CHRONOS: Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Imaging database development [60 months]
To develop an imaging database of Non-Infectious Uveitis of the posterior segment (NIUPS) using multimodal imaging
- Biological constitution [60 months]
To Constitute a biological collection of ocular and blood samples of NIUPS patients and controls
- medico economic costs estimation [60 months]
To estimate the current costs of treatment by ensuring linkage of cohort patients to the national claims database
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Groupe Hospitalier Pitie-Salpetriere
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P22-01