Actively Recruiting
Orbital Vascular Inflammation in Ischemic Optic Neuropathy and Giant Cell Arteritis
Led by Rigshospitalet, Denmark · Updated on 2026-05-07
122
Participants Needed
1
Research Sites
12 weeks
Total Duration
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AI-Summary
What this Trial Is About
Giant cell arteritis (GCA) is an inflammation of blood vessels that can cause serious complications like sudden vision loss due to reduced blood flow to the optic nerve. It is important to distinguish this condition from non-arteritic ischemic optic neuropathy (NAION), a similar cause of vision loss that does not benefit from anti-inflammatory treatment. This research aims to study these conditions using advanced imaging techniques to better understand vascular inflammation and retinal changes. The study uses FDG PET/MRI with Black Blood sequences and Optical Coherence Tomography (OCT) to examine inflammation in the small vessels of the eye orbit and subtle retinal changes. It includes two groups: adults aged 50 or older with new onset anterior ischemic optic neuropathy (AION) and adults 50 or older newly diagnosed with GCA without vision loss. The study will assess differences in imaging markers of inflammation and retinal abnormalities between A-AION and NAION, and track vision loss risk in GCA patients over time. Participants will undergo PET/MRI and OCT imaging to measure sugar metabolism, vessel wall changes, and retinal biomarkers. Researchers will monitor participants for up to 2 years to observe ocular complications and correlate imaging findings with clinical diagnosis. The study focuses on improving diagnosis and treatment decisions for GCA and NAION by identifying vascular inflammation and retinal changes that help distinguish these conditions and predict vision loss risk.
CONDITIONS
Brief Title
Orbital Vascular Inflammation in Ischemic Optic Neuropathy and Giant Cell Arteritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 50 years or older with newly onset ischemic optic neuropathy characterized by papilledema, visual impairment, and relative afferent pupillary defect
- Adults aged 50 years or older with clinically and ultrasound-confirmed newly diagnosed giant cell arteritis
- GCA patients without permanent or transient vision loss or double vision
You will not qualify if you...
- Presence of ferromagnetic implants
- Severe renal impairment with eGFR below 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 prednisolone treatment prior to inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial assessment with possible follow-up imaging up to 2 years
Participants undergo FDG PET/MRI with Black Blood sequences of the head and neck area to assess orbital vascular inflammation and retinal changes related to ischemic optic neuropathy and giant cell arteritis.
1 baseline imaging visit with possible additional imaging assessments
Duration - Up to 2 years
Participants are observed for the development of ocular complications, structural and functional eye changes, and retinal abnormalities over time to better understand disease progression and risk.
Periodic follow-up visits during 2-year observation period
Trial Site Locations
Total: 1 location
1
Rigshospitalet - Glostrup
Glostrup Municipality, Denmark, 2600
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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