Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGOBSERVATIONAL

Visual Involvement in Giant Cell Arteritis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

Fluorescein and Indocyanine green Angiography

The ophthalmologist frequently recommends fluorescein (FAG) and indocyanine green angiography (ICGA) at baseline (T0) to evaluate retinal and choroidal vascularisation. They can be repeated also after 48-72 hours (T1), 7 ± 2 days (T2), 4 ± 1 weeks (T3), 12 ± 2 weeks (T4) or 26 ± 2 weeks (T5).

DIAGNOSTIC_TEST

High-resolution Optical Coherence Tomography

The ophthalmologist often suggests performing HR-OCT initially (T0) to assess the width of the macula and optic nerve with potential signs of ischemic lesions in these areas. This assessment can also be repeated after 48-72 hours (T1), 7 ± 2 days (T2), 4 ± 1 weeks (T3), 12 ± 2 weeks (T4), or 26 ± 2 weeks (T5).

DIAGNOSTIC_TEST

Angio-Optical Coherence Tomography

The ophthalmologist often suggests OCT-A at the beginning (T0) to assess the retinal and choroidal vascularization. These tests can also be done after 48-72 hours (T1), 7 ± 2 days (T2), 4 ± 1 weeks (T3), 12 ± 2 weeks (T4), or 26 ± 2 weeks (T5).

Locations (1)

ASST Fatebenefratelli-Sacco
Milan, Lombardy, Italy