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Recruiting NCT06500728

Visual Involvement in Giant Cell Arteritis

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Trial Parameters

Condition Giant Cell Arteritis
Sponsor ASST Fatebenefratelli Sacco
Study Type OBSERVATIONAL
Phase N/A
Enrollment 762
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-06-27
Completion 2028-06
Interventions
Fluorescein and Indocyanine green AngiographyHigh-resolution Optical Coherence TomographyAngio-Optical Coherence Tomography

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Brief Summary

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.

Eligibility Criteria

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 dis

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