Soluble CD95 Ligand Role in the Pathophysiology of Non-infectious Active Uveitis

Completed

• Conditions: Non-Infectious Active Uveitis
• Interventions: Other: s-CD95-L

• Registration Number: NCT04354909
• Lead Sponsor: University Hospital, Bordeaux

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-21
• Study Start: 2020-11-17
• Primary Completion: 2023-03-10
• Study Completion: 2023-03-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biological samples	s-CD95-L	levels of s-CD95-L (ELISA test)

Primary Outcome Measures

Name	Time	Method
levels of s-CD95-L	Baseline	levels of s-CD95-L (ELISA test) in sera of non-infectious uveitis patients

Secondary Outcome Measures

Name	Time	Method
Correlation between levels of s-CD95-L and Disease activity score	Baseline, Month 3	Correlation between levels of s-CD95-L and Disease activity score (as defined by ophthalmologic examination)
Th17 dosage	Baseline, Month 3	Th17 dosage
polynuclear neutrophils levels	Baseline, Month 3	polynuclear neutrophils levels (Flow cytometry)

Trial Locations

Locations (1)

CHU Bordeaux; 🇫🇷 Bordeaux, France