A Phase 1 Open-Label, Dose Escalation Study of OTX-TKI for Intravitreal Use in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Incidence of treatment emergent adverse events for each subject
研究概览
简要总结
To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD).
详细描述
A multi-center, dose escalation, Phase 1, safety, tolerability and efficacy study to evaluate three dose groups of the OTX-TKI implant to treat subjects with a diagnosis of primary subfoveal neovascularization secondary to AMD.
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
- None
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are at least 50 years of age
- •Are eligible for standard therapy
- •Have active primary CNVM secondary to AMD, either newly diagnosed or previously treated with documented response to anti-VEGF therapy in the study eye [primary subfoveal CNV secondary to AMD including juxtafoveal lesions that affect the fovea] documented by FA and SD-OCT
- •Are female who is postmenopausal for at least 12 months prior to screening or surgically sterile; or male or female of childbearing potential willing to use two forms of adequate contraception
- •Are able and willing to comply with all study requirements and visits
排除标准
- •Have previous laser photocoagulation to the center of the fovea in the study eye
- •Have participated in any study involving an investigational drug either in the U.S. or outside the U.S. within the past 30 days
- •Are an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same
- •Have a presence of a disease other than CNVM due to AMD in the study eye that could affect vision or safety assessments
研究组 & 干预措施
Cohort 1 (Low Dose)
Subjects will receive a low dose of OTX-TKI
干预措施: OTX-TKI (Drug)
Cohort 2 (Middle Dose)
Subjects will receive a middle dose of OTX-TKI.
干预措施: OTX-TKI (Drug)
Cohort 3 (High Dose)
Subjects will receive a high dose of OTX-TKI.
干预措施: OTX-TKI (Drug)
Cohort 3 (Anti-VEGF)
Subjects will receive OTX-TKI plus a single anti-VEGF injection
干预措施: OTX-TKI (Drug)
Cohort 3 (Anti-VEGF)
Subjects will receive OTX-TKI plus a single anti-VEGF injection
干预措施: Anti-VEGF (Drug)
Cohort 4 (High Dose)
Subjects will receive a high dose of OTX-TKI.
干预措施: OTX-TKI (Drug)
Cohort 4 (Anti-VEGF)
Subjects will receive OTX-TKI plus a single anti-VEGF injection
干预措施: OTX-TKI (Drug)
Cohort 4 (Anti-VEGF)
Subjects will receive OTX-TKI plus a single anti-VEGF injection
干预措施: Anti-VEGF (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events for each subject
时间窗: 9 months
All adverse events from screening through end of study will be captured
次要结局
- Determine the Maximum Tolerated Dose of the OTX-TKI injection(9 months)