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Monitoring Drug-induced Uveitis

Monitoring Drug-induced Uveitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03899922
Acronym
UVETOX
Enrollment
1000
Registered
2019-04-02
Start date
2019-04-01
Completion date
2023-04-04
Last updated
2023-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Diseases, Uvea--Diseases, Uveitis, Uveitis Drug-Induced

Keywords

Uvea toxicity, chemotherapies, drugs

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.

Interventions

DRUGDrugs inducing uveitis

Drugs susceptible to induce uveitis

Sponsors

Groupe Hospitalier Pitie-Salpetriere
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Eye toxicities of drugs Identification and report of cases of uevitis associated with drugsto 01/04/2019Case reported in the World Health Organization (WHO) database of individual safety case reports

Secondary

MeasureTime frameDescription
All relevants statisticals associations between type of uveitis and the category of drugto 01/04/2019Case reported in the World Health Organization (WHO) database of individual safety case reports
All relevants statisticals associations between other concomittants immune related adverse events and uveitis induced by drugsto 01/04/2019Case reported in the World Health Organization (WHO) database of individual safety case reports
Duration of treatment when uveitis happen (role of cumulative dose)to 01/04/2019Case reported in the World Health Organization (WHO) database of individual safety case reports
Causality assessment of reported uveitis according to the WHO systemto 01/04/2019Case reported in the World Health Organization (WHO) database of individual safety case reports
All relevants statisticals associations between pathologies (cancer) for which the incriminated drugs have been prescribed, and occurence of uveitisto 01/04/2019Case reported in the World Health Organization (WHO) database of individual safety case reports
All relevants statisticals associations between characteristics of the population and occurence of uveitis adverse eventto 01/04/2019Case reported in the World Health Organization (WHO) database of individual safety case reports
All relevants statisticals associations between drug-drug interactions and adverse eventsto 01/04/2019Case reported in the World Health Organization (WHO) database of individual safety case reports

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026