Status:
NOT_YET_RECRUITING
Orbital Vascular Inflammation in Ischemic Optic Neuropathy and Giant Cell Arteritis
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Giant Cell Arteritis (GCA)
Ischemic Optic Neuropathy
Eligibility:
All Genders
50+ years
Brief 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 t...
Detailed Description
Rationale and problem statement: Giant cell arteritis (GCA) is an immune-driven inflammatory condition affecting the walls of blood vessels. Untreated, GCA can cause vessel wall thickening severe eno...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 17 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2028
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT07206238
Start Date
November 17 2025
End Date
March 30 2028
Last Update
November 18 2025
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