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

NCT07262437 | Active Not Recruiting DMC

• 1 other identifier: PRIN_NIU
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 3

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.

Conditions

Uveitis Posterior Non-Infectious; Inflammation Eye; Uveitis; Uveitis, Anterior

Keywords

non-infectious uveitis; cytokines; aqueous humor; inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  Three months from baseline

Secondary Outcomes (3)

• Correlation cytokine profiles and patients' clinical evaluation

  Baseline vs three months

• Correlation between clinical ophthalmic features and cytokine profiles

  baseline and three months

• Correlation between cytokine levels in the aqueous humor and blood

  Baseline

Study Arms (1)

Patients affected by non-infective uveitis

EXPERIMENTAL

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

Interventions

to improve clinical practice in treatment of non-infective uveitis PROCEDURE

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

Patients affected by non-infective uveitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead
• IRCCS San Raffaele: collaborator

Study Sites (3)

IRCCS San Raffaele Università Vita e Salute

Milan, 20132, Italy

Location

ASST Fatebenefratelli Sacco P.O.L.Sacco

Milan, 20157, Italy

Location

AUSL Reggio Emilia

Reggio Emilia, 42122, Italy

Location

MeSH Terms

Conditions

Endophthalmitis; Uveitis; Uveitis, Anterior; Inflammation

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases; Uveal Diseases; Panuveitis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alessandro Invernizzi, MD

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: December 3, 2025
• Study Start: November 15, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

IT (3)