RecruitingNCT07206238

Orbital Vascular Inflammation in Ischemic Optic Neuropathy and Giant Cell Arteritis


Sponsor

Rigshospitalet, Denmark

Enrollment

122 participants

Start Date

Jan 14, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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 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.


Eligibility

Min Age: 50 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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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Interventions

DIAGNOSTIC_TESTPositron Emission Tomography / Magnetic Resonance Imaging

FDG PET/MRI with Black Blood sequences of the head and neck area.


Locations(1)

Rigshospitalet - Glostrup

Glostrup Municipality, Denmark

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NCT07206238


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