NCT07508514

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

Early Temporal Dynamics of Optic Nerve Sheath Diameter After Glucocorticoid Therapy in Giant Cell Arteritis

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Giant Cell Arteritis
• Temporal Arteritis
• Optic Nerve Diseases
• Diagnosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Optic Nerve Sheath Ultrasound	Optic nerve sheath ultrasound will be performed in combination with a digital retinal fundoscopy.
DIAGNOSTIC_TEST	Temporal artery ultrasound	With measurement of the intima-media complex and calculation of the OGUS.
DIAGNOSTIC_TEST	Bloodwork : CRP and ESR	At each visit

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-01-01
• Completion: 2028-05-01
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: Canada