Recruiting

Observational Study

Sponsor:

Meyer Children's Hospital IRCCS

Code:

NCT06273748

Conditions

Uveitis

Eligibility Criteria

Sex: All

Age: 1 - 16

Healthy Volunteers: Not accepted

Study Details

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

Conditions

Uveitis

Study ID

NCT06273748

Start date

Feb 10, 2022

Status verified date

Sep, 2025

Completion date

May 2, 2032

Anticipated

Primary completion date

Feb 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 16

Healthy Volunteers: Not accepted

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 Design

Enrollment

290 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Describe a population of paediatric patients with chronic non-infectious uveitis [ Time Frame: thorugh the study and after 1 year ]
  • Describe a population of paediatric patients with chronic non-infectious uveitis [ Time Frame: 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 [ Time Frame: thorugh the study and after 1 year ]
  • Identify risk factors for a more severe course [ Time Frame: thorugh the study and after 1 year ]
  • Frequency achievement of response for each drug according to the definition of response [ Time Frame: thorugh the study and after 1 year ]
  • Time to archieve the response after drug initiation [ Time Frame: thorugh the study and after 1 year ]
  • Achievement of 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 [ Time Frame: thorugh the study and after 1 year ]
  • Presence and percentages of flares on therapy after achievement of remission on therapy [ Time Frame: thorugh the study and after 1 year ]
  • Time to the first flare on therapy [ Time Frame: thorugh the study and after 1 year ]
  • Time to flare after drug withdrawal [ Time Frame: 6, 12 and 18 months, 2 years then every year ]

Central Contacts and Locations

Central contacts

Gabriele Simonini

3297973141gabriele.simonini@meyer.it

Locations

Children's Mercy Kansas City Division of Rheumatology, Division of Rheumatology

Recruiting

Kansas City, Kansas, United States, 64108

The Children's Hospital Corporation d/b/a Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45207

More Information

Sponsor

Meyer Children's Hospital IRCCS

Last update posted

Mar 27, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Meyer Children's Hospital IRCCS on 2026-03-27.