UveitisNCT06273748
RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age
An observational study of Uveitis, run by Meyer Children's Hospital IRCCS at 19 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Uveitis
- How many people
- 290 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 10 Feb 2022to 2 May 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- diagnosis of non-infectious chronic uveitis before the age of 16;
- signed informed consent form.
Who cannot join
- Patients with a diagnosis of infectious uveitis
- history of malignant pathology,
- history of demyelinating pathology,
- history of cerebral vasculitis
Trial locations and contacts
19 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 5 countries
Italy13 sites, 13 recruiting
- Not yet recruiting
Department of Pediatrics, Giovanni XXIII Pediatric Hospital, University of Bari
Bari
Francesco Latorre
- Not yet recruiting
Ospedale Spedali Civili di Brescia
Brescia
Marco Cattalini
- Recruiting
Department of Medical of Health Sciences, Magna Grecia University
Catanzaro
Romina Galizzi
- Recruiting
Meyer Children's Hospital IRCCS
Florence, Firenze
Gabriele Simonini, gabriele.simonini@meyer.it
- Recruiting
Dipartimento di Immunologia e Reumatologia Pediatrica, Ospedale Vito Fazzi
Lecce
Federico Diomeda
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico SC Pediatria e Immunoreumatologia PI
Milan
Francesca Minoia
- Not yet recruiting
Unità di Reumatologia ed Immunologia Pediatrica dell'Ospedale Fatebenefratelli Sacco di Milano
Milan
Angela Mauro
- Not yet recruiting
- UOSD Reumatologia Pediatrica Dipartimento di Salute della Donna e del Bambino Azienda Ospedale Università di Padova
Padova
Francesca Tirelli
- Not yet recruiting
Clinica Pediatrica, IRCCS Policlinico San Matteo
Pavia
- Not yet recruiting
IRCCS Ospedale Pediatrico Bambino Gesù Dipartimento Reumatologia
Roma
Silvia Magni Manzoni
- Not yet recruiting
Santa Maria Goretti Hospital
Roma
Emanuela Del Giudice
- Not yet recruiting
Unità di Immunologia e Reumatologia, Ospedale Pediatrico Regina Margherita, AOU Città della Salute e della scienza di Torino
Torino
Davide Montin
- Recruiting
IRCCS materno infantile Burlo Garofolo
Trieste
Serena Pastore
United States3 sites, 3 recruiting
- Recruiting
The Children's Hospital Corporation d/b/a Boston Children's Hospital
Boston, Massachusetts, 02115
Margaret Chang
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45207
Sheila Angels-Han
- Recruiting
Children's Mercy Kansas City Division of Rheumatology, Division of Rheumatology
Kansas City, Kansas, 64108
Ashley M Cooper
Belgium1 site, 1 recruiting
- Not yet recruiting
University fo Gent
Ghent
Joke Dehoorne
Greece1 site, 1 recruiting
- Recruiting
ATTIKON General Hospital
Athens, 12462
Lampros Fotis
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Department of Pediatric Rheumatology, Kocaeli University,
Kocaeli
Hafize Emine Sönmez
About this study
Official title: 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
- Conditions
- Uveitis
- Medical subject headings
- Uveitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: thorugh the study and after 1 year
Time to archieve the response after drug initiation
Time to archieve the response after drug initiation
Measured: 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
Measured: 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
Measured: 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
Measured: thorugh the study and after 1 year
Time to the first flare on therapy
Time to the first flare on therapy
Measured: 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
Measured: 6, 12 and 18 months, 2 years then every year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start10 Feb 2022
- Primary completion1 Feb 2032 (estimated)
- Study completion2 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Simonini, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273748
- Sponsor's protocol ID
- RChildUV
- Status last verified
- Sep 2025
- First submitted
- 14 Feb 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Observational Study on Non-infectious Chronic Uveitis in Pediatric Age
- ClinicalTrials.gov ID
- NCT06273748
- Acronym / sponsor ID
- RChildUV
- Conditions
- Uveitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 1 Feb 2032 (estimated)
- Study completion
- 2 May 2032 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- diagnosis of non-infectious chronic uveitis before the age of 16;
- signed informed consent form.
Key exclusion criteria (4 listed)
- Patients with a diagnosis of infectious uveitis
- history of malignant pathology,
- history of demyelinating pathology,
- history of cerebral vasculitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe a population of paediatric patients with chronic non-infectious uveitis
Time frame: thorugh 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
Describe a population of paediatric patients with chronic non-infectious uveitis
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: thorugh the study and after 1 year
Time to archieve the response after drug initiation
Achievement of inactive disease on therapy according to the definition of MIWGUC
Time frame: thorugh the study and after 1 year
Achievement of inactive disease on therapy according to the definition of MIWGUC
Time to achieve inactive disease on therapy according to the definition of MIWGUC
Time frame: thorugh the study and after 1 year
Time to achieve inactive disease on therapy according to the definition of MIWGUC
Presence and percentages of flares on therapy after achievement of remission on therapy
Time frame: thorugh the study and after 1 year
Presence and percentages of flares on therapy after achievement of remission on therapy
Time to the first flare on therapy
Time frame: thorugh the study and after 1 year
Time to the first flare on therapy
Time to flare after drug withdrawal
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis, run by Meyer Children's Hospital IRCCS at 19 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy, United States, Belgium, Greece, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Simonini (3297973141, gabriele.simonini@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe a population of paediatric patients with chronic non-infectious uveitis (time frame: thorugh the study and after 1 year). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.