Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS

Not Applicable

Not yet recruiting

• Conditions: Non-infectious Uveitis
• Interventions: Diagnostic Test: care strategy

• Registration Number: NCT05928754
• Lead Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Brief Summary

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.

Detailed 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;

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-06-26
• Last Update Submitted: 2023-06-26
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03
• Study Start: 2023-09
• Primary Completion: 2028-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Patients	care strategy	scheduled for cataract or vitreoretinal surgery
Uveitis Patients	care strategy	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

Primary Outcome Measures

Name	Time	Method
Imaging database development	60 months	To develop an imaging database of Non-Infectious Uveitis of the posterior segment (NIUPS) using multimodal imaging
Biological constitution	60 months	To Constitute a biological collection of ocular and blood samples of NIUPS patients and controls
medico economic costs estimation	60 months	To estimate the current costs of treatment by ensuring linkage of cohort patients to the national claims database