Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS (CHRONOS)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Status: Not yet enrolling

Conditions: Non-infectious Uveitis

Treatments: Diagnostic Test: care strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT05928754

P22-01

Details and patient eligibility

About

prospective, cohort, longitudinal, multicenter, non-randomized study of patients with non-infectious posterior segment uveitis or panuveitis, with a group of control patients (scheduled for cataract or vitreoretinal surgery) and constitution of biological collection.

Full description

Description of the clinical characteristics and evolution in a large cohort of patients with non-infectious uveitis, allowing to identify prognostic or predictive factors of response after treatment of these different forms of non-infectious uveitis of the posterior segment or panuveitis (factors that are currently not well known).

Uveitis patients:

• Blood sample (20ml): Additional 20 ml blood sample during the first visit and potentially during follow-up (if necessary) for the purpose of the biological collection;
• Ocular sample (aqueous humor, vitreous): if required by the clinical context for the needs of the biological collection;
• Specific imaging: adaptive optics or Doppler holography, these procedures will be indicated on a case-by-case basis, at the investigator's discretion, and concern only patients with inflammatory vascular damage (5 to 10% of patients in the uveitis cohort);
• Quality of Life NEI-VFQ 25: provided at the inclusion visit and at follow-up visits M3-V2, M12-V5 and M24-V7.

Control patients:

• Blood sample (20ml): Additional 20 ml blood sample during the inclusion visit at the time of the surgical scheduled procedure for the needs of the biological collection;
• Ocular sample (aqueous humor, vitreous): considered as surgical waste, the tissue residues will be collected during the scheduled surgical procedure for cataract or vitreoretinal surgery for the needs of the biological collection;

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

UVEITIS Patients:

• Adult patients (≥ 18 years);

• Non-infectious uveitis;

• Intermediate, posterior or panuveitis;

• Inflammatory activity requiring treatment with either one or more of the followings:

  • Systemic corticosteroids or periocular or intravitreal injections of corticosteroids;
  • Immunosuppressants: methotrexate, azathioprine, cyclosporine, etc.;
  • Biotherapy: infliximab, adalimumab, tocilizumab;

• Patients with health insurance;

• Written Informed consent obtained at enrolment in the study.

Control patients:

• Adult patients (≥ 18 years);
• Scheduled patients ( Non-urgente procedure) for cataract or vitreoretinal surgery;
• Patients with health insurance;
• Written Informed consent obtained at enrolment in the study.

Exclusion criteria

Uveitis Patients:

• Isolated anterior uveitis ;

• Inactive disease defined as:

  • Absence of inflammatory chorioretinal and/or inflammatory retinal vascular lesion;
  • Anterior chamber cell grade< 0.5+;
  • Vitreous haze grade <0.5+;

• Pregnant or breastfeeding woman at the inclusion visit;

• Patient under legal protection (" curatelle " or " tutelle ");

• Patient denied freedom by a legal or administrative order.

Control patients:

• Pregnant or breastfeeding woman;
• Unscheduled (urgent) cataract or vitreoretinal surgery;
• Patient under legal protection (" curatelle " or " tutelle ");
• Patient denied freedom by a legal or administrative order.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Uveitis Patients

Experimental group

Description:

Uveitis Patients: intermediate, posterior or panuveitis noninfectious uveitis with Inflammatory activity requiring treatment with either one or more of the following: 1. Systemic corticosteroids or periocular or intravitreal injections of corticosteroids 2. Immunosuppressants: methotrexate, azathioprine, ciclosporine.... 3. Biotherapy: infliximab, adalimumab, tocilizumab

Treatment:

Diagnostic Test: care strategy

Control Patients

Active Comparator group

Description:

scheduled for cataract or vitreoretinal surgery

Treatment:

Diagnostic Test: care strategy