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Orbital Vascular Inflammation in Ischemic Optic Neuropathy and Giant Cell Arteritis

Recruitingn/aAges 50 Years - anyAllCopenhagen University Hospital, Rigshospitalet
NCT07206238 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Giant cell arteritis (GCA) is an inflammation of the blood vessels. A dangerous complication is sudden vision loss due to insufficient blood supply to the optic nerve. However, it is often difficult to distinguish acute vision loss due to GCA from a similar condition of insufficient blood supply to the optic nerve, called NAION. Quick treatment with anti-inflammatory medication is needed in case of GCA to prevent vision loss on the eye and other serious complications. Patients with NAION have no benefit of the medication, but can have serious side effects, why it is very important to differentiate between these conditions. In this project, the investigators will use FDG PET/MRI with Black Blood (BB) sequences and OCT-imaging to study patients with GCA and/or ischemic optic nerve disease. The investigators will look for signs of inflammation in and around the small vessels of the orbit u

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📋 Eligibility rules (as published)
Inclusion Criteria: For AION group: * Clinical suspicion of newly onset ischemic optic neuropathy (A-AION or NA-AION), defined by ipsilateral findings of: Papilledema; Relevant visual impairment measured by visual acuity and/or visual field; Relative afferent pupillary defect (RAPD), except if mydriatic agents have been administered or if bilateral optic neuropathy is present. * Age ≥ 50 years For GCA group: * Clinically- and ultrasound-confirmed, newly diagnosed GCA * Absence of visual changes related to GCA in one or both eyes, including: Transient vision loss; permanent vision loss; transient double vision; permanent double vision * Age ≥ 50 years Exclusion Criteria: * Ferromagnetic implants * Severe renal impairment with eGFR \< 30 mL/min/1.73m² * Allergy to MRI contrast agents * Severe claustrophobia * Pregnancy or breastfeeding * Previously documented ipsilateral optic neuropathy or giant cell arteritis * More than 5 days of treatment with prednisolone prior to inclusion
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What it tests

  • Positron Emission Tomography / Magnetic Resonance Imaging
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Where

1 site
Rigshospitalet - Glostrup
Glostrup Municipality, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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