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 methylprednisolone, and early use of steroid-sparing therapies.
Sixty participants with newly diagnosed GCA will undergo serial optic nerve sheath ultrasound, blood tests (CRP, ESR), and when feasible, temporal artery ultrasound over the first two months of therapy (Days 3, 7, 10, 14, 21, 28, and Month 2). No experimental treatments are given; all participants receive standard-of-care therapy.
The primary objective is to quantify the percent change in mean ONSD from baseline to Day 28. Secondary objectives include modeling ONSD change over time, assessing associations with cumulative steroid dose and inflammatory markers, and estimating the time to normalization below the SONIC-GCA cutoff. Findings will define the optimal imaging window and refine the diagnostic and monitoring role of optic nerve ultrasound in GCA.
completed the baseline optic nerve sheath ultrasound
confirmed GCA as determined by the baseline standardized GCA assessment in SONIC-GCA.
Exposure to glucocorticoids for ≤ 48 hours and ≤ 160 mg prednisone-equivalent before baseline.
Ability and willingness to provide written informed consent.
None
Eligible patients will consist of those who consult at our GCA fast-track clinic, have completed the SONIC-GCA baseline procedures, and have received a diagnosis of GCA on that visit.
Cohort
Prospective
Optic Nerve Sheath Ultrasound
Diagnostic testOptic nerve sheath ultrasound will be performed in combination with a digital retinal fundoscopy.
Temporal artery ultrasound
Diagnostic testWith measurement of the intima-media complex and calculation of the OGUS.
Bloodwork : CRP and ESR
Diagnostic testAt each visit
Change in mean ONSD (in mm) from day 0 to day 28
To quantify the change in mean ONSD (in mm, by ultrasound) between baseline (Day 0) and Day 28 after GC initiation in patients with GCA exposed to ≤ 48 hours and ≤ 120 mg prednisone-equivalent before baseline.
Change in mean ONSD (in mm, using ultrasound) from day 0 to day 14
To quantify the change in mean ONSD between baseline (Day 0) and Day14 after GC initiation in patients with GCA exposed to ≤ 48 hours and ≤ 120 mg prednisone-equivalent before baseline.
Change in mean ONSD (in mm, using ultrasound) from day 0 to month 2
To model ONSD change over the first eight weeks using with time-updated cumulative GC exposure.
Association between cumulative glucocorticoids (GCs, in mg) and ONSD (in mm, by ultrasound)
To determine the dose-response relationship between ONSD and cumulative GC exposure.
Association between IV methylprednisolone (binary : yes or no) and ONSD (in mm, by ultrasound)
To evaluate the influence of IV methylprednisolone on ONSD evolution.
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