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NCT Number: NCT06273748

RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age

Uveitis is an inflammatory disease of the uvea, one of the highly vascularized fundamental structures of the eye. It is a rare condition in children, with an incidence in the pediatric population ranging from 2% to 14% of all uveitis cases. The diagnosis and management of patients with uveitis rely on a multidisciplinary approach involving an ophthalmologist, a rheumatologist, and an infectious disease specialist to establish the correct diagnosis and assess the involvement of other organs. In Italy, there is no national or regional registry for non-infectious chronic uveitis as per the Prime Ministerial Decree (DPCM) of March 3, 2017 (Identification of surveillance systems and registries for mortality, tumors, and other diseases). However, many clinical centers adopt data recording systems to evaluate the quality of care and to study diseases and outcomes. The Universitary Hospital Meyer Institute Research Hospital (IRCCS) is a national referral center for managing these pediatric cases of non-infectious chronic uveitis, estimated to constitute 95% of all pediatric uveitis cases

Recruiting

Interested in participating?

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Key information

Conditions

Uveitis Eye Diseases Uveal Diseases

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University fo Gent, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of non-infectious chronic uveitis before the age of 16;
  • signed informed consent form.

Exclusion criteria

  • Patients with a diagnosis of infectious uveitis
  • history of malignant pathology,
  • history of demyelinating pathology,
  • history of cerebral vasculitis

Treatment and study plan

Primary outcomes

  1. Describe a population of paediatric patients with chronic non-infectious uveitis

    Time frame: thorugh the study and after 1 year

    • Frequency of each aetiology of uveitis
    • Frequency of signs and symptoms at onset of uveitis
    • Frequency of laboratory findings
    • Frequency of each anatomical subtype of uveitis

  2. Describe a population of paediatric patients with chronic non-infectious uveitis

    Time frame: 6 months, 12 months, 2 years and then every year

    • Frequency of complications at onset, 6 months, 12 months, 2 years, then every year
    • Frequency of impaired visual acuity (LogMAR0.4-1) and blindness (LogMAR>=1) at onset and at different time points (6 months, 12 months, 18 months, 2 years, then every year)

  3. Identify any differences between the different forms of uveitis in terms of characteristics and outcomes

    Time frame: thorugh the study and after 1 year

    • Frequency of complications and impaired visual acuity
    • Description of laboratory characteristics

  4. Identify risk factors for a more severe course

    Time frame: thorugh the study and after 1 year

    Percentages of children with impaired visual acuity

    • Percentages of children with ocular complications

  5. Frequency achievement of response for each drug according to the definition of response

    Time frame: thorugh the study and after 1 year

    Frequency achievement of response for each drug according to the definition of response of the MIWGUC group

  6. Time to archieve the response after drug initiation

    Time frame: thorugh the study and after 1 year

    Time to archieve the response after drug initiation

  7. Achievement of inactive disease on therapy according to the definition of MIWGUC

    Time frame: thorugh the study and after 1 year

    Achievement of inactive disease on therapy according to the definition of MIWGUC

  8. Time to achieve inactive disease on therapy according to the definition of MIWGUC

    Time frame: thorugh the study and after 1 year

    Time to achieve inactive disease on therapy according to the definition of MIWGUC

  9. Presence and percentages of flares on therapy after achievement of remission on therapy

    Time frame: thorugh the study and after 1 year

    Presence and percentages of flares on therapy after achievement of remission on therapy

  10. Time to the first flare on therapy

    Time frame: thorugh the study and after 1 year

    Time to the first flare on therapy

  11. Time to flare after drug withdrawal

    Time frame: 6, 12 and 18 months, 2 years then every year

    Time to flare after drug withdrawal

    • Proportion of Flare after drug withdrawal in general at the last available follow-up
    • Proportion of children who flared after drug withdrawal at 6, 12 and 18 months, 2 years then every year

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriele Simonini

CONTACT

[email protected]

3297973141

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

Retrospective and Prospective Observational Study on Non-infectious Chronic Uveitis in Pediatric Age

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Feb 23, 2024
Registry last updated
Mar 27, 2026

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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