EUCTR2012-001610-42-AT进行中（未招募）不适用
A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan- Uveitis - The EYEGUARD™-A study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
- •- Active uveitic disease, defined by the presence of = 2+ vitreous haze score in at least one eye
- •- Best Corrected Visual Acuity of at least 10 letters in the study eye
- •- Patients with a stable background treatment of oral corticosteroids, selected immunosuppressive therapy, or combination of both.
- •- 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:
- •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
排除标准
- •- Infectious uveitis and masquerade syndromes
- •- Isolated anterior uveitis
- •- Best corrected visual acuity < 35 letters in the non-study eye or monocular vision
- •- Presence of severe cataract or severe posterior capsular opacification.
- •- Contraindication to mydriatics or presence of posterior synechiae.
- •- 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
研究者
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