A Multicenter, Dose-escalation and Dose-expansion, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy Characteristics of SCT520FF in Patients With Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Treatment emergent adverse events(TEAE)
研究概览
简要总结
Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form.
- •Age≥45 years, ≤80 years，male or femal.
- •The study eye must meet the following criteria: Diagnosis of nAMD;Active MNV lesions secondary to nAMD; Total area of all types of lesions ≤12 optic disc areas; BCVA of the study eye 73~19 letters.
排除标准
- •Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis, atrophy or dense subfoveal exudation involving the fovea in the study eye.
- •Significant APD or opacity of the refractive medium and miosis in the study eye that affect visual acuity or fundus examination.
- •Aphakia (except intraocular lens) or posterior capsular rupture of the lens in the study eye.
- •The study eye has any eye diseases or medical history other than nAMD that may affect central vision and/or macular examine.
- •MNV caused by non-nAMD exists in the study eye .
- •Active inflammation or infection in either eye before randomization.
- •Known allergy to any component of the study intervention or history of allergy to fluorescein or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study.
- •Abnormal liver and kidney function.
- •Poorly-controlled blood pressure before randomization.
- •History of a cardiovascular and cerebrovascular events, including myocardial infarction, unstable angina pectoris, cerebrovascular accidents (including TIA), other thromboembolic diseases (such as thromboembolic angiitis, etc) within 6 months before randomization.
- •Evidence of significant uncontrolled concomitant diseases.
- •Participated in any drug (other than vitamins and minerals) or device clinical trials within 3 months or the duration of 5 half-lives of the study drug (which is longer) before randomization and have used the test drug or received device treatment.
- •Pregnant, lactating women who can not take contraceptive measures during the trial.
研究组 & 干预措施
SCT520FF dose level 2 treatment
SCT520FF dose level 2(1.25mg),IVI,injection once every 4 weeks,three times continuously
干预措施: SCT520FF (Drug)
SCT520FF dose level 3 treatment
SCT520FF dose level 3(2.5mg),IVI,injection once every 4 weeks,three times continuously
干预措施: SCT520FF (Drug)
eylea 2 mg
eylea 2 mg,IVI,injection once every 4 weeks,during the study period
干预措施: EYLEA 2 MG (Drug)
SCT520FF dose level 1 treatment
SCT520FF dose level 1(0.625mg),IVI,injection once every 4 weeks,three times continuously
干预措施: SCT520FF (Drug)
结局指标
主要结局
Treatment emergent adverse events(TEAE)
时间窗: From Day 0 up to 196days
Incidence of treatment emergent adverse events
Treatment-related treatment emergent adverse events(TRAE)
时间窗: From Day 0 up to 196days
Incidence of treatment-related treatment emergent adverse events
Serious adverse event(SAE)
时间窗: From Day 0 up to 196days
Incidence of serious adverse event
Adverse event of special interest(AESI)
时间窗: From Day 0 up to 196days
Incidence of adverse event of special interest
Dose limited toxicity(DLT)
时间窗: From Day 0 up to 196days
Incidence of dose-limiting toxicities
次要结局
- Best corrected visual acuity(BCVA)(Day 0 up to 196 days)
- central retina thickness(CRT)(Day 0 up to 196days)
- PK profile(Day 0 up to 196days)
- Cmax(Day 0 up to 196days)
- Tmax(Day 0 up to 196days)
- PD profile(Day 0 up to 196 days)
- Immunogenicity(Day 0 up to 196days)