with acute myocardial infarction).
15.Recent non-compressible vessel puncture within 2 weeks.
16.Recent trauma to the head or cranium.
17.Prolonged cardiopulmonary resuscitation (>2 minutes) within the past 2 weeks.
18.Acute pericarditis and/or subacute bacterial endocarditis.
19.Acute pancreatitis.
20.Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis.
21.Active peptic ulceration.
22.Arterial aneurysm and known arterial/venous malformation.
23.Neoplasm with increased bleeding risk.
24.Any known history of hemorrhagic stroke or stroke of unknown origin.
25.Known history of ischemic stroke or transient ischemic attack in the preceding 3 months.
26.Dementia.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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