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TENecteplase in Central Retinal Artery Occlusion Stuy (TenCRAOS)

PHASE3RECRUITING

TENecteplase in Central Retinal Artery Occlusion (TenCRAOS): A Prospective, randomized-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 randomization).

A Prospective, randomized-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 randomization).

At all participating centers, ophthalmologists are involved in the diagnosis and visual outcome measurements using a standardized protocol. The patients will be promptly examined by the ophthalmologist. As soon as the CRAO is diagnosed by the ophthalmologist, the patients will be managed in the stroke unit during treatment, monitoring, and medical investigations.

After treatment in the stroke unit, the patients will be re-examined by an ophthalmologist and a neurologist as an out-patient at (30 ±5) and 90 (±15) days.

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Study details:

Central retinal artery occlusion (CRAO) is an ophthalmologic emergency that, without prompt revascularization, bears high risk of permanent blindness. The condition is typically the result of an artery-to-artery embolism from a carotid plaque or cardio embolism. A recent meta-analysis of observational data indicates that prompt revascularization with systemic thrombolysis might improve outcome.

A randomized controlled trial of early systemic thrombolysis for CRAO is therefore warranted. The aim of this project is to assess the effect of systemic tissue plasminogen activator tenecteplase versus placebo administered within 4. 5 hours of CRAO onset in patients admitted to the participating hospitals in Europe.

The main endpoint is the proportion of patients with ≤ 0. 7 logMAR visual acuity 30 (±5) days after treatment, representing an improvement in visual acuity of at least 0. 3 logMAR, equal to at least 15 letters/three lines on a visual acuity chart.

In addition, we will access differences in visual field parameters and patient reported outcome measures between the groups. This study is based on a broad collaboration and interaction between leading ophthalmologists and neurologists in European centres.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Ability to administer the Investigator Medicinal Product (IMP) within 4.5 hours of symptom onset.

Age ≥18 years.

Informed written consent of the patient.

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

No other active intervention targeting CRAO.

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).

Systemic diseases; severe general diseases, systemic arterial hypertension (blood pressure >185/110 mmHg), despite medical therapy, or clinical suspicion of acute systemic inflammation.

Presence of intracranial haemorrhage on brain MRI/CT.

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.

No willingness and ability of the patient to participate in all follow-up examinations.

Pregnancy (if suspicion of pregnancy s-hCG or u-hCG must be negative).

Allergy or intolerance to any ingredients of IMP or placebo or gentamicin.

Other conditions / circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, no fixed abode).

Significant bleeding disorder either at present or within the past 6 months.

Effective oral anticoagulant treatment, eg, warfarin sodium (INR >1.3).

Effective anticoagulant treatment with heparin or low molecular weight heparin the last 48 hours.

Any history of central nervous system damage (ie, neoplasm, aneurysm, intracranial or spinal surgery).

Known hemorrhagic diathesis.

Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with acute myocardial infarction).

Recent non-compressible vessel puncture within 2 weeks.

Recent trauma to the head or cranium.

Prolonged cardiopulmonary resuscitation (>2 minutes) within the past 2 weeks.

Acute pericarditis and/or subacute bacterial endocarditis.

Acute pancreatitis.

Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis.

Active peptic ulceration.

Arterial aneurysm and known arterial/venous malformation.

Neoplasm with increased bleeding risk.

Any known history of hemorrhagic stroke or stroke of unknown origin.

Known history of ischemic stroke or transient ischemic attack in the preceding 3 months.

Dementia.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2020-10-30

Primary completion: 2024-10-28

Study completion finish: 2025-01-31

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT04526951

Intervention or treatment

DRUG: Intravenous injection of Tenecteplase and one dose of placebo tablet

DRUG: One tablet of Acetylsalicylic Acid and one dose of IV placebo

Conditions

• Central Retinal Artery Occlusion

Image related to Central Retinal Artery Occlusion

Condition: Central Retinal Artery Occlusion
DRUG: Intravenous injection of Tenecteplase and one dose of placebo tablet and other drugs
Melbourne, Not Specified, Australia
Sponsor: Oslo University Hospital

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

St Vincent's Hospital Melbourne

Research sites nearby

Select from list below to view details:

St Vincent's Hospital Melbourne
Melbourne, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Tenecteplase The total dose of tenecteplase is 0.25 mg/kg body weight, maximum 25 mg. The total dose will be given as an intravenous bolus	DRUG: Intravenous injection of Tenecteplase and one dose of placebo tablet Drug: Tenecteplase Tenecteplase administered as an intravenous injection (0.25 mg/kg body weigh; maximum 25 mg)
ACTIVE_COMPARATOR: acetylsalicylic acid one tablet of aspirin 300 mg Other Name: Aspirin	DRUG: One tablet of Acetylsalicylic Acid and one dose of IV placebo 300 mg Acetylsalisylic acid

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Proportion of patients with ≤ 0.7 logMAR visual acuity in the affected eye at 30 (±5) days after treatment, representing an improvement in visual acuity of at least 0.3 logMAR (intention-to-treat (ITT) analysis).	logMAR	30 (±5) days

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Proportion of patients with ≤ 0.5 logMAR visual acuity in the affected eye at 30 (±5) and 90 (±15) days.	logMAR	30 (±5) and 90 (±15) days
Mean improvement in logMAR visual acuity in the affected eye from baseline to 30 (±5) and 90 (±15) days.	logMAR	30 (±5) and 90 (±15) days
Proportion of patients with visual recovery (logMAR ≤ 0.7) and (logMAR ≤ 0.5) in the affected eye 30 (±5) and 90 (±15) days in patients who were treated with tenecteplase within 3 hours of onset	logMAR	30 (±5) and 90 (±15) days
Number of test points seen (of 100) on monocular Esterman perimetry at 30 (±5) and 90 (±15) days	Number of test points	30 (±5) and 90 (±15) days
Acute ischemic lesions on follow-up on diffusion-weighted (DWI) MRI or on brain CT at baseline and 24hrs.	DWI lesions	24 hours
National Institutes of Health Stroke Scale score (NIHSS) at 24hrs and discharge.	NIHSS score	24 hours
Modified Rankin Scale score (mRS) at discharge, 30 (±5) and 90 days (±15) days.	mRS score	Discharge, 30 (±5) and 90 days (±15) days.
Mean score on National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) at 30 (±5) and 90 (±15) days	Visual function related quality of life at 30 and 90 days. Measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases. 100 = best possible, 0 = worst possible	30 (±5) and 90 (±15) days
Mean score on EQ-5D at 30 (±5) and 90 (±15) days	Quality of life reported at 30 and 90 days. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	30 (±5) and 90 (±15) days
Presence of ocular neovascularisation at 30 (±5) and 90 (±15) days	presence	30 (±5) and 90 (±15) days

Frequently Asked Questions

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References

Clinical Trials Gov: TENecteplase in Central Retinal Artery Occlusion Stuy (TenCRAOS)