Understanding how Giant Cell Arteritis affects vision
Visual Involvement in Giant Cell Arteritis
ASST Fatebenefratelli Sacco · NCT06500728
This study is trying to understand how Giant Cell Arteritis affects vision in adults by comparing eye health in those with GCA-related vision problems to those with other causes of vision loss.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 762 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ASST Fatebenefratelli Sacco (other) |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT06500728 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the understanding of how Giant Cell Arteritis (GCA) impacts visual health. By utilizing advanced imaging technologies such as High-resolution Optical Coherence Tomography and Angio-Optical Coherence Tomography, the study will compare ocular findings in patients with GCA-related visual impairment against those with non-arteritic causes. The goal is to improve diagnostic accuracy and predict patient outcomes based on the observed ocular manifestations. The study focuses on patients over 18 years old who either have confirmed GCA or acute visual impairment linked to GCA.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with clinically suspected or confirmed Giant Cell Arteritis and newly found visual involvement.
Not a fit: Patients with pre-existing ophthalmological conditions or other systemic inflammations unrelated to GCA may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnosis and management of visual complications in patients with Giant Cell Arteritis.
How similar studies have performed: While there have been studies on GCA, this specific approach using advanced imaging techniques for visual involvement is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan, Lombardy
- ASST Fatebenefratelli-Sacco — Milan, Lombardy, Italy (RECRUITING)
Study contacts
- Principal investigator: Alessandro Invernizzi, Prof. — ASST Fatebenefratelli Sacco
- Study coordinator: Enrico Tombetti, Prof.
- Email: tombetti.enrico@asst-fbf-sacco.it
- Phone: 3289098793
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Giant Cell Arteritis, Visual Impairment, Central Retinal Artery Occlusion, Anterior Ischemic Optic Neuropathy, Paracentral Acute Middle Maculopathy, Posterior Ischemic Optic Neuropathy, Retinal Ischemia, Blindness