EUCTR2011-003254-90-GB进行中（未招募）1 期
A randomised, active-controlled, open-label, multiple-dose, proof-of-concept study of intravitreal LFG316 in patients with active non-infectious intermediate-, posterior-, or panuveitis requiring systemic immunosuppressive therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
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
入选标准
- •Male or female patients 18 years or older
- •Active NIU, in at least one eye, as defined below, in patients requiring intensification of systemic immunosuppressive therapy.
- •-Vitreous haze at least 1+ on the scale of Nussenblatt et al 1985, or
- •-Chorioretinal lesions due to uveitis (chorioretinal lesions due to infections will exclude the patient)
- •- Patients who present with a flare and who are at the time of the enrollment on systemic corticosteroid or non-steroidal immunosuppressants will have their therapy tapered or stopped, respectively, at the time of intravitreal LFG316 administration.
- •- Visual acuity (ETDRS method) of 20 letters (20/400 snellen equivalent) or better in the study eye
- •Female patients, must not be pregnant or lactating and must, unless post-menopausal, use effective contraception.
- •Ability to provide informed consent and comply with the protocol.
- •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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Uveitis so severe that, in the investigator's judgment, it is too risky to test an experimental drug
- •Bilateral uveitis for which, in the opinion of the investigator, systemic immunosuppressive therapy is required to manage the inflammation in the fellow eye; use of local therapy in the fellow eye is acceptable and not an explicit exclusion (see section 5.5.7 for acceptable concomitant treatments)
- •Uncontrolled glaucoma or ocular hypertension in either eye, defined as an intraocular pressure (IOP) >30 mmHg while on medication for the specific condition
- •Forms of uveitis that may spontaneously resolve such as multiple evanescent white dot syndrome (MEWDS).
- •In the opinion of the investigator, clinically significant abnormality in screening laboratory results or electrocardiogram
- •In the study eye, cataract that is expected to interfere with study conduct or require surgery during the study
- •History of infectious uveitis or endophthalmitis in either eye
- •History of retinal detachment
- •Patients taking corticosteroids or other systemic immunosuppressive medication for any other disease (e.g., asthma or other autoimmune disease) where the tapering of the immunosuppressant would not be safe because of the risk of exacerbation of the extra ocular disease
- •Any biologic immunosuppressive agent given via intravitreal, intravenous or subcutaneous route within 4-12 months of screening depending on the agent.
- •Any intraocular surgery, intravitreal injection, periocular injection, or laser photocoagulation to the study eye within 90 days prior to dosing.
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