Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07508514

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Giant Cell Arteritis Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cranial Nerve Diseases Diagnosis Disease Eye Diseases Immune System Diseases Nervous System Diseases Optic Nerve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Temporal Arteritis Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J1C5, Canada

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Concurrent participation in a blinded interventional pharmaceutical clinical trial.

Treatment and study plan

Optic Nerve Sheath Ultrasound

Diagnostic Test

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

Temporal artery ultrasound

Diagnostic Test

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

Bloodwork : CRP and ESR

Diagnostic Test

At each visit

Primary outcomes

  1. Change in mean ONSD (in mm) from day 0 to day 28

    Time frame: 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.

Secondary outcomes

  1. Change in mean ONSD (in mm, using ultrasound) from day 0 to day 14

    Time frame: 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.

  2. Change in mean ONSD (in mm, using ultrasound) from day 0 to month 2

    Time frame: Month 2

    To model ONSD change over the first eight weeks using with time-updated cumulative GC exposure.

  3. Association between cumulative glucocorticoids (GCs, in mg) and ONSD (in mm, by ultrasound)

    Time frame: Month 2

    To determine the dose-response relationship between ONSD and cumulative GC exposure.

  4. Association between IV methylprednisolone (binary : yes or no) and ONSD (in mm, by ultrasound)

    Time frame: Month 2

    To evaluate the influence of IV methylprednisolone on ONSD evolution.

  5. Association between immunosuppressive therapy (categorical, documented using medication list) and ONSD (in mm, by ultrasound)

    Time frame: Month 2

    To assess the impact of early initiated steroid-sparing therapies initiated as standard of care on ONSD trajectory.

  6. ONSD threshold (from the SONIC-GCA trial) performance over time

    Time frame: Month 2

    To evaluate the time-adjusted ONSD performance based on the established SONIC-GCA ONSD cutoff.

  7. Time (in days) to ONSD normalization

    Time frame: Month 2

    To estimate the adjusted time to first attainment of an ONSD value below the established SONIC-GCA ONSD cutoff.

  8. Association between inflammatory markers and ONSD

    Time frame: Month 2

    To quantify correlations between ONSD and systemic inflammatory biomarkers over the early therapy period.

  9. Association between OGUS and ONSD

    Time frame: Month 2

    To examine associations between ONSD and the temporal artery ultrasound OGUS score over the early therapy period.

  10. Association between digital retinal fundoscopy and ONSD (in mm, by ultrasound)

    Time frame: Month 2

    To compare ONSD trajectories between participants with and without GCA-related retinal abnormalities on digital retinal fundoscopy.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Paul Makhzoum, MD, MSc

CONTACT

[email protected]

514-338-2222

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: SONIC-TIME

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.