EUCTR2020-005174-94-NL进行中（未招募）1 期
A Phase 2, Randomized, Placebo-Controlled, Double-Masked Study to Assess Safety and Efficacy of Multiple Doses of IONIS-FB-LRX, an Antisense Inhibitor of Complement Factor B, in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 355
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
- •1. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal.
- •2. Vaccination against Neisseria meningitidis and Streptococcus pneumoniae received at least 2 weeks prior to first dose of investigational product
- •3. Well-demarcated geographic atrophy (GA) due to AMD
- •4. Best-corrected visual acuity (BCVA) letter score of 35 letters (approx. 20/200 Snellen equivalent) or better on the ETDRS chart
- •5. Must have clear ocular media and adequate pupillary dilation in the study eye to permit high-quality fundus imaging
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 330
排除标准
- •1.Clinically-significant abnormalities in medical history
- •2. A lack of full recovery from any infection for at least 14 days prior to the Study Drug administration
- •3. Chronic treatment with steroids, including topically or intravitreally administered
- •4. History or presence of diabetic retinopathy or diabetic macular edema (DME)
- •5. History or presence of a disease other than AMD that could affect vision or safety assessments
- •6. Prior treatment with another investigational drug, biological agent, or device
- •7. Other protocol-specified inclusion/exclusion criteria may apply
研究者
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