A 2-part Study Consisting of an Open-label Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Single-masked Comparative Safety and Preliminary Efficacy Study of Intravitreal (IVT) EYE103 in a Mixed Population of Participants With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 31
- 主要终点
- Adverse Events
研究概览
简要总结
EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.
In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study.
In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.
详细描述
EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.
In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study.
In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participant Care Provider Outcomes Assessor
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
- •Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
- •DME patients must be ≥ 18 years of age, NVAMD patients must be ≥ 50 years of age
- •Diagnosis of either DME or NVAMD. DME patients must be treatment naïve. NVAMD patients can be either treatment naïve or treatment experienced.
- •DME patients must have vision loss in the study eye
- •NVAMD patients can be either treatment-naïve or treatment experienced with vision loss in the study eye
排除标准
- •Be pregnant or breastfeeding
- •History of cataract surgery and/or minimally invasive glaucoma surgery (MIGS) within 3 months of Screening
- •Yttrium-Aluminum Garnet (YAG) laser capsulotomy within 2 months of Screening
- •Any other condition except for DME or NVAMD or that could affect interpretation of study assessments
研究组 & 干预措施
Dose 1
Part 1 MAD Portion Dose 1 - Low Dose
干预措施: EYE103 (Drug)
Dose 2
Part 1 MAD Portion Dose 2 - Low-Mid Dose
干预措施: EYE103 (Drug)
Dose 3
Part 1 MAD Portion Dose 3 - Mid-High Dose
干预措施: EYE103 (Drug)
Dose 4
Part 1 MAD Portion Dose 4 - High Dose
干预措施: EYE103 (Drug)
DME Medium Dose
Part 2 Naïve DME monotherapy Medium Dose
干预措施: EYE103 (Drug)
DME High Dose
Part 2 Naïve DME monotherapy High Dose
干预措施: EYE103 (Drug)
Naïve NVAMD Medium Dose
Part 2 Naïve NVAMD combination therapy Medium Dose
干预措施: EYE103 (Drug)
Naïve NVAMD High Dose
Part 2 Naïve NVAMD combination therapy High Dose
干预措施: EYE103 (Drug)
Experienced NVAMD Medium Dose
Part 2 Experienced NVAMD combination therapy Medium Dose
干预措施: EYE103 (Drug)
Experienced NVAMD High Dose
Part 2 Experienced NVAMD combination therapy High Dose
干预措施: EYE103 (Drug)
结局指标
主要结局
Adverse Events
时间窗: 3 months
Adverse Events
次要结局
- Best-corrected Visual Acuity(3 months)