Long-term Safety of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis (EYEGUARD-X)
EYEGUARD-X
A Safety Open-label Study of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis Disease, an eXtension Study. The EYEGUARD-X Study
2 other identifiers
interventional
71
11 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2014
Shorter than P25 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedJanuary 3, 2020
January 1, 2020
1.3 years
February 16, 2015
January 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety endpoints (adverse events, ...)
108 weeks
Study Arms (1)
gevokizumab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Lions Eye Institute
Nedlands, 6009, Australia
Medical Competence
Vienna, 1030, Austria
CHU-Hôtel Dieu
Nantes, 44000, France
Universitätsklinikum
Tübingen, 72076, Germany
Interbalkan Medical Center
Thessaloniki, 57 001, Greece
Ospedale San Raffaele
Milan, 20132, Italy
AIBILI
Coimbra, 3000-548, Portugal
Severance Hospital
Seoul, 03722, South Korea
ICOF ( Institut Clinic d'Oftalmologia )
Barcelona, 08028, Spain
Chang Gung Memorial Hospital-Linkou
Taoyuan District, Taiwan
Fattouma Bourguiba University hospital
Monastir, 5000, Tunisia
Istanbul University
Istanbul, 34390, Turkey (Türkiye)
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD, United Kingdom
Related Publications (1)
Tugal-Tutkun I, Pavesio C, De Cordoue A, Bernard-Poenaru O, Gul A. Use of Gevokizumab in Patients with Behcet's Disease Uveitis: An International, Randomized, Double-Masked, Placebo-Controlled Study and Open-Label Extension Study. Ocul Immunol Inflamm. 2018;26(7):1023-1033. doi: 10.1080/09273948.2017.1421233. Epub 2018 Jan 25.
PMID: 29370572RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2015
First Posted
March 3, 2015
Study Start
August 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
January 3, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- 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.
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.