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Visual Involvement in Giant Cell Arteritis

Recruitingn/aAges 18 Years - anyAllASST Fatebenefratelli Sacco
NCT06500728 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This observational study aims to enhance the description of the different ways Giant Cell Arteritis (GCA) affects vision. The latest technology and knowledge are used to improve how we diagnose and predict patient outcomes. GCA is the most frequent vasculitis, an inflammation of vessels, in older adults. It involves large and medium-sized arteries and causes ischemic alterations such as stroke and blindness, through damage of extracranial arteries. The primary objective is to compare the frequency of the various ocular findings between the main alterations of arteritic and non-arteritic aetiology, such as Arteritic Anterior Ischemic Optic Neuropathy (A-AION) Vs. Non-Arteritic Anterior Ischemic Optic Neuropathy (NA-AION) or Central Retinal Artery Occlusion (CRAO) from GCA Vs. from other causes, through a comprehensive clinical and instrumental evaluation.

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📋 Eligibility rules (as published)
Inclusion Criteria: * For GCA group: * Patients older than 18 years with clinically suspected or confirmed gigantocellular arteritis. * Newly found visual involvement with suspected or confirmed correlation with vasculitis. * Ability to express valid consent to study enrolment. * For control group: * Patients older than 18 years with the ability to express valid consent to study enrolment. * Newly diagnosed acute visual impairment with GCA phenotypes (e.g. AION, CRAO) but without any correlation with vasculitis aetiology. Exclusion Criteria: * Pre-existing ophthalmological pathologies that may modify best visual acuity and/or alter ophthalmological semeiotics. * Concomitant active viral, bacterial, fungal and parasitic infections, including active or latent tuberculosis treated for less than 4 weeks and HIV, hepatitis C virus (HCV) /hepatitis B virus (HBV) infections, involving the eyes and orbital cavities. * Concomitant systemic inflammations not attributable to GCA (inflammatory diseases in treatment-free remission are not excluded). * Any other condition judged by the investigators to be a contraindication of eligibility
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What it tests

  • Fluorescein and Indocyanine green Angiography
  • High-resolution Optical Coherence Tomography
  • Angio-Optical Coherence Tomography
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Where

1 site
ASST Fatebenefratelli-Sacco
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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