Visual Involvement in Giant Cell Arteritis

Recruiting now

Conditions studied: Giant Cell Arteritis, Visual Impairment, Central Retinal Artery Occlusion, Anterior Ischemic Optic Neuropathy, Paracentral Acute Middle Maculopathy, Posterior Ischemic Optic Neuropathy, Retinal Ischemia, Blindness, Visual Disorder

In brief

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.

Key facts

Study ID

NCT06500728

Run by

ASST Fatebenefratelli Sacco

People needed

762

Starts

2024-06-27

Expected to finish

2030-06-01

Last updated by the study team

2024-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• ASST Fatebenefratelli-Sacco — Milan, Lombardy, Italy (enrolling)

Full record on ClinicalTrials.gov

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