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

Condition(s) studied

Study 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

Primary outcome measure(s)

• Describe a population of paediatric patients with chronic non-infectious uveitis — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — thorugh the study and after 1 year
  Time to the first flare on therapy
• Time to flare after drug withdrawal — 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

Trial sites (19)

More Meyer Children's Hospital IRCCS trials in Italy

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