Single-arm, Open Label, Multicenter Clinical Study to Evaluate the Handling and Safety of AVT06 Pre-filled Syringe (PFS) in Subjects With Chorioretinal Vascular Disease Followed by an Optional Extension Phase of AVT06 Pre-filled Syringe (PFS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Proportion of AVT06 injections successfully administered with PFS at Day 1 to demonstrate effective and safe handling of AVT06 PFS.
研究概览
简要总结
This is a single-arm, open label, multicenter clinical study to evaluate the handling and safety of AVT06 pre-filled syringe (PFS) in subjects with chorioretinal vascular disease followed by an optional extension phase of AVT06 pre-filled syringe (PFS)
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
- •Male or female ≥18 years old
- •Subjects with diagnosis of nAMD (wet), DME, RVO, DR, or myopic CNV in the study eye
- •Study eye considered by the Principal Investigator to be indicated for treatment with aflibercept
- •Subjects must sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form (ICF) before any study-specific procedures
- •Willing and able to comply with all study procedures and be likely to complete the study
- •Subjects must be able to follow the contraception requirements
排除标准
- •(selected):
- •Any concurrent ocular condition in the study eye which, in the opinion of the Principal Investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of IVT injections, or which otherwise may interfere with the injection procedure or with evaluation of safety
- •Current systemic infectious disease or a therapy for active infectious disease Any condition that, in the Principal Investigator's opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the subject, or interfere with interpretation of study data
研究组 & 干预措施
AVT06 (proposed aflibercept biosimilar) PFS
IVT injection with a PFS containing the proposed aflibercept biosimilar AVT06
干预措施: Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule (Device)
结局指标
主要结局
Proportion of AVT06 injections successfully administered with PFS at Day 1 to demonstrate effective and safe handling of AVT06 PFS.
时间窗: Day 1
Proportion of AVT06 injections successfully administered with PFS at Day 1
Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4 to evaluate ocular safety of AVT06 delivered from the PFS
时间窗: Week 4
Incidence of ocular TEAEs, AESIs, and SAEs on the study eye from Baseline to Week 4
次要结局
未报告次要终点