search
Back to results

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

Primary Purpose

Non-infectious Uveitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
care strategy
Sponsored by
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-infectious Uveitis focused on measuring non-infectious uveitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Uveitis Patients

    Control Patients

    Arm Description

    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

    scheduled for cataract or vitreoretinal surgery

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 26, 2023
    Last Updated
    June 26, 2023
    Sponsor
    Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
    Collaborators
    Groupe Hospitalier Pitie-Salpetriere
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05928754
    Brief Title
    Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS
    Acronym
    CHRONOS
    Official Title
    Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    August 2028 (Anticipated)
    Study Completion Date
    August 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
    Collaborators
    Groupe Hospitalier Pitie-Salpetriere

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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;

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-infectious Uveitis
    Keywords
    non-infectious uveitis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    2000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Uveitis Patients
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control Patients
    Arm Type
    Active Comparator
    Arm Description
    scheduled for cataract or vitreoretinal surgery
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    care strategy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Imaging database development
    Description
    To develop an imaging database of Non-Infectious Uveitis of the posterior segment (NIUPS) using multimodal imaging
    Time Frame
    60 months
    Title
    Biological constitution
    Description
    To Constitute a biological collection of ocular and blood samples of NIUPS patients and controls
    Time Frame
    60 months
    Title
    medico economic costs estimation
    Description
    To estimate the current costs of treatment by ensuring linkage of cohort patients to the national claims database
    Time Frame
    60 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS

    We'll reach out to this number within 24 hrs