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

November 21, 2025 updated by: Alessandro Invernizzi, University of Milan
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • IRCCS San Raffaele Università Vita e Salute
      • Milan, Italy, 20157
        • ASST Fatebenefratelli Sacco P.O.L.Sacco
      • Reggio Emilia, Italy, 42122
        • AUSL Reggio Emilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients affected by non-infective uveitis
Those patients will be recruited from the routine clinical practice. The treatment choice is not pre-planned but it will be based on the treating physician's clinical decision.
Procedure: to improve clinical practice in treatment of non-infective uveitis
to identify the potential correlation between cytokine profiles and systemic immunosuppressive drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three months from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline vs three months
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.
baseline and three months
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Collaborators

IRCCS San Raffaele

Investigators

  • Principal Investigator: Alessandro Invernizzi, MD, University of Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2025

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

August 26, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Estimated)

December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIN_NIU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Each site will be co-owner of IPD. Date will be disclosed in aggregated form

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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