Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS

NCT ID: NCT05928754

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2028-08-31

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;

Conditions

Non-infectious Uveitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Uveitis Patients

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

Group Type: EXPERIMENTAL

care strategy

Intervention Type: 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

scheduled for cataract or vitreoretinal surgery

Group Type: ACTIVE_COMPARATOR

care strategy

Intervention Type: 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.

Interventions

care strategy

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role: collaborator

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P22-01

Identifier Type: -

Identifier Source: org_study_id