Long-term Safety of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis (EYEGUARD-X) (EYEGUARD-X)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
either completed participation to one of the following: CL3-78989-002 open-label extension, or X052130/CL3-78989-005 double-masked period or open-label period, or X052131/CL3-78989-006 double-masked period or open-label period, or currently benefiting from gevokizumab compassionate use after participation in gevokizumab uveitis studies
Male or female, age ≥18 (or legal age of majority in the country) at selection.
For subject with reproductive potential, a willingness to use highly effective contraceptive measures
Meeting criteria for discontinuation of any of gevokizumab uveitis previous study.
Infectious uveitis and masquerade syndrome
History of severe allergic or anaphylactic reaction to study drug administration during previous study or to gevokizumab or any of its excipient.
Currently active infectious disease.
Other protocol-defined inclusion/exclusion criteria may apply
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).
They can ask all interventional clinical studies:
submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
After Marketing Authorisation in EEA or US if the study is used for the approval.
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
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