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

N/ANot Yet RecruitingNCT07508514

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal60 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Giant Cell Arteritis Temporal Arteritis Optic Nerve Diseases

Interventions

Optic Nerve Sheath UltrasoundDIAGNOSTIC_TEST

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

Temporal artery ultrasoundDIAGNOSTIC_TEST

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

Bloodwork : CRP and ESRDIAGNOSTIC_TEST

At each visit

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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.

Time frame: Day 28

Secondary Outcomes

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

Time frame: Day 14

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

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

Time frame: Month 2

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

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

Time frame: Month 2

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

To evaluate the influence of IV methylprednisolone on ONSD evolution.

Time frame: Month 2

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

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

Time frame: Month 2

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

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

Time frame: Month 2

Time (in days) to ONSD normalization

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

Time frame: Month 2

Association between inflammatory markers and ONSD

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

Time frame: Month 2

Association between OGUS and ONSD

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

Time frame: Month 2

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

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

Time frame: Month 2

Central Contacts

Jean-Paul Makhzoum, MD, MSc

CONTACT

514-338-2222 jean-paul.makhzoum@umontreal.ca

Data from ClinicalTrials.gov

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