Orbital Vascular Inflammation in Ischemic Optic Neuropathy and Giant Cell Arteritis
A legfontosabb adatok
- Ki végzi
- Copenhagen University Hospital, Rigshospitalet
- Hol
- Dánia1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 122 fő, tervezett
- Kezdés
- 2026. jan. 14.
- Várható befejezés
- 2029. márc. 30.
- A vizsgálat típusa
- Megfigyeléses, 2 csoport
- A vizsgált kezelések
- Positron Emission Tomography / Magnetic Resonance Imaging
- A regiszteradat frissítve
- 2026. május 7.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for adults aged 50 or older with new sudden damage to the optic nerve from poor blood supply, or with newly diagnosed giant cell arteritis without vision problems. Everyone will have PET/MRI scans.
- Életkor
- 50 years or older
- Nem
- All sexes
- A betegség stádiuma
- One group: newly started suspected ischemic optic neuropathy (A-AION or NA-AION), with swelling of the optic disc, reduced vision and a pupil reflex defect (RAPD) on the same side. Other group: newly diagnosed giant cell arteritis, confirmed clinically and by ultrasound, with no vision loss or double vision, short-lived or lasting.
- Korábbi kezelés
- Cannot have had more than 5 days of prednisolone before joining.
A részvétel fő kizáró okai
- Metal implants that react to magnets (ferromagnetic implants)
- Severe kidney problems with eGFR < 30 mL/min/1.73m²
- Allergy to MRI contrast agents, or severe fear of closed spaces
- Pregnancy or breastfeeding
- Earlier documented optic neuropathy on the same side, or earlier giant cell arteritis
A regiszter feltételei, szó szerint
Mind a 13 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Ferromagnetic implants
- Previously documented ipsilateral optic neuropathy or giant cell arteritis
- More than 5 days of treatment with prednisolone prior to inclusion
- Allergy to MRI contrast agents
- Severe renal impairment with eGFR < 30 mL/min/1.73m²
- Severe claustrophobia
- Pregnancy or breastfeeding
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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 using PET/MRI and study subtle retinal changes using OCT images.
The investigators want to answer the following research questions:
Do patients with ischemic optic nerve disease and GCA show signs of inflammation in the orbital vessel wall on PET/MRI-scans, that are not present in patients with NAION?
Do GCA patients without vision loss, but with signs of orbital vessel wall inflammation on PET/MRI-scans, have a higher risk of later vision loss than GCA patients without?
Can subtle changes in the retina, detectable through OCT, help distinguish between GCA-related vision loss and NAION?
This will, to our knowledge, be the first study to systematically use FDG PET/MRI BB-scans to illuminate vascular changes in the orbit of patients with GCA and/or 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.
A vizsgálat 2 csoportja
- Anterior ischemic optic neuropathy (AION)
Adults aged 50 years or more with new onset AION, here defined as ipsilateral papilledema, visual impairment (affecting BCVA and/or visual field) and relative afferent pupillary defect (RAPD).
Kezelés: Positron Emission Tomography / Magnetic Resonance Imaging
- 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.
Kezelés: Positron Emission Tomography / Magnetic Resonance Imaging
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
- A regiszteradat frissítve
- 2026. május 7.