NCT06500728 Visual Involvement in Giant Cell Arteritis
| NCT ID | NCT06500728 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ASST Fatebenefratelli Sacco |
| Condition | Giant Cell Arteritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 762 participants |
| Start Date | 2024-06-27 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 762 participants in total. It began in 2024-06-27 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 diseases in treatment-free remission are not excluded). * Any other condition judged by the investigators to be a contraindication of eligibility
Contact & Investigator
Alessandro Invernizzi, Prof.
PRINCIPAL INVESTIGATOR
ASST Fatebenefratelli Sacco
Frequently Asked Questions
Who can join the NCT06500728 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Giant Cell Arteritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06500728 currently recruiting?
Yes, NCT06500728 is actively recruiting participants. Contact the research team at tombetti.enrico@asst-fbf-sacco.it for enrollment information.
Where is the NCT06500728 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06500728 clinical trial?
NCT06500728 is sponsored by ASST Fatebenefratelli Sacco. The principal investigator is Alessandro Invernizzi, Prof. at ASST Fatebenefratelli Sacco. The trial plans to enroll 762 participants.