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

NCT06273748 | Recruiting

• 1 other identifier: RChildUV
• Study Type: observational
• Target: 290
• Locations: 5 countries
• Sites: 19

Brief 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

Conditions

Uveitis

Outcome Measures

Primary Outcomes (11)

• 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

  thorugh the study and after 1 year

• 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)

  6 months, 12 months, 2 years and then every year

• 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

  thorugh the study and after 1 year

• Identify risk factors for a more severe course

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

  thorugh the study and after 1 year

• 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

  thorugh the study and after 1 year

• Time to archieve the response after drug initiation

  Time to archieve the response after drug initiation

  thorugh the study and after 1 year

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

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

  thorugh the study and after 1 year

• 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

  thorugh the study and after 1 year

• 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

  thorugh the study and after 1 year

• Time to the first flare on therapy

  Time to the first flare on therapy

  thorugh the study and after 1 year

• 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

  6, 12 and 18 months, 2 years then every year

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (19)

Children's Mercy Kansas City Division of Rheumatology, Division of Rheumatology

Kansas City, Kansas, 64108, United States

RECRUITING

The Children's Hospital Corporation d/b/a Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45207, United States

RECRUITING

University fo Gent

Ghent, Belgium

NOT YET RECRUITING

ATTIKON General Hospital

Athens, 12462, Greece

RECRUITING

Meyer Children's Hospital IRCCS

Florence, Firenze, Italy

RECRUITING

Department of Pediatrics, Giovanni XXIII Pediatric Hospital, University of Bari

Bari, Italy

NOT YET RECRUITING

Ospedale Spedali Civili di Brescia

Brescia, Italy

NOT YET RECRUITING

Department of Medical of Health Sciences, Magna Grecia University

Catanzaro, Italy

RECRUITING

Dipartimento di Immunologia e Reumatologia Pediatrica, Ospedale Vito Fazzi

Lecce, Italy

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico SC Pediatria e Immunoreumatologia PI

Milan, Italy

RECRUITING

Unità di Reumatologia ed Immunologia Pediatrica dell'Ospedale Fatebenefratelli Sacco di Milano

Milan, Italy

NOT YET RECRUITING

- UOSD Reumatologia Pediatrica Dipartimento di Salute della Donna e del Bambino Azienda Ospedale Università di Padova

Padua, Italy

NOT YET RECRUITING

Clinica Pediatrica, IRCCS Policlinico San Matteo

Pavia, Italy

NOT YET RECRUITING

IRCCS Ospedale Pediatrico Bambino Gesù Dipartimento Reumatologia

Roma, Italy

NOT YET RECRUITING

Santa Maria Goretti Hospital

Roma, Italy

NOT YET RECRUITING

Unità di Immunologia e Reumatologia, Ospedale Pediatrico Regina Margherita, AOU Città della Salute e della scienza di Torino

Torino, Italy

NOT YET RECRUITING

IRCCS materno infantile Burlo Garofolo

Trieste, Italy

RECRUITING

Department of Pediatric Rheumatology, Kocaeli University,

Kocaeli, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Central Study Contacts

Gabriele Simonini

CONTACT

3297973141; gabriele.simonini@meyer.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rheumatology

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 23, 2024
• Study Start: February 10, 2022
• Primary Completion (Estimated): February 1, 2032
• Study Completion (Estimated): May 2, 2032
• Last Updated: March 27, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1); BE (1); GR (1); US (3); IT (13)