Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| IRCCS San Raffaele | OTHER |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| to improve clinical practice in treatment of non-infective uveitis | Procedure | to identify the potential correlation between cytokine profiles and systemic immunosuppressive drug. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline vs three months |
| Correlation between clinical ophthalmic features and cytokine profiles |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Invernizzi, MD | University of Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Università Vita e Salute | Milan | 20132 | Italy | |||
| ASST Fatebenefratelli Sacco P.O.L.Sacco |
Each site will be co-owner of IPD. Date will be disclosed in aggregated form
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Correlation between clinical ophthalmic features and cytokine profiles in the aqueous humor. |
| 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. | Baseline |
| Milan |
| 20157 |
| Italy |
| AUSL Reggio Emilia | Reggio Emilia | 42122 | Italy |
| ID | Term |
|---|---|
| D009877 | Endophthalmitis |
| D014605 | Uveitis |
| D014606 | Uveitis, Anterior |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007239 | Infections |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D015864 | Panuveitis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided