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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04354909
Other study ID # CHUBX 2019/43
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 17, 2020
Est. completion date March 10, 2023

Study information

Verified date May 2024
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aims at defining the role of soluble CD95 Ligand in the physiopathology of the non-infectious uveitis. Soluble CD95 Ligand might have a prognostic interest as well as potential for the discovery of new therapeutic strategies


Description:

Non-Infectious active uveitis is a severe inflammatory ocular disease which can expose to the blindness. Actually, the knowledge of the physiopathology of uveitis stay poorly. CD95 Ligand (CD95-L) belongs to a TNF (tumor necrosis factors) receptor family. It knows to play a preponderant role to maintain the eye immune privilege. In particular conditions depending on immunologic environment, CD95-L has pro-inflammatory properties and can interact with Th17 lymphocytes and neutrophils, two cells implicated in non-infectious uveitis. The hypothesis is that s-CD95-L levels might be a prognostic factor in non-infectious uveitis and the study of the molecular mechanisms involved could provide new therapeutic targets. This study will recruit 100 patients with non-infectious uveitis followed in Bordeaux University Hospital. Among classical disease activity information, blood samples will be collected during to assess s-CD95-L. Fundamental research will be realized on patients' sample to evaluate underlying molecular mechanisms. Clinical and biological disease activity, treatment and outcomes will be studied in correlation with s-CD95-L to describe their potential prognostic role. Patients will be followed at regular intervals, accordingly to usual care.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 10, 2023
Est. primary completion date March 10, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of non-infectious uveitis according to the SUN (Standardization of the Uveitis Nomenclature) working Group; - Age = 18 years; - being affiliated to health insurance, - willing to participate. Exclusion Criteria: - Pregnant or breastfeeding women, - patient under legal protection measure , - poor understanding of the French language

Study Design


Related Conditions & MeSH terms


Intervention

Other:
s-CD95-L
levels of s-CD95-L (ELISA test)

Locations

Country Name City State
France CHU Bordeaux Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary levels of s-CD95-L levels of s-CD95-L (ELISA test) in sera of non-infectious uveitis patients Baseline
Secondary Correlation between levels of s-CD95-L and Disease activity score Correlation between levels of s-CD95-L and Disease activity score (as defined by ophthalmologic examination) Baseline, Month 3
Secondary Th17 dosage Th17 dosage Baseline, Month 3
Secondary polynuclear neutrophils levels polynuclear neutrophils levels (Flow cytometry) Baseline, Month 3