Recruiting

Glucocorticoids

Sponsor:

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Code:

NCT07508514

Conditions

Giant Cell Arteritis

Temporal Arteritis

Optic Nerve Diseases

Diagnosis

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Optic Nerve Sheath Ultrasound

Temporal artery ultrasound

Bloodwork : CRP and ESR

Study Details

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.

Conditions

Giant Cell Arteritis

Temporal Arteritis

Optic Nerve Diseases

Diagnosis

Study ID

NCT07508514

Start date

May 1, 2026

Status verified date

Oct, 2026

Completion date

May 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Optic nerve sheath ultrasound will be performed in combination with a digital retinal fundoscopy.

Temporal artery ultrasound

With measurement of the intima-media complex and calculation of the OGUS.

Bloodwork : CRP and ESR

At each visit

Primary outcome measure

  • Change in mean ONSD (in mm) from day 0 to day 28 [ Time Frame: Day 28 ]

Central Contacts and Locations

Central contacts

Locations

Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal

Recruiting

Montreal, Quebec, Canada, H4J1C5

Contacts

Principal Investigator:

Jean-Paul Makhzoum, MD

More Information

Sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Last update posted

Oct 21, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.