Visual Involvement in Giant Cell Arteritis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorASST Fatebenefratelli Sacco

About this trial

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

Qualifiers

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.

Patients older than 18 years with the ability to express valid consent to study enrolment.

Disqualifiers

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)

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

Trial design

Treatments tested in this trial

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

Treatment groups

762 Participants
are divided into 2 treatment groups

Sponsors and collaborators