NCT07508514 Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA
| NCT ID | NCT07508514 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal |
| Condition | Giant Cell Arteritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2026-05-01 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Jean-Paul Makhzoum, MD, MSc
STUDY CHAIR
CISSS du Nord-de-l'ile de Montreal
Frequently Asked Questions
Who can join the NCT07508514 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Giant Cell Arteritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07508514 currently recruiting?
Yes, NCT07508514 is actively recruiting participants. Contact the research team at jean-paul.makhzoum@umontreal.ca for enrollment information.
Where is the NCT07508514 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT07508514 clinical trial?
NCT07508514 is sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal. The principal investigator is Jean-Paul Makhzoum, MD, MSc at CISSS du Nord-de-l'ile de Montreal. The trial plans to enroll 60 participants.