Phase 1, Open-Label Safety and Pharmacodynamic Study of RV001, an Insulin-Like Growth Factor-1 Receptor (IGF-1R) Antagonist, Administered by Intravenous (IV) Infusion in Patients With Diabetic Macular Edema (DME)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Safety of RV001in subjects with Diabetic Macular Edema
研究概览
简要总结
A Phase 1 Study to evaluate the Safety of teprotumumab in Patients with Diabetic Macular Edema.
详细描述
A Phase 1, Open-Label Safety and Pharmacodynamic Study of RV 001, an Insulin-Like Growth Factor-1 Receptor (IGF-1) Antagonist, Given By IV Infusion in Patients with Diabetic Macular Edema (DME).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of diabetes mellitus with Hemoglobin A1c <8.5%
- •IGF 1 in serum > 106 ng/mL
- •Women of child-bearing potential must have negative pregnancy test and be willing and able to use two different methods of contraception, one of which must be oral contraceptive or depot formulation. Males must be surgically sterile or agree to use barrier contraception
- •Clinically significant DME of less than 12 months duration
- •Non-proliferative diabetic retinopathy of moderate severity
- •Best corrected electronic ETDRS letter score < 78 and > 24
排除标准
- •Unstable-uncontrolled diabetes as demonstrated by a change in diabetes medication greater than 15% in the previous 60 days.
- •Significant renal disease, myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure
- •Blood pressure > 180/110
- •Anti-vascular endothelial growth factor (VEGF) treatment within two months prior to enrollment
- •History of pan retinal photocoagulation within four months prior to enrollment
- •History of ocular surgery within four months prior to enrollment
- •History of systemic treatment with corticosteroids within 3 months prior to enrollment
研究组 & 干预措施
Teprotumumab
Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions
干预措施: Teprotumumab (Drug)
结局指标
主要结局
Safety of RV001in subjects with Diabetic Macular Edema
时间窗: Change from Baseline to Week 9
Number of subjects with adverse events, serious adverse events and early discontinuations due to adverse events. Number of subjects with clinical significant abnormal laboratory values, electrocardiograms (pre and post infusions), abnormal vital signs, ophthalmic and physical examinations.
次要结局
- Safety of RV001in subjects with Diabetic Macular Edema(Change from Baseline to Week 9)