Long-term Safety of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis (EYEGUARD-X)
- Conditions
- Chronic Uveitis
- Interventions
- Biological: Gevokizumab
- Registration Number
- NCT02375685
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 71
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gevokizumab Gevokizumab -
- Primary Outcome Measures
Name Time Method Safety endpoints (adverse events, ...) 108 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Medical Competence
🇦🇹Wien, Austria
CHU-Hôtel Dieu
🇫🇷Nantes, France
Lions Eye Institute
🇦🇺Nedlands, Australia
Universitätsklinikum
🇩🇪Tübingen, Germany
Interbalkan Medical Center
🇬🇷Thessaloníki, Greece
Ospedale San Raffaele
🇮🇹Milano, Italy
Severance Hospital
🇰🇷Seoul, Korea, Republic of
ICOF ( Institut Clinic d'Oftalmologia )
🇪🇸Barcelona, Spain
AIBILI
🇵🇹Coimbra, Portugal
Chang Gung Memorial Hospital-Linkou
🇨🇳Taoyuan, Taiwan
Istanbul University
🇹🇷Istanbul, Turkey
Fattouma Bourguiba University hospital
🇹🇳Monastir, Tunisia
Moorfields Eye Hospital NHS Foundation Trust
🇬🇧London, United Kingdom