[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608798":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":10,"locations":27,"responsibleParty":50,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":30,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Anterior ischemic optic neuropathy (AION)",null,"Adults aged 50 years or more with new onset AION, here defined as ipsilateral papilledema, visual impairment (affecting BCVA and\u002For visual field) and relative afferent pupillary defect (RAPD).",[13],"Diagnostic Test: Positron Emission Tomography \u002F Magnetic Resonance Imaging",{"label":15,"type":10,"description":16,"interventionNames":17},"Giant cell arteritis (GCA) without GCA-related vision loss","Adults aged 50 years or more, newly diagnosed with GCA (clinically and ultrasound-confirmed), and without permanent or transient loss of vision or double vision.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","Positron Emission Tomography \u002F Magnetic Resonance Imaging","FDG PET\u002FMRI with Black Blood sequences of the head and neck area.",[9,15],[25,26],"Optical Coherence Tomography","Temporal Artery Ultrasound",[28],{"facility":29,"status":30,"city":31,"state":10,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Rigshospitalet - Glostrup","RECRUITING","Glostrup Municipality","2600","Denmark","DK",{"type":36,"coordinates":37},"Point",[38,39],12.40377,55.6666,{"lat":39,"lon":38},[42,47],{"name":43,"role":44,"phone":45,"phoneExt":10,"email":46},"Andreas W Bendtsen, MD","CONTACT","+4538634446","andreas.worm.bendtsen@regionh.dk",{"name":48,"role":49,"phone":10,"phoneExt":10,"email":10},"Andreas Worm W Bendtsen, MD","PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Steffen Hamann","Clinical Professor","100608798","orbital-vascular-inflammation-in-ischemic-optic-neuropathy-and-giant-cell-arteritis-100608798",false,"NCT07206238","Orbital Vascular Inflammation in Ischemic Optic Neuropathy and Giant Cell Arteritis","VISION-GCA","Inclusion Criteria:\n\nFor AION group:\n\n* 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\u002For visual field; Relative afferent pupillary defect (RAPD), except if mydriatic agents have been administered or if bilateral optic neuropathy is present.\n* Age ≥ 50 years\n\nFor GCA group:\n\n* Clinically- and ultrasound-confirmed, newly diagnosed GCA\n* 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\n* Age ≥ 50 years\n\nExclusion Criteria:\n\n* Ferromagnetic implants\n* Severe renal impairment with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²\n* Allergy to MRI contrast agents\n* Severe claustrophobia\n* Pregnancy or breastfeeding\n* Previously documented ipsilateral optic neuropathy or giant cell arteritis\n* More than 5 days of treatment with prednisolone prior to inclusion","ALL","50 Years",{"count":63,"type":64},122,"ESTIMATED","OBSERVATIONAL","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.\n\nIn this project, the investigators will use FDG PET\u002FMRI with Black Blood (BB) sequences and OCT-imaging to study patients with GCA and\u002For ischemic optic nerve disease. The investigators will look for signs of inflammation in and around the small vessels of the orbit using PET\u002FMRI and study subtle retinal changes using OCT images.\n\nThe investigators want to answer the following research questions:\n\nDo patients with ischemic optic nerve disease and GCA show signs of inflammation in the orbital vessel wall on PET\u002FMRI-scans, that are not present in patients with NAION?\n\nDo GCA patients without vision loss, but with signs of orbital vessel wall inflammation on PET\u002FMRI-scans, have a higher risk of later vision loss than GCA patients without?\n\nCan subtle changes in the retina, detectable through OCT, help distinguish between GCA-related vision loss and NAION?\n\nThis will, to our knowledge, be the first study to systematically use FDG PET\u002FMRI BB-scans to illuminate vascular changes in the orbit of patients with GCA and\u002For ischemic optic nerve disease. The results may improve diagnosis and treatment of GCA and NAION in the future. The investigators hope that this will help prevent blindness and other serious complications in patients with GCA, while also avoiding unnecessary treatments for patients with NAION.",[68,69,70],"Giant Cell Arteritis (GCA)","Ischemic Optic Neuropathy","NAION - Non-Arteritic Ischemic Optic Neuropathy",[72,73,74,75,76],"FDG PET\u002FMRI BB","OCT","Retinal biomarkers","Giant cell arteritis","ischemic optic neuropathy","2026-05-02",{"date":79,"type":80},"2026-05-07","ACTUAL",{"date":82,"type":80},"2026-01-14",{"date":84,"type":64},"2029-03-30",{"name":5,"class":6},1]