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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06273748
Enrollment
290
Registered
2024-02-23
Start date
2022-02-10
Completion date
2032-05-02
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveitis

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

Interventions

None listed

Sponsors

Meyer Children's Hospital IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Describe a population of paediatric patients with chronic non-infectious uveitisthorugh the study and after 1 year* 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
Identify any differences between the different forms of uveitis in terms of characteristics and outcomesthorugh the study and after 1 year* Frequency of complications and impaired visual acuity * Description of laboratory characteristics
Identify risk factors for a more severe coursethorugh the study and after 1 yearPercentages of children with impaired visual acuity * Percentages of children with ocular complications
Frequency achievement of response for each drug according to the definition of responsethorugh the study and after 1 yearFrequency achievement of response for each drug according to the definition of response of the MIWGUC group
Time to archieve the response after drug initiationthorugh the study and after 1 yearTime to archieve the response after drug initiation
Achievement of inactive disease on therapy according to the definition of MIWGUCthorugh the study and after 1 yearAchievement of inactive disease on therapy according to the definition of MIWGUC
Time to achieve inactive disease on therapy according to the definition of MIWGUCthorugh the study and after 1 yearTime to achieve inactive disease on therapy according to the definition of MIWGUC
Presence and percentages of flares on therapy after achievement of remission on therapythorugh the study and after 1 yearPresence and percentages of flares on therapy after achievement of remission on therapy
Time to the first flare on therapythorugh the study and after 1 yearTime to the first flare on therapy
Time to flare after drug withdrawal6, 12 and 18 months, 2 years then every yearTime 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

Countries

Belgium, Greece, Italy, Turkey (Türkiye), United States

Contacts

CONTACTGabriele Simonini
gabriele.simonini@meyer.it3297973141

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026