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Clinical Trials in Italy / NCT07262437
Active, not recruiting Not applicable

Targeting Immunosuppressive Treatment for Non-infectious Uveitis Using Aqueous Humor Cytokine Profiles

NCT07262437 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Milan
Phase
Not applicable
Started
2025-11-15
Last updated
2025-12-03

Condition(s) studied

Uveitis Posterior Non-InfectiousInflammation EyeUveitisUveitis, Anterior

Investigational drug(s) / intervention(s)

to improve clinical practice in treatment of non-infective uveitis

to improve clinical practice in treatment of non-infective uveitis: to identify the potential correlation between cytokine profiles and systemic immunosuppressive drug.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • 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.

Trial sites (3)

FacilityCityRegionStatus
IRCCS San Raffaele Università Vita e Salute Milan Italy
ASST Fatebenefratelli Sacco P.O.L.Sacco Milan Italy
AUSL Reggio Emilia Reggio Emilia Italy

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Other trials for the same condition

RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age Recruiting
Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial Starting soon
A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis Active, not recruiting
A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07262437 on ClinicalTrials.gov ↗ ← All trials in Italy