NCT03666923已完成1 期
A Phase 1, Open-label, Multicenter, Dose Escalation Study to Evaluate the Safety of a Single Intravitreal Injection of THR-687 for the Treatment of Diabetic Macular Edema (DME)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 7
- 主要终点
- Incidence of dose-limiting toxicities up to the Day 14 visit
研究概览
简要总结
This study is conducted to evaluate the safety of a single intravitreal injection of THR-687.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Male or female aged 18 years or older
- •Type 1 or type 2 Diabetes Mellitus
- •Central-involved DME with central subfield thickness of ≥ 320µm on Spectralis® spectral domain optical coherence tomography (SD-OCT) or ≥ 305µm on non-Spectralis SD-OCT, in the study eye
- •Best-corrected visual acuity (BCVA) ≤ 62 and ≥ 23 ETDRS letter score in the study eye
- •Written informed consent obtained from the subject prior to screening procedures
排除标准
- •Macular edema due to causes other than DME
- •Concurrent disease in the study eye, other than central-involved DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
- •Any condition that could confound the ability to detect a change in central subfield thickness in the study eye
- •Previous confounding treatments / procedures, or expected to require confounding treatments / procedures at any time during the study period
- •Presence of neovascularization at the disc (NVD) in the study eye
- •Uncontrolled glaucoma in the study eye
- •Any active ocular / intra-ocular infection or inflammation in either eye
- •Poorly controlled Diabetes Mellitus
- •Uncontrolled hypertension
研究组 & 干预措施
THR-687 dose level 1
Experimental
Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 1
干预措施: THR-687 dose level 1 (Drug)
THR-687 dose level 2
Experimental
Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 2
干预措施: THR-687 dose level 2 (Drug)
THR-687 dose level 3
Experimental
Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 3
干预措施: THR-687 dose level 3 (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities up to the Day 14 visit
时间窗: From Day 0 up to Day 14
次要结局
- Occurrence of laboratory abnormalities up to the end of the study(At Screening, Day 1, Day 7, Day 28 and Day 84)
- Incidence of systemic and ocular adverse events including serious adverse events up to the end of the study(From Day 0 up to Day 84)
研究者
研究点 (7)
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