Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA
SONIC-TIME
1 other identifier
observational
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2026
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2026
CompletedFirst Posted
Study publicly available on registry
April 2, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
April 2, 2026
October 1, 2025
1.7 years
March 23, 2026
March 31, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Day 28
Secondary Outcomes (10)
Change in mean ONSD (in mm, using ultrasound) from day 0 to day 14
Day 14
Change in mean ONSD (in mm, using ultrasound) from day 0 to month 2
Month 2
Association between cumulative glucocorticoids (GCs, in mg) and ONSD (in mm, by ultrasound)
Month 2
Association between IV methylprednisolone (binary : yes or no) and ONSD (in mm, by ultrasound)
Month 2
Association between immunosuppressive therapy (categorical, documented using medication list) and ONSD (in mm, by ultrasound)
Month 2
- +5 more secondary outcomes
Study Arms (1)
GCA group
Patients with new-onset GCA who completed the SONIC-GCA (main study) baseline visit and who received 48 hours or less of glucocorticoids and less or equal to 160mg of oral prednisone equivalent. Study visits : Baseline, then days 3, 7, 10, 14, 21, 28, and Month 2
Interventions
Optic nerve sheath ultrasound will be performed in combination with a digital retinal fundoscopy.
With measurement of the intima-media complex and calculation of the OGUS.
Eligibility Criteria
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.
You may qualify if:
- 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.
- Exposure to glucocorticoids for ≤ 48 hours and ≤ 160 mg prednisone-equivalent before baseline.
- Ability and willingness to provide written informed consent.
- Agreement to complete the SONIC-TIME intensive follow-up schedule.
You may not qualify if:
- \) Concurrent participation in a blinded interventional pharmaceutical clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J1C5, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jean-Paul Makhzoum, MD, MSc
CISSS du Nord-de-l'ile de Montreal
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinician-Scientist
Study Record Dates
First Submitted
March 23, 2026
First Posted
April 2, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
April 2, 2026
Record last verified: 2025-10