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

Uveitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273748
• Other study ID #: RChildUV
• Status: Recruiting
• Start date: February 10, 2022
• Est. completion date: May 2, 2032

Study information

• Verified date: March 2024
• Source: Meyer Children's Hospital IRCCS
• Contact: Gabriele Simonini
• Phone: 3297973141
• Email: gabriele.simonini[@]meyer.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: May 2, 2032
• Est. primary completion date: February 1, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Uveitis

Locations

Country	Name	City	State
Greece	- ATTIKON General Hospital	Athens
Italy	Ospedale Spedali Civili di Brescia	Brescia
Italy	Meyer Children's Hospital IRCCS	Florence	Firenze
Italy	IRCCS materno infantile Burlo Garofolo	Trieste
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Meyer Children's Hospital IRCCS

Countries where clinical trial is conducted

United States,  Greece,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Time to archieve the response after drug initiation	Time to archieve the response after drug initiation	thorugh the study and after 1 year
Primary	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
Primary	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
Primary	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
Primary	Time to the first flare on therapy	Time to the first flare on therapy	thorugh the study and after 1 year
Primary	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