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

N/AActive Not RecruitingNCT07262437

University of Milan220 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Uveitis Posterior Non-Infectious Inflammation Eye

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

IRCCS San Raffaele Università Vita e Salute

Milan, Italy

ASST Fatebenefratelli Sacco P.O.L.Sacco

Milan, Italy

AUSL Reggio Emilia

Reggio Emilia, Italy

Outcomes

Primary Outcomes

Aqueous humor cytokine profile characterization in responders vs non-responders using multiplex immunoassay techniques.

Distribution of responders and non responders to each study drug according to baseline cytokine profile in the aqueous humor.

Time frame: Three months from baseline

Secondary Outcomes

Correlation cytokine profiles and patients' clinical evaluation

Correlation between patients' demographics, uveitis type, uveitis etiology, and duration with the cytokine profiles in the aqueous humor.

Time frame: Baseline vs three months

Correlation between clinical ophthalmic features and cytokine profiles

Correlation between clinical ophthalmic features and cytokine profiles in the aqueous humor.

Time frame: baseline and three months

Correlation between cytokine levels in the aqueous humor and blood

Comparison between cytokine levels in the aqueous humor and those in the plasma to identify differential expression in the two compartments.

Time frame: Baseline