An interventional study of to improve clinical practice in treatment of non-infective uveitis in Uveitis Posterior Non-Infectious, Inflammation Eye and Uveitis, sponsored by University of Milan. Active, not recruiting at 3 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by University of Milan · Not applicable, Interventional, and Treatment
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.
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
55 studies on the registry are indexed under Endophthalmitis; 8 are open to participants now.
This study's planned enrollment of 220 is above the median of 113 across 32 interventional studies indexed under Endophthalmitis.
Browse Endophthalmitis studies →University of Milan is the lead sponsor of 177 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: Three months from baseline
Correlation cytokine profiles and patients' clinical evaluation
Correlation between patients' demographics, uveitis type, uveitis etiology, and duration with the cytokine profiles in the aqueous humor.
Time frame: Baseline vs three months
Correlation between clinical ophthalmic features and cytokine profiles
Correlation between clinical ophthalmic features and cytokine profiles in the aqueous humor.
Time frame: baseline and three months
Correlation between cytokine levels in the aqueous humor and blood
Comparison between cytokine levels in the aqueous humor and those in the plasma to identify differential expression in the two compartments.
Time frame: Baseline
Plan to share: Yes — Each site will be co-owner of IPD. Date will be disclosed in aggregated form
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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University of Milan