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NCT Number: NCT05928754

Prospective CoHoRt Of Non-infectious Intermediate, pOsterior or panuveitiS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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;

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

care strategy

Diagnostic Test

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.

Primary outcomes

  1. Imaging database development

    Time frame: 60 months

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

  2. Biological constitution

    Time frame: 60 months

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

  3. medico economic costs estimation

    Time frame: 60 months

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Other

Collaborators

  • Groupe Hospitalier Pitie-Salpetriere

Registry information

Acronym: CHRONOS

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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