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

University of Milan

Status: Active, not recruiting

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

Treatments: Procedure: to improve clinical practice in treatment of non-infective uveitis

Study type: Interventional

Funder types: Other

Identifiers

NCT07262437

PRIN_NIU

Details and patient eligibility

About

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.

Full 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

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 1 patient group

Patients affected by non-infective uveitis

Experimental group

Description:

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.

Treatment:

Procedure: to improve clinical practice in treatment of non-infective uveitis