A randomizEd, double-masked, placebo-controlled study of the safetY and Efficacy of GevokizUmAb in the tReatment of subjects with noninfectious intermeDiate, posterior, or pan- uveitis currently controlled with systemic treatment. The EYEGUARD-C Study. - The EYEGUARD-C Study

XOMA0 个研究点目标入组 300 人开始时间: 2013年1月11日最近更新: 2016年4月11日

试验速览

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•- Diagnosis of non-infectious intermediate, posterior, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (SUN criteria) of intermediate, posterior, or pan- uveitis confirmed by documented medical history; - Controlled uveitic disease in both eyes, defined by no active inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber cell grade < or = 0.5+ according to SUN criteria, Vitrous Haze grade < or = 0.5+ according to the SUN/NEI Scoring for Vitrous Haze; - Best Corrected Visual Acuity of 35 letters or more in both eyes; - Patients with a stable dose of oral corticosteroids, alone or in combination with selected stable immunosuppressive therapy; - Male or female, age =18 (or legal age of majority in the country) at selection; - For subjects with reproductive potential, a willingness to use highly effective contraceptive measures.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 270
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- Infectious uveitis and masquerade syndromes ; - Isolated anterior uveitis; - Best corrected visual acuity < 35 letters in both eyes or monocular vision; - Presence of severe cataract or severe posterior capsular opacification; - Contraindication to mydriatics or presence of posterior synechiae, in either eye; - Active TB disease; - History of severe allergic or anaphylactic reactions to monoclonal antibodies; - History of malignancy within 5 years prior to Selection; - Infectious disease; - Known immunodeficiency; - Pregnancy, breastfeeding or possibility to become pregnant during the study.

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