Uveitis Posterior Non-InfectiousPRIN_NIUNCT07262437
Targeting Immunosuppressive Treatment for Non-infectious Uveitis Using Aqueous Humor Cytokine Profiles
A study testing to improve clinical practice in treatment of non-infective uveitis in people with Uveitis Posterior Non-Infectious and Inflammation Eye, run by University of Milan at 3 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis Posterior Non-Infectious, Inflammation Eye, Uveitis
- What is being tested?
- to improve clinical practice in treatment of non-infective uveitis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesItaly
- Study dates
- 15 Nov 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Italy3 sites
IRCCS San Raffaele Università Vita e Salute
Milan, 20132
ASST Fatebenefratelli Sacco P.O.L.Sacco
Milan, 20157
AUSL Reggio Emilia
Reggio Emilia, 42122
About this study
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.
Read the 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
- Being tested
- to improve clinical practice in treatment of non-infective uveitis
- Keywords
- non-infectious uveitis, cytokines, aqueous humor, inflammation
- Medical subject headings
- Endophthalmitis, Uveitis, Uveitis, Anterior, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
to improve clinical practice in treatment of non-infective uveitisProcedure or surgery
to identify the potential correlation between cytokine profiles and systemic immunosuppressive drug.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: to improve clinical practice in treatment of non-infective uveitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months from baseline
Secondary outcomes (3)
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.
Measured: Baseline vs three months
Correlation between clinical ophthalmic features and cytokine profiles
Correlation between clinical ophthalmic features and cytokine profiles in the aqueous humor.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start15 Nov 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis Posterior Non-InfectiousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS San Raffaele
- Responsible party
- Principal investigator, Alessandro Invernizzi, University of Milan
- Investigators
- Alessandro Invernizzi, MD, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262437
- Sponsor's protocol ID
- PRIN_NIU
- Acronym
- PRIN_NIU
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Each site will be co-owner of IPD. Date will be disclosed in aggregated form
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Immunosuppressive Treatment for Non-infectious Uveitis Using Aqueous Humor Cytokine Profiles
- ClinicalTrials.gov ID
- NCT07262437
- Acronym / sponsor ID
- PRIN_NIU / PRIN_NIU
- Keywords
- non-infectious uveitis, cytokines, aqueous humor, inflammation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- IRCCS San Raffaele
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients affected by non-infective uveitis | Experimental | Procedure: to improve clinical practice in treatment of non-infective uveitisThose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| to improve clinical practice in treatment of non-infective uveitisto identify the potential correlation between cytokine profiles and systemic immunosuppressive drug. | Procedure or surgery | Patients affected by non-infective uveitis |
Primary outcome
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.
3 secondary outcomes
Correlation cytokine profiles and patients' clinical evaluation
Time frame: Baseline vs three months
Correlation between clinical ophthalmic features and cytokine profiles
Time frame: baseline and three months
Correlation between cytokine levels in the aqueous humor and blood
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Yes. Each site will be co-owner of IPD. Date will be disclosed in aggregated form
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Invernizzi, MD principal investigator
University of Milan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing to improve clinical practice in treatment of non-infective uveitis in people with Uveitis Posterior Non-Infectious and Inflammation Eye, run by University of Milan at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aqueous humor cytokine profile characterization in responders vs non-responders using multiplex immunoassay techniques. (time frame: Three months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.