An Open Label, Multi-Center, Safety Study of Intravitreal EBI-031, an Interleukin-6 (IL-6) Inhibitor, Administered as Single and Repeat Injections in Subjects With Diabetic Macular Edema (DME)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Safety, tolerability, and immunogenicity as measured by adverse events and anti-drug antibody development of single and repeat doses of EBI-031
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of up to 3 dose levels of EBI-031 given as an intravitreal injection in subjects with diabetic macular edema. There are two arms to the study, a single dose arm (1 dose) and a repeat dose arm (1 dose each month for 3 months). Eligible subjects will initially enroll in the single dose arm and 3 to 6 subjects will be dosed at each of the 3 dose levels. Safety will be assessed over the 28 days after the single dose prior to moving to the next higher dose level. Once all subjects in the single dose arm have been dosed with EBI-031 and the safety has been assessed eligible subjects will begin enrolling in the repeat dose arm. Subjects in the repeat dose arm will receive one dose each month for 3 months and will be assessed for safety. Escalation to the next higher dose will occur once it is determined safe to proceed to the next dose level. Six subjects will be dosed at each of the 3 dose levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Give written voluntary informed consent and any authorizations required by local law
- •Have a diagnosis of Type 1 or 2 diabetes mellitus
- •Have decreased vision determined primarily to be the result of DME in the study eye
- •Mean central foveal thickness on Spectral Domain Ocular Coherence Tomography (SD-OCT)> 325 in the study eye within 2 weeks of dosing
- •Have best corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score of <73 (~20/40) and >19 (~20/400) in the study eye within 2 weeks of dosing.
排除标准
- •Female that is pregnant and lactating
- •Any prior history of anti-interleukin 6 (anti-IL-6) treatment, for example: tocilizumab, sirukumab, sarilumab, olokizumab
- •Any concurrent biologics for immune disease such as anti-tumor necrosis factor (TNF): Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab); an anti-interleukin 12 (anti-IL-12): Stelara (ustekinumab); or an anti-interleukin 1 (anti-IL-1): Kineret (anakinra), Ilaris (canakinumab), Arcalyst (rilonacept).
- •Unstable, uncontrolled diabetes defined as hemoglobin A1C (HbA1C)≥10.5% within 3 months prior to dosing of EBI-031
- •Received intravitreal anti-vascular endothelial growth factor (anti-VEGF) such as Eylea (aflibercept) within 8 weeks, Lucentis (ranibizumab) and Avastin (bevacizumab) within 4 months prior to EBI-031
- •Significant renal disease, liver disease, or acute congestive heart failure
- •History of myocardial infarction (MI), stroke, or transient ischemic attack (TIA)
研究组 & 干预措施
Single dose arm
Subjects will receive a single intravitreal dose of EBI-031
干预措施: EBI-031 (Drug)
Repeat dose arm
Subjects will receive an intravitreal dose of EBI-031 monthly for 3 months
干预措施: EBI-031 (Drug)
结局指标
主要结局
Safety, tolerability, and immunogenicity as measured by adverse events and anti-drug antibody development of single and repeat doses of EBI-031
时间窗: Measure over the 84 days
Number of Participants With Abnormal Laboratory Values, Adverse Events, and/or antibodies to EBI-031
次要结局
未报告次要终点