Monitoring Drug-induced Uveitis (UVETOX)

April 4, 2023 updated by: Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with a drug that could be reported in the WHO's pharmacovigilance database

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Drug: Drugs inducing uveitis
Drugs susceptible to induce uveitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
to 01/04/2019

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
to 01/04/2019
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
to 01/04/2019
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
to 01/04/2019
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
to 01/04/2019
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
to 01/04/2019
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
to 01/04/2019
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
to 01/04/2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 4, 2023

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIC1421-19-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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