A First-In-Human, Open-Label, Dose Escalating, Non-Randomized Study to Assess the Safety and Tolerability of a New Timolol Sustained Release Intraocular Implant (TimoD) in Subjects With Primary Open Angle Glaucoma With Pseudophakia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- EyeD Pharma
- 入组人数
- 1
- 试验地点
- 5
- 主要终点
- Number and proportion of participants experiencing one or more serious adverse events (SAEs)
研究概览
简要总结
The purpose of this study is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma and pseudophakia (currently present or to be performed during the concomitant implantation surgery in subjects with age-related cataract eligible to intra-capsular IOL placement). The main questions it aims to answer are how safe the investigational drug is and how the body tolerates it.
The study will also check:
- how safely the implant is placed in and removed from the eye and how the body responds to the procedure,
- how safe different doses of timolol are and how the body handles taking it,
- the amount of Timolol released in the bloodstream,
- if there is any positive effect on the pressure inside the eye.
详细描述
Timolol will be delivered through an investigational drug called 'TimoD implant'. This implant is placed inside one eye, the study eye, with the help of an instrument (investigational device) called an injector system.
Three dose ranges of TimoD implant will be tested (low, intermediate, and high) in 3 groups of 6 participants.
The Timolol will be released slowly through the implant for up to 1 year (main phase).
Approximately 1 year after the TimoD implant is placed into the eye and in absence of contraindications, the participants will be invited to continue the study in an extension phase. If the participants agree to enter the extension phase and the study investigator confirms it is safe for them, the TimoD implant will remain in the study eye for one additional year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving signed informed consent.
- •In good general and mental health without ongoing clinically significant abnormalities in medical history.
- •Clinically proven diagnosis of primary open-angle glaucoma (POAG) in the previous 12 months.
- •Subjects with IOP not adequately controlled with the standard medication.
- •Pseudophakia.
排除标准
- •Concomitant treatment with timolol (systemic), corticosteroids, cytochrome P450 2D6 inhibitors, or α2-agonists.
- •Subjects with a history of hypersensitivity or contraindications to β-blockers.
- •Significant risks caused by washout of ocular hypotensive medications.
- •History of any glaucoma not specified as POAG.
- •History of elevated IOP due to corticosteroid use.
- •History of ocular trauma.
研究组 & 干预措施
Group3: TimoD implant-Dose 3 (high dose)
Participants in Group 3 will receive a high dose of TimoD implant in the study eye on Day 1 if all participants in Group 2 have completed a 4-week treatment period with the intermediate dose, providing there are no safety issues in Group 2.
干预措施: TimoD implant (Drug)
Group 1: TimoD implant-Dose 1 (low dose)
Participants in the Group 1 will receive a low dose of TimoD implant in the study eye on Day 1.
干预措施: TimoD implant (Drug)
Group 1: TimoD implant-Dose 1 (low dose)
Participants in the Group 1 will receive a low dose of TimoD implant in the study eye on Day 1.
干预措施: Injector system (Device)
Group 2: TimoD implant-Dose 2 (intermediate dose)
Participants in Group 2 will receive an intermediate dose of TimoD implant in the study eye on Day 1 if all participants in Group 1 have completed a 4-week treatment period with the lowest dose of TimoD implant, providing there are no safety issues in Group 1.
干预措施: TimoD implant (Drug)
Group 2: TimoD implant-Dose 2 (intermediate dose)
Participants in Group 2 will receive an intermediate dose of TimoD implant in the study eye on Day 1 if all participants in Group 1 have completed a 4-week treatment period with the lowest dose of TimoD implant, providing there are no safety issues in Group 1.
干预措施: Injector system (Device)
Group3: TimoD implant-Dose 3 (high dose)
Participants in Group 3 will receive a high dose of TimoD implant in the study eye on Day 1 if all participants in Group 2 have completed a 4-week treatment period with the intermediate dose, providing there are no safety issues in Group 2.
干预措施: Injector system (Device)
结局指标
主要结局
Number and proportion of participants experiencing one or more serious adverse events (SAEs)
时间窗: From screening visit (up to Day -41) to end of study (Week 108)
Number and proportion of participants experiencing one or more treatment-emergent adverse events (TEAEs) overall and by dose group
时间窗: From screening visit (up to Day -41) to end of study (Week 108)
次要结局
未报告次要终点