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Not yet recruitingNCT05928754CHRONOSUpdated Jul 3, 2023

Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS

An interventional study of care strategy in Non-infectious Uveitis, sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-03.

Sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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;
02

Conditions studied

  • Non-infectious Uveitis

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Keywords

  • non-infectious uveitis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Study arms

  • Experimental
    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

    Diagnostic Test: care strategy

  • Active comparator
    Control Patients

    scheduled for cataract or vitreoretinal surgery

    Diagnostic Test: care strategy

Interventions

  • Diagnostic testcare 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.

05

What researchers measure

Primary outcomes

  1. Imaging database development

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

    Time frame: 60 months

  2. Biological constitution

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

    Time frame: 60 months

  3. medico economic costs estimation

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

    Time frame: 60 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05928754
Lead sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Collaborators
Groupe Hospitalier Pitie-Salpetriere
Responsible party
Sponsor
First posted
Jul 3, 2023
Start date
Sep 2023 (estimated)
Primary completion
Aug 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Jul 3, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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