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

Retrospective and Prospective Observational 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

Study Overview

• Status: Recruiting
• Conditions: Uveitis

• Study Type: Observational
• Enrollment (Estimated): 290

Contacts and Locations

• Study Contact: Name: Gabriele Simonini; Phone Number: 3297973141; Email: gabriele.simonini@meyer.it

Study Locations

• Greece
  • Athens, Greece, 12462
    • Recruiting
    • - ATTIKON General Hospital
    • Contact: Lampros Fotis
• Italy
  • Brescia, Italy
    • Not yet recruiting
    • Ospedale Spedali Civili di Brescia
    • Contact: Marco Cattalini
  • Trieste, Italy
    • Recruiting
    • IRCCS Materno Infantile Burlo Garofolo
    • Contact: Serena Pastore
  • Firenze
    • Florence, Firenze, Italy
      • Recruiting
      • Meyer Children's Hospital IRCCS
      • Contact: Gabriele Simonini; Email: gabriele.simonini@meyer.it
• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45207
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Sheila Angels-Han

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Estimated): February 1, 2032
• Study Completion (Estimated): May 2, 2032

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis
• Other Study ID Numbers: RChildUV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No