Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS

NCT05928754 | Not Yet Recruiting

• 1 other identifier: P22-01
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-infectious Uveitis

Keywords

non-infectious uveitis

Outcome Measures

Primary Outcomes (3)

• Imaging database development

  To develop an imaging database of Non-Infectious Uveitis of the posterior segment (NIUPS) using multimodal imaging

  60 months

• Biological constitution

  To Constitute a biological collection of ocular and blood samples of NIUPS patients and controls

  60 months

• medico economic costs estimation

  To estimate the current costs of treatment by ensuring linkage of cohort patients to the national claims database

  60 months

Study Arms (2)

Uveitis Patients

EXPERIMENTAL

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

Diagnostic Test: care strategy

Control Patients

ACTIVE COMPARATOR

scheduled for cataract or vitreoretinal surgery

Diagnostic Test: care strategy

Interventions

care strategy DIAGNOSTIC_TEST

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; Uveitis Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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+;
• 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.

Sponsors & Collaborators

• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts: lead
• Groupe Hospitalier Pitie-Salpetriere: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 3, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share