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Completed

NCT Number: NCT03899922

Monitoring Drug-induced Uveitis

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).

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Key information

Conditions

Uveitis Eye Diseases Uvea--Diseases Uveal Diseases Uveitis Drug-Induced

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drugs inducing uveitis

Drug

Drugs susceptible to induce uveitis

Primary outcomes

  1. 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

  1. Causality assessment of reported uveitis according to the WHO system

    Time frame: to 01/04/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

  2. All relevants statisticals associations between type of uveitis and the category of drug

    Time frame: to 01/04/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

  3. All relevants statisticals associations between other concomittants immune related adverse events and uveitis induced by drugs

    Time frame: to 01/04/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

  4. Duration of treatment when uveitis happen (role of cumulative dose)

    Time frame: to 01/04/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

  5. All relevants statisticals associations between drug-drug interactions and adverse events

    Time frame: to 01/04/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

  6. All relevants statisticals associations between pathologies (cancer) for which the incriminated drugs have been prescribed, and occurence of uveitis

    Time frame: to 01/04/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

  7. All relevants statisticals associations between characteristics of the population and occurence of uveitis adverse event

    Time frame: to 01/04/2019

    Case reported in the World Health Organization (WHO) database of individual safety case reports

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Acronym: UVETOX

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Apr 2, 2019
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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