Inflammation Eye, Uveitis, Uveitis, Anterior, Uveitis Posterior Non-Infectious
Conditions
Keywords
non-infectious uveitis, cytokines, aqueous humor, inflammation
Brief summary
This multicenter, prospective, interventional, non-pharmacological study aims to investigate whether the intraocular cytokine profile is associated with the therapeutic response to immunosuppressive drugs in patients with non-infectious uveitis (NIU). Approximately 220 patients with NIU in at least one eye, showing inadequate response to topical or systemic corticosteroids at baseline and presenting with signs of anterior segment inflammation, will be enrolled to enhance sensitivity to laboratory assays. Aqueous humor and blood samples will be collected at baseline. Cytokine concentrations of 14 different cytokines will be measured using multiplex immunoassay techniques. Participants will receive immunosuppressive treatment based on standard clinical practice.
Detailed description
This project is coordinated by University of Milan/ ASST FBF Sacco Milan Italy. Site coordinator has a sub-Unit (AUSL Reggio Emilia Italy) which act both as recruiter and Lab analyst. Site co-partner is: IRCCS San Raffaele, University Vita e Salute San Raffaele Milan Italy
Interventions
PROCEDUREto improve clinical practice in treatment of non-infective uveitis
to identify the potential correlation between cytokine profiles and systemic immunosuppressive drug.
Sponsors
IRCCS San Raffaele
University of Milan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of non-infectious uveitis in at least one eye with incomplete or not sustained response to topic or systemic steroids at the baseline visit * Evidence of anterior chamber inflammation to optimize lab sensibility * As per clinical practice eligibility to receive one of the following immunosuppressive treatment: mycophenolate mofetil (MMF), methotrexate (MTX), azatioprine (AZA), adalimumab (ADA) * Ability to provide informed consent
Exclusion criteria
* Concomitant immunosuppressive treatment * Presence of other systemic pathologies that do not allow immunosuppressive therapies * Ocular media opacities that could interfere with a good quality of fundus exam and/or imaging of the eye * Any ocular or systemic condition that could interfere with cytokine profile expressions * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aqueous humor cytokine profile characterization in responders vs non-responders using multiplex immunoassay techniques. | Three months from baseline | Distribution of responders and non responders to each study drug according to baseline cytokine profile in the aqueous humor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation cytokine profiles and patients' clinical evaluation | Baseline vs three months | Correlation between patients' demographics, uveitis type, uveitis etiology, and duration with the cytokine profiles in the aqueous humor. |
| Correlation between clinical ophthalmic features and cytokine profiles | baseline and three months | Correlation between clinical ophthalmic features and cytokine profiles in the aqueous humor. |
| Correlation between cytokine levels in the aqueous humor and blood | Baseline | Comparison between cytokine levels in the aqueous humor and those in the plasma to identify differential expression in the two compartments. |
Countries
Italy
Outcome results
None listed