Clinical trial NCT05928754: Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS
Official title: Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-infectious Uveitis
Keywords: non-infectious uveitis
Lead sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Sponsor class: OTHER
Collaborators: name: Groupe Hospitalier Pitie-Salpetriere
First posted: 2023-07-03
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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;

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.

Primary outcomes:
measure: Imaging database development
timeFrame: 60 months
measure: Biological constitution
timeFrame: 60 months
measure: medico economic costs estimation
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: