NCT06708637已完成4 期
An Open-Label, Multi-Center, Single-Arm Study to Evaluate the Ocular Safety and Usability of FYB203 Pre-filled Syringe (PFS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Formycon AG
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence and occurrence of ocular and non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring after IVT injection
研究概览
简要总结
The objective of the study is to assess the ocular safety of the FYB203 pre-filled syringe in terms of preparation and administration by Retina Specialists in the clinical setting.
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
- •Study eye deemed to be indicated for aflibercept IVT injection therapy at the discretion of the Investigator.
- •Written and signed informed consent form (ICF) obtained before any study-related procedures.
- •Had a confirmed diagnosis in one or both eyes of neovascular (wet) AMD or macular edema following RVO or DME or DR.
- •Qualified for treatment with aflibercept according to the United States Prescribing Information.
- •Aged ≥18 years at the time of signing ICF.
- •If a subject was already on an aflibercept regimen, timing of study participation was correlated with the regimen.
- •Male study subject (if his female spouse/partner was of childbearing potential) must have confirmed that he was using two acceptable methods for contraception (one of which must be a barrier method) starting at signing ICF and throughout the clinical study period and for 3 months after IP administration. Male study subject must have agreed to inform his partner of participation in the study and the need to avoid pregnancy. Surgically sterilized and non sexually active male subjects did not require any additional use of contraception.
- •Male study subject agreed not to donate sperm starting from screening and throughout the clinical study period and for 3 months after IP administration.
- •Female study subject was categorized by at least one of the following:
- •Not a woman of childbearing potential as described in Appendix 3 of the study protocol prior to signing ICF, or
- •Surgically sterile or had undergone a hysterectomy as categorized in Appendix 3 of the study protocol at least 1 month prior to signing ICF, or
- •Was using a highly effective contraception. All females of childbearing potential were required to use highly effective contraception (as described in Appendix 3 of the study protocol) starting at signing ICF and throughout the clinical study period and for 3 months after IP administration.
- •Female study subject must not be lactating and must not be breastfeeding at screening until 3 months after IP administration.
- •Female study subject must not donate ova starting at signing ICF and throughout the clinical study period and for 3 months after IP administration.
排除标准
- •Had received IVT injection in the study eye within 3 months prior to Day 1 with any anti vascular endothelial growth factor therapy other than aflibercept products (ege.g., Eylea).
- •Intraocular corticosteroid administration in the study eye within 30 days prior to Day
- •Had fever or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non cutaneous) infection within 1 week prior to Day
- •History or evidence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection in the last month prior to signing ICF or had been in confirmed contact with SARS-CoV-2 positive subjects in the last 2 weeks before dosing.
研究组 & 干预措施
FYB203 2 mg (0.05 mL of 40 mg/mL)
Experimental
FYB203 provided in a pre-filled syringe (PFS), containing 2 mg of 40 mg/mL aflibercept in 0.05 mL for intravitreal (IVT) administration
干预措施: FYB203 2 mg (0.05 mL of 40 mg/mL) (Drug)
结局指标
主要结局
Incidence and occurrence of ocular and non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring after IVT injection
时间窗: 2 days
To assess the ocular safety of the FYB203 PFS in terms of preparation and administration by Retina Specialists.
次要结局
未报告次要终点
研究者
研究点 (1)
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