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

NCT ID: NCT07262437

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-15
• Study Completion Date: 2026-07-01

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.

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

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

to improve clinical practice in treatment of non-infective uveitis

Intervention Type: PROCEDURE

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

Interventions

to improve clinical practice in treatment of non-infective uveitis

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: collaborator

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Alessandro Invernizzi

Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandro Invernizzi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Milan

Locations

IRCCS San Raffaele Università Vita e Salute

Milan, , Italy

ASST Fatebenefratelli Sacco P.O.L.Sacco

Milan, , Italy

AUSL Reggio Emilia

Reggio Emilia, , Italy

Countries

Italy

Other Identifiers

PRIN_NIU

Identifier Type: -

Identifier Source: org_study_id