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NCT Number: NCT07262437

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

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.

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Key information

Conditions

Uveitis Posterior Non-Infectious Endophthalmitis Eye Diseases Eye Infections Infections Inflammation Inflammation Eye Panuveitis Pathologic Processes Pathological Conditions, Signs and Symptoms Uveal Diseases Uveitis Uveitis, Anterior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASST Fatebenefratelli Sacco P.O.L.Sacco, Milan, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

to improve clinical practice in treatment of non-infective uveitis

Procedure

to identify the potential correlation between cytokine profiles and systemic immunosuppressive drug.

Primary outcomes

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

    Time frame: Three months from baseline

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

Secondary outcomes

  1. Correlation cytokine profiles and patients' clinical evaluation

    Time frame: Baseline vs three months

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

  2. Correlation between clinical ophthalmic features and cytokine profiles

    Time frame: baseline and three months

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

  3. Correlation between cytokine levels in the aqueous humor and blood

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Collaborators

  • IRCCS San Raffaele

Registry information

Acronym: PRIN_NIU

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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