Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS

Non-infectious Uveitis Clinical Trial

— CHRONOS  

Official title:

Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05928754
• Other study ID #: P22-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: August 2028

Study information

• Verified date: June 2023
• Source: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: August 2028
• Est. primary completion date: August 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Non-infectious Uveitis
• Panuveitis
• Uveitis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts	Groupe Hospitalier Pitie-Salpetriere

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging database development	To develop an imaging database of Non-Infectious Uveitis of the posterior segment (NIUPS) using multimodal imaging	60 months
Primary	Biological constitution	To Constitute a biological collection of ocular and blood samples of NIUPS patients and controls	60 months
Primary	medico economic costs estimation	To estimate the current costs of treatment by ensuring linkage of cohort patients to the national claims database	60 months