Status:
RECRUITING
Visual Involvement in Giant Cell Arteritis
Lead Sponsor:
ASST Fatebenefratelli Sacco
Conditions:
Giant Cell Arteritis
Visual Impairment
Eligibility:
All Genders
18+ years
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 pr...
Detailed Description
Giant-cell arteritis (GCA) is an idiopathic inflammatory condition affecting medium- and large-sized arteries. This condition typically affects females over 50, with a peak incidence in the eighth dec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 27 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
762 Patients enrolled
Trial Details
Trial ID
NCT06500728
Start Date
June 27 2024
End Date
June 1 2030
Last Update
July 15 2024
Active Locations (1)
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1
ASST Fatebenefratelli-Sacco
Milan, Lombardy, Italy, 20157