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Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA

Recruitingn/aAges 50 Years - anyAllCentre Integre Universitaire de Sante et Services…
NCT07508514 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Giant cell arteritis (GCA) is an inflammatory disease of large and medium arteries that can cause irreversible vision loss. Glucocorticoids (GCs) rapidly suppress inflammation, but diagnostic imaging tests such as temporal artery ultrasound or biopsy often become falsely negative within days of treatment. The optic nerve sheath diameter (ONSD), measurable by ocular ultrasound, reflects perineural edema and may serve as a quantitative biomarker of ocular inflammation in GCA. The SONIC-TIME study (Early Temporal Dynamics of Optic Nerve Sheath Diameter After Glucocorticoid Therapy in Giant Cell Arteritis) is a single-center, prospective observational substudy embedded within SONIC-GCA (NCT05749094) at Hôpital du Sacré-Cœur de Montréal. It aims to characterize how rapidly ONSD decreases after GC initiation and how this trajectory relates to cumulative GC exposure, intravenous methylpredniso

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📋 Eligibility rules (as published)
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.
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What it tests

  • Optic Nerve Sheath Ultrasound
  • Temporal artery ultrasound
  • Bloodwork : CRP and ESR
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Where

1 site
Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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