Tenecteplase in Central Retinal Artery Occlusion
Stephen James Ryan LIS Nevrologi
Stipendiat Oslo Universitetssykehus
Ischemic stroke is defined as an «episode of neurological dysfunction caused by focal cerebral, spinal or retinal infarction»
C.R.A.O. • Stroke emergency – Time is Brain • Ophthalmologic emergency – Time Is Vision
• High risk of permanent blindness without prompt revascularization
• No evidence-based treatment option
Ophthalmologic diagnosis Bedside findings • Visual acuity: Counting fingers/light
perception • Afferent pupillary defect
Fundoscopic findings • Superficial opacification or whitening
of the retina in the posterior pole • Cherry-red spot: a bright red foveal
area • Box-carring of retinal arteries and veins • Retinal arterial attenuation • Optic disc edema
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Conclusions: This study showed that the administration of intravenous alteplase within 4.5 hours of symptom onset is associated with a higher likelihood of a favourable visual outcome for acute central retinal artery occlusion.
• Design: 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).
• Main objective: To assess the effect of IV TNK ≤ 4.5 h onset of CRAO in a large multi-site trial.
• Primary endpoint: Proportion of patients with ≤ 0.7 logMAR visual acuity 30 days after treatment, representing an improvement in visual acuity of at least 0.3 logMAR
• Sample size: 78
TenCRAOS - Overview
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Diagnostikk og behandling med studiemedisin
(injeksjon og kapsel) innen 4,5 timer
Overvåking og undersøkelser på
nevrologisk avdeling/slagenhet
1-3 dager
Kontroll hos øyelege og nevrolog etter
1 mnd
Kontroll hos øyelege og nevrolog etter
3 mnd
Where, What and When
Recruitment period:
October 2020
to January 2024
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.
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Exclusion criteria • 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.
• Loooooong list!
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Studiemedisin – Investigation Medicinal Product
Velkommen til TenCRAOS-møte!
Fredag 30. oktober kl 11.30-13 På Zoom og Rikshospitalet
Study Team Oslo: PI – Anne Hege Aamodt; CI – Stephen James Ryan; SN – Christian Kefaloykos;
SN – Ansar Quadeer
Many thanks to TEN-CRAOS Collaborators!
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Haukeland University Hospital V. Novotny, J Krohn, E. Rødahl
Stavanger University Hospital M Kurz
St. Olav University Hospital H Ellekjær, D Austeng
UNN SH Johnsen, S. Ingebrigtsen
Nordland Hospital Trust M Carlsson
Helse Nord Trøndelag Trust S Schüler
Nordmøre and Romsdal Regional Hospital ÅH Morsund
Sørlandet Hospital Trust R Solhoff
Vestfold Hospital Trust SB Krogseth
Østfold Hospital Trust B Ratajczak-Tretel
Innlandet Hospital Trust AH Farmen Vestre Viken Hospital Trust I Nakstad, Telemark Hospital Trust H Tobro OUS Morten C. Moe, Ø Jørstad, IC Olsen, KL Kraglund, D Atar, Brian Enriquez, Karolina Skagen, EC Sandset, M Skjelland, E Berge, M. Beyer and colleagues at Dep of Neurol/Ophthalmol.
Rigshospitalet UH Copenhagen TC Truelsen Aarhus University Hospital, Coordinating center in Denmark T Bek, C Ziegler Aalborg University Hospital S Due Karolinska University Hospital, Coordinating center in Sweden M Mazya Helsinki University Hospital, coordinating center in Finland D Strabian, Petra IIjas Turku UH P Ylikotila, R Roine, J Ruuskanen, University Hospital Antwerp, coordinating center in Belgium P Vanacker Mater Misericordiae University Hospital, coordinating center in Ireland S Murphy Vilnius University Hospital Santaros klinikos, coordinating centre in Lithuania Jurgita Valaikienė, MD Portugal National coordinator, Centro Hospitalar Universitário de,São João Ricardo Soares Reis
Takk for meg! Go raibh mile maith agaibh! Thank you for your attention!