Chronic Uveitis Clinical Trial
— EYEGUARD-XOfficial title:
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
| Verified date | January 2020 |
| Source | Servier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 71 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Lions Eye Institute | Nedlands | |
| Austria | Medical Competence | Wien | |
| France | CHU-Hôtel Dieu | Nantes | |
| Germany | Universitätsklinikum | Tübingen | |
| Greece | Interbalkan Medical Center | Thessaloníki | |
| Italy | Ospedale San Raffaele | Milano | |
| Korea, Republic of | Severance Hospital | Seoul | |
| Portugal | AIBILI | Coimbra | |
| Spain | ICOF ( Institut Clinic d'Oftalmologia ) | Barcelona | |
| Taiwan | Chang Gung Memorial Hospital-Linkou | Taoyuan | |
| Tunisia | Fattouma Bourguiba University hospital | Monastir | |
| Turkey | Istanbul University | Istanbul | |
| United Kingdom | Moorfields Eye Hospital NHS Foundation Trust | London |
| Lead Sponsor | Collaborator |
|---|---|
| Institut de Recherches Internationales Servier |
Australia, Austria, France, Germany, Greece, Italy, Korea, Republic of, Portugal, Spain, Taiwan, Tunisia, Turkey, United Kingdom,
Tugal-Tutkun I, Pavesio C, De Cordoue A, Bernard-Poenaru O, Gül A. Use of Gevokizumab in Patients with Behçet's Disease Uveitis: An International, Randomized, Double-Masked, Placebo-Controlled Study and Open-Label Extension Study. Ocul Immunol Inflamm. 20 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety endpoints (adverse events, ...) | 108 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00589628 -
Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis
|
Phase 4 |