Menu
Not yet recruiting NCT07508514

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

— Observational Giant Cell Arteritis Temporal Arteritis Optic Nerve Diseases Diagnosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optic Nerve Sheath Ultrasound, Temporal artery ultrasound, Bloodwork : CRP and ESR.
Who it may be relevant to
Registry conditions: Giant Cell Arteritis, Temporal Arteritis, Optic Nerve Diseases, Diagnosis. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Change in mean ONSD (in mm) from day 0 to day 28 [Time frame: Day 28]
Secondary outcome measures (10)
  • Change in mean ONSD (in mm, using ultrasound) from day 0 to day 14 [Time frame: Day 14]
  • Change in mean ONSD (in mm, using ultrasound) from day 0 to month 2 [Time frame: Month 2]
  • Association between cumulative glucocorticoids (GCs, in mg) and ONSD (in mm, by ultrasound) [Time frame: Month 2]
  • Association between IV methylprednisolone (binary : yes or no) and ONSD (in mm, by ultrasound) [Time frame: Month 2]
  • Association between immunosuppressive therapy (categorical, documented using medication list) and ONSD (in mm, by ultrasound) [Time frame: Month 2]
  • ONSD threshold (from the SONIC-GCA trial) performance over time [Time frame: Month 2]
  • Time (in days) to ONSD normalization [Time frame: Month 2]
  • Association between inflammatory markers and ONSD [Time frame: Month 2]
  • Association between OGUS and ONSD [Time frame: Month 2]
  • Association between digital retinal fundoscopy and ONSD (in mm, by ultrasound) [Time frame: Month 2]

Eligibility criteria

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

1\) Concurrent participation in a blinded interventional pharmaceutical clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal — Montreal

Identifiers

NCT: NCT07508514 · 2026-3095

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗