Actively Recruiting
Visual Involvement in Giant Cell Arteritis: An Observational Study Using Advanced Imaging to Compare Arteritic and Non-Arteritic Eye Conditions
Led by ASST Fatebenefratelli Sacco · Updated on 2024-07-15
762
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how Giant Cell Arteritis (GCA), a condition causing inflammation in medium and large arteries, affects vision. This study focuses on comparing eye problems caused by arteritic and non-arteritic forms of visual impairment, such as Arteritic Anterior Ischemic Optic Neuropathy (A-AION) versus Non-Arteritic Anterior Ischemic Optic Neuropathy (NA-AION), and Central Retinal Artery Occlusion (CRAO) due to GCA versus other causes. The goal is to improve diagnosis and prediction of patient outcomes using advanced eye imaging and clinical evaluations. Participants undergo various eye tests including fluorescein and indocyanine green angiography, high-resolution Optical Coherence Tomography (OCT), and Angio-OCT at multiple time points: baseline, 48-72 hours, 7 days, 4 weeks, 12 weeks, and 26 weeks. Blood samples are taken at baseline and during follow-up visits to help understand disease progression. Patients receive standard care based on international guidelines for GCA, and assessments include detailed eye exams and internal and immuno-rheumatological evaluations. During the study, participants will have regular evaluations of visual acuity, fundus examination, and visual field testing. Eye imaging and clinical data are collected and analyzed to identify patterns and changes in visual impairment linked to GCA. The study will track how vision changes over six months and assess the relationship between clinical findings and eye imaging results to better understand the disease's impact on vision over time.
CONDITIONS
Brief Title
Visual Involvement in Giant Cell Arteritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years with clinically suspected or confirmed giant cell arteritis.
- Newly found visual involvement suspected or confirmed to be related to vasculitis.
- Ability to provide valid consent to participate in the study.
- Patients older than 18 years with newly diagnosed acute visual impairment showing GCA-like eye features but without vasculitis.
- Ability to provide valid consent to participate in the study.
You will not qualify if you...
- Pre-existing eye diseases that affect best visual acuity or eye examination results.
- Active infections affecting the eyes or surrounding areas, including viral, bacterial, fungal, parasitic infections, or treated tuberculosis and HIV, hepatitis B or C.
- Systemic inflammatory diseases not caused by GCA (unless in remission without treatment).
- Any other condition deemed by investigators to prevent safe participation in the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline and repeated assessments over 6 months
Participants undergo ophthalmological assessments including visual acuity, fundus, visual field, and may have fluorescein and indocyanine green angiography, high-resolution Optical Coherence Tomography (OCT), and angio-OCT to evaluate visual impairment related to giant cell arteritis or similar eye conditions.
6 visits: baseline, 48-72 hours, 7 ± 2 days, 4 ± 1 weeks, 12 ± 2 weeks, and 26 ± 2 weeks
Duration - 6 months
Participants are monitored over 6 months with repeated ophthalmological and clinical assessments to evaluate the evolution of visual impairment and response to therapy according to standard clinical practice.
Ongoing follow-up visits aligned with diagnostic evaluations
Trial Site Locations
Total: 1 location
1
ASST Fatebenefratelli-Sacco
Milan, Lombardy, Italy, 20157
Actively Recruiting
Research Team
E
Enrico Tombetti, Prof.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here