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

Recruiting

• Conditions: Uveitis

• Registration Number: NCT06273748
• Lead Sponsor: Meyer Children's Hospital IRCCS

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-10
• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08
• Primary Completion: 2032-02-01
• Study Completion: 2032-05-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 290

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe a population of paediatric patients with chronic non-infectious uveitis	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)
Identify any differences between the different forms of uveitis in terms of characteristics and outcomes	thorugh the study and after 1 year	* Frequency of complications and impaired visual acuity; * Description of laboratory characteristics
Identify risk factors for a more severe course	thorugh the study and after 1 year	Percentages of children with impaired visual acuity; * Percentages of children with ocular complications
Frequency achievement of response for each drug according to the definition of response	thorugh the study and after 1 year	Frequency achievement of response for each drug according to the definition of response of the MIWGUC group
Time to archieve the response after drug initiation	thorugh the study and after 1 year	Time to archieve the response after drug initiation
Time to the first flare on therapy	thorugh the study and after 1 year	Time to the first flare on therapy
Achievement of inactive disease on therapy according to the definition of MIWGUC	thorugh the study and after 1 year	Achievement of inactive disease on therapy according to the definition of MIWGUC
Presence and percentages of flares on therapy after achievement of remission on therapy	thorugh the study and after 1 year	Presence and percentages of flares on therapy after achievement of remission on therapy
Time to achieve 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 flare after drug withdrawal	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

Trial Locations

Locations (5)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

- ATTIKON General Hospital; 🇬🇷 Athens, Greece

Meyer Children's Hospital IRCCS; 🇮🇹 Florence, Firenze, Italy

Ospedale Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

IRCCS materno infantile Burlo Garofolo; 🇮🇹 Trieste, Italy