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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-infectious Uveitis
• Intervention / Treatment: Diagnostic test: care strategy

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 Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Uveitis Patients; Uveitis Patients: intermediate, posterior or panuveitis noninfectious uveitis with Inflammatory activity requiring treatment with either one or more of the following: Systemic corticosteroids or periocular or intravitreal injections of corticosteroids; Immunosuppressants: methotrexate, azathioprine, ciclosporine….; Biotherapy: infliximab, adalimumab, tocilizumab	Diagnostic test: 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.
Active Comparator: Control Patients; scheduled for cataract or vitreoretinal surgery	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
• Collaborators: Groupe Hospitalier Pitie-Salpetriere

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: non-infectious uveitis
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis; Panuveitis
• Other Study ID Numbers: P22-01

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