Soluble CD95 Ligand Role in the Pathophysiology of Non-infectious Active Uveitis (UVE-FAS)

May 14, 2024 updated by: University Hospital, Bordeaux
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patients with non-infectious uveitis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Biological samples
levels of s-CD95-L (ELISA test)
Other: s-CD95-L
levels of s-CD95-L (ELISA test)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
levels of s-CD95-L
Time Frame: Baseline
levels of s-CD95-L (ELISA test) in sera of non-infectious uveitis patients
Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2020

Primary Completion (Actual)

March 10, 2023

Study Completion (Actual)

March 10, 2023

Study Registration Dates

First Submitted

March 16, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2019/43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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