How optic nerve swelling changes after starting steroids in giant cell arteritis
Official title: Early Temporal Dynamics of Optic Nerve Sheath Diameter After Glucocorticoid Therapy in Giant Cell Arteritis
Run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · NCT07508514 · Data updated 2026-11-12
This study tests how quickly the optic nerve sheath swelling decreases after starting glucocorticoids in people with newly diagnosed giant cell arteritis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Montreal, Quebec) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | January 1, 2029 |
| Study ends | May 1, 2029 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT07508514 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with newly diagnosed giant cell arteritis who are enrolled in the related SONIC-GCA study and meet specific treatment timing criteria.
✕Probably not a fit
Patients who have already received high-dose steroids beyond the included time window or who cannot undergo follow-up ultrasound may not benefit from this substudy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective observational substudy embedded in a larger GCA study. Researchers will measure optic nerve sheath diameter with ultrasound and track inflammation markers to see how the swelling changes over time after glucocorticoid therapy. The goal is to understand the temporal dynamics of inflammation and how treatment intensity affects the trajectory. Findings may help interpret imaging tests taken after treatment begins and guide future management.
Why it matters
Potential benefit: If successful, it could clarify how soon optic nerve swelling responds to steroids, aiding early assessment and treatment decisions.
How similar studies have gone: Other studies have shown that imaging biomarkers can reflect treatment response in inflammatory arteritis, but this is a novel look at optic nerve sheath changes in relation to GC exposure.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participants must be enrolled in SONIC-GCA and must have: * completed the baseline optic nerve sheath ultrasound * confirmed GCA as determined by the baseline standardized GCA assessment in SONIC-GCA. 2. Exposure to glucocorticoids for ≤ 48 hours and ≤ 160 mg prednisone-equivalent before baseline. 3. Ability and willingness to provide written informed consent. 4. Agreement to complete the SONIC-TIME intensive follow-up schedule. Exclusion Criteria: 1\) Concurrent participation in a blinded interventional pharmaceutical clinical trial.
Where it's running
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Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada Recruiting
Study contacts
- Study coordinator: Jean-Paul Makhzoum, MD, MSc
- Email: jean-paul.makhzoum@umontreal.ca
- Phone: 514-338-2222
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.