Safety and Tolerability of Single Ascending Doses and Multiple Repeat Doses of OCU-10-C-110 for Injection in Study Participants With Neovascular Age-related Macular Degeneration (nAMD)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Ocular safety - AE
研究概览
简要总结
Multi-center, open-label, two-part safety assessment following administration of single ascending doses and repeat administration of the HTD of OCU-10-C-110 for Injection in the study eye of participants with nAMD
详细描述
In Part A, subjects will receive a single intravitreal dose in a single eye of the drug product. Dose will be escalated in 3 successive cohorts, pending safety. In Part B, subjects will receive 3 treatments in a single eye of drug product at 4 week intervals of the maximally tolerated dose, with an additional 4 weeks of observation for safety. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Angiographically documented active choroidal neovascular (CNV) lesion (i.e., leakage on fluorescein angiography or subretinal, intraretinal, or sub-retinal pigment epithelium [sub-RPE] fluid on spectral domain optical coherence tomography [SD-OCT]) secondary to age-related macular degeneration (AMD), within the previous 10 weeks
- •Subjects must have received, 7 to 14 days prior to the Baseline Visit, an intravitreal injection in the study eye of an anti-vascular endothelial growth factor (VEGF) ocular therapeutic approved for use in the United States
排除标准
- •History or current evidence of a medical condition (systemic or ophthalmic disease, metabolic dysfunction, physical examination finding or clinical laboratory finding) that may, in the opinion of the investigator, preclude the safe administration of the study medication, adherence to the scheduled study visits, or safe participation in the study or affect the results of the study (e.g., unstable or progressive cardiovascular, cerebral vascular, pulmonary, Parkinson's, liver or renal disease, depression, cancer, or dementia)
- •History or evidence of the following surgeries/procedures in the study eye:
- •Submacular surgery
- •Retinal detachment or retinal tear
- •Incisional glaucoma surgery
研究组 & 干预措施
Cohort A - Dose 1
干预措施: OCU-10-C-110 for Injection (Drug)
Cohort A - Dose 2
干预措施: OCU-10-C-110 for Injection (Drug)
Cohort A - Dose 3
干预措施: OCU-10-C-110 for Injection (Drug)
Cohort B - Dose TBD
干预措施: OCU-10-C-110 for Injection (Drug)
结局指标
主要结局
Ocular safety - AE
时间窗: Cohort A - 8 weeks; Cohort B - 12 weeks
Number of Adverse events
次要结局
- Systemic safety - AE(Cohort A - 8 weeks; Cohort B - 12 weeks)