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Not yet recruiting NCT05928754

Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS

No phase Interventional Non-infectious Uveitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: care strategy.
Who it may be relevant to
Registry conditions: Non-infectious Uveitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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;

Interventions

  • 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 infl

Primary outcome measures

  • Imaging database development [Time frame: 60 months]
  • Biological constitution [Time frame: 60 months]
  • medico economic costs estimation [Time frame: 60 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05928754 · P22-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗