A Phase I/IIa, Dose-escalation and Dose-extension Study to Evaluate the Safety and Efficacy of Single Subretinal Injection of RRG001 in Subjects With Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
A Phase I/IIa, Dose-escalation and Dose-expansion Study to Evaluate the Safety and Efficacy of Single Subretinal Injection of RRG001 in Subjects With Neovascular Age-related Macular Degeneration
详细描述
This study adopts a multicenter, single-arm, open-label phase I/IIa seamless study design and comprises two stages, i.e., phase I 3+3 dose escalation study and a phase IIa dose expansion study. Four dose groups are preset for the phase I dose escalation study; 3-6 subjects will be enrolled for each dose group, and it is planned to enroll 12-24 subjects. The phase IIa dose expansion study will be conducted successively at the doses after safety assessments of dose 2 and/or dose 3 in phase I are completed. Twelve subjects are expected to be enrolled for each dose group, with a total of 24 subjects will be enrolled overall. The sponsor will assess whether or not to adjust the dose(s) and sample size for the exploration study based on the results in the phase I exploration study.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects that are willing and able to follow study procedures.
- •Patinets ≥50 years old.
- •Clinically diagnosed with CNV secondary to nAMD.
- •BCVA of the study eye is ≥5 letters and ≤73 letters(Snellen 20/800~20/40), as well as that of the other eye ≥19 letters(Snellen 20/400).
- •Responding to anti-VEGF
排除标准
- •Presence of any other eye diseases other than nAMD in study eye that would affect the treatment or confusing the interpretation of the study results , as judged by the investigator.
- •CNV or macular edema in the study eye secondary to any causes other than AMD.
- •Uncontrolled glaucoma.
- •Uncontrolled hypertension despite medication.
- •Pregnant or lactating women or individuals with reproductive potential who are unwilling to take effective contraception during the study period.
研究组 & 干预措施
RRG001 Dose1
Frequency of administration: one time injection.
干预措施: RRG001 (Drug)
RRG001 Dose2
Frequency of administration: one time injection.
干预措施: RRG001 (Drug)
RRG001 Dose3
Frequency of administration: one time injection.
干预措施: RRG001 (Drug)
RRG001 Dose4
Frequency of administration: one time injection.
干预措施: RRG001 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: Week 52
incidence of AEs and SAEs
次要结局
- Efficacy after RRG001 injection(Week 52)