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RecruitingNCT06273748Updated Mar 27, 2026

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

An observational study in Uveitis, sponsored by Meyer Children's Hospital IRCCS. Recruiting at 19 sites in 5 countries. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Meyer Children's Hospital IRCCS · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
290
Ages
1 Year to 16 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Uveitis

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03

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The data of patients who have been under the care of the hospital since 2010 will be included, and new patients diagnosed from the date of Ethical Committee approval onwards for the next 10 years will also be included

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with a diagnosis of infectious uveitis
  • history of malignant pathology,
  • history of demyelinating pathology,
  • history of cerebral vasculitis
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
290 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

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

    * 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

    Time frame: thorugh the study and after 1 year

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

    * 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)

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

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

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

    Time frame: thorugh the study and after 1 year

  4. Identify risk factors for a more severe course

    Percentages of children with impaired visual acuity * Percentages of children with ocular complications

    Time frame: thorugh the study and after 1 year

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

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

    Time frame: thorugh the study and after 1 year

  6. Time to archieve the response after drug initiation

    Time to archieve the response after drug initiation

    Time frame: thorugh the study and after 1 year

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

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

    Time frame: thorugh the study and after 1 year

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

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

    Time frame: thorugh the study and after 1 year

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

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

    Time frame: thorugh the study and after 1 year

  10. Time to the first flare on therapy

    Time to the first flare on therapy

    Time frame: thorugh the study and after 1 year

  11. Time to flare after drug withdrawal

    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

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

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Study locations

10 of 19 sites recruiting
  • Children's Mercy Kansas City Division of Rheumatology, Division of Rheumatology
    Kansas City, Kansas 64108, United States
    • Ashley M Cooper · Contact
    Recruiting
  • The Children's Hospital Corporation d/b/a Boston Children's Hospital
    Boston, Massachusetts 02115, United States
    • Margaret Chang · Contact
    Recruiting
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45207, United States
    • Sheila Angels-Han · Contact
    Recruiting
  • University fo Gent
    Ghent, Belgium
    • Joke Dehoorne · Contact
    Not yet recruiting
  • ATTIKON General Hospital
    Athens, 12462, Greece
    • Lampros Fotis · Contact
    Recruiting
  • Meyer Children's Hospital IRCCS
    Florence, Firenze, Italy
    Recruiting
  • Department of Pediatrics, Giovanni XXIII Pediatric Hospital, University of Bari
    Bari, Italy
    • Francesco Latorre · Contact
    Not yet recruiting
  • Ospedale Spedali Civili di Brescia
    Brescia, Italy
    • Marco Cattalini · Contact
    Not yet recruiting
  • Department of Medical of Health Sciences, Magna Grecia University
    Catanzaro, Italy
    • Romina Galizzi · Contact
    Recruiting
  • Dipartimento di Immunologia e Reumatologia Pediatrica, Ospedale Vito Fazzi
    Lecce, Italy
    • Federico Diomeda · Contact
    Recruiting
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico SC Pediatria e Immunoreumatologia PI
    Milan, Italy
    • Francesca Minoia · Contact
    Recruiting
  • Unità di Reumatologia ed Immunologia Pediatrica dell'Ospedale Fatebenefratelli Sacco di Milano
    Milan, Italy
    • Angela Mauro · Contact
    Not yet recruiting
  • - UOSD Reumatologia Pediatrica Dipartimento di Salute della Donna e del Bambino Azienda Ospedale Università di Padova
    Padova, Italy
    • Francesca Tirelli · Contact
    Not yet recruiting
  • Clinica Pediatrica, IRCCS Policlinico San Matteo
    Pavia, Italy
    Not yet recruiting
  • IRCCS Ospedale Pediatrico Bambino Gesù Dipartimento Reumatologia
    Roma, Italy
    • Silvia Magni Manzoni · Contact
    Not yet recruiting
  • Santa Maria Goretti Hospital
    Roma, Italy
    • Emanuela Del Giudice · Contact
    Not yet recruiting
  • Unità di Immunologia e Reumatologia, Ospedale Pediatrico Regina Margherita, AOU Città della Salute e della scienza di Torino
    Torino, Italy
    • Davide Montin · Contact
    Not yet recruiting
  • IRCCS materno infantile Burlo Garofolo
    Trieste, Italy
    • Serena Pastore · Contact
    Recruiting
  • Department of Pediatric Rheumatology, Kocaeli University,
    Kocaeli, Turkey (Türkiye)
    • Hafize Emine Sönmez · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06273748
Lead sponsor
Meyer Children's Hospital IRCCS
Responsible party
Gabriele Simonini (Head of Rheumatology, Meyer Children's Hospital IRCCS) — Principal investigator
First posted
Feb 23, 2024
Start date
Feb 10, 2022
Primary completion
Feb 1, 2032 (estimated)
Completion
May 2, 2032 (estimated)
Last update
Mar 27, 2026

Study contacts

Gabriele Simonini
Contact
gabriele.simonini@meyer.it
3297973141

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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