Clinical trial NCT06273748: RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age
Official title: Retrospective and Prospective Observational Study on Non-infectious Chronic Uveitis in Pediatric Age
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uveitis
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 290
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: Describe a population of paediatric patients with chronic non-infectious uveitis
timeFrame: thorugh the study and after 1 year
measure: Describe a population of paediatric patients with chronic non-infectious uveitis
timeFrame: 6 months, 12 months, 2 years and then every year
measure: Identify any differences between the different forms of uveitis in terms of characteristics and outcomes
timeFrame: thorugh the study and after 1 year
measure: Identify risk factors for a more severe course
timeFrame: thorugh the study and after 1 year
measure: Frequency achievement of response for each drug according to the definition of response
timeFrame: thorugh the study and after 1 year
measure: Time to archieve the response after drug initiation
timeFrame: thorugh the study and after 1 year
measure: Achievement of inactive disease on therapy according to the definition of MIWGUC
timeFrame: thorugh the study and after 1 year
measure: Time to achieve inactive disease on therapy according to the definition of MIWGUC
timeFrame: thorugh the study and after 1 year
measure: Presence and percentages of flares on therapy after achievement of remission on therapy
timeFrame: thorugh the study and after 1 year
measure: Time to the first flare on therapy
timeFrame: thorugh the study and after 1 year
measure: Time to flare after drug withdrawal
timeFrame: 6, 12 and 18 months, 2 years then every year
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Athens
country: Greece
facility: - ATTIKON General Hospital
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
state: Firenze
city: Brescia
country: Italy
facility: Ospedale Spedali Civili di Brescia
city: Trieste
country: Italy
facility: IRCCS materno infantile Burlo Garofolo
Study officials:
References: