Monitoring Drug-induced Uveitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Eye toxicities of drugs Identification and report of cases of uevitis associated with drugs
Study Overview
Brief Summary
Several drugs and chemotherapies seem to induce uveitis. This study investigates reports of uveitis, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).
Detailed Description
Several drugs and chemotherapies seem to have an impact on the eyes and are responsible of uveitis. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by uveitis side effect imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Case reported in the WHO's pharmacovigilance database till 01/04/2019
Exclusion Criteria
- •Chronology not compatible between the drug and the toxicity
Arms & Interventions
Uveitis induced by drugs and chemotherapies
Case reported in the World Health Organization (WHO) of uveitis of patient treated by a drug, with a chronology compatible with the drug toxicity
Intervention: Drugs inducing uveitis (Drug)
Outcomes
Primary Outcomes
Eye toxicities of drugs Identification and report of cases of uevitis associated with drugs
Time Frame: to 01/04/2019
Case reported in the World Health Organization (WHO) database of individual safety case reports
Secondary Outcomes
- Causality assessment of reported uveitis according to the WHO system(to 01/04/2019)
- Duration of treatment when uveitis happen (role of cumulative dose)(to 01/04/2019)
- All relevants statisticals associations between type of uveitis and the category of drug(to 01/04/2019)
- All relevants statisticals associations between other concomittants immune related adverse events and uveitis induced by drugs(to 01/04/2019)
- All relevants statisticals associations between drug-drug interactions and adverse events(to 01/04/2019)
- All relevants statisticals associations between pathologies (cancer) for which the incriminated drugs have been prescribed, and occurence of uveitis(to 01/04/2019)
- All relevants statisticals associations between characteristics of the population and occurence of uveitis adverse event(to 01/04/2019)
Investigators
Joe Elie Salem
Assistant director, clinical investigation center Paris Est
Groupe Hospitalier Pitie-Salpetriere