Early Feasibility Study to Evaluate the Safety and Efficacy of a New Timolol Sustained-Release Intraocular Implant (TimoD) in Participants With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) Undergoing Cataract Surgery
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- EyeD Pharma
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Stage 1: Number (%) of participants experiencing adverse events
研究概览
简要总结
The goal of this clinical trial is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma or ocular hypertension and requiring cataract surgery.
The study is conducted in two stages. The first stage (Stage 1/Phase 1) is intended to study the safety of 3 different doses of the study medication (called TimoD implant). The second stage (Stage 2/Phase 2) of the study is intended to study in greater detail the efficacy and safety of the 3 doses of the TimoD implant in comparison to a standard approved medication, timolol eye drops for 3 years.
详细描述
Timolol will be administered using an investigational drug product called the TimoD implant.
The implant will be placed in one eye (the study eye) using an instrument called an injector system (an investigational device). The implant procedure will be performed during cataract surgery.
Stage 1: Three dose levels of the TimoD implant (low, intermediate, and high) will be evaluated in three groups of six participants each. Participants will be assigned sequentially to a treatment group and will receive a single implant containing one of the three dose levels. Participants in Stage 1 will be followed for 1 year.
Stage 2: The same three dose levels of the TimoD implant will be evaluated further. In addition, a fourth treatment group receiving an approved control treatment (timolol eye drops) will be included. Six participants will be randomized to each treatment group. Participants in Stage 2 will be followed for 3 years.
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.
- •Open-angle glaucoma or ocular hypertension and age-related cataract eligible for intra-capsular IOL placement.
- •Successful, uncomplicated cataract surgery
排除标准
- •Subjects with a history of hypersensitivity or contraindications to β- blockers.
- •Participants using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure
- •Significant risks caused by washout of ocular hypotensive medications.
- •Clinically significant ocular pathology other than OHT, glaucoma and cataract.
结局指标
主要结局
Stage 1: Number (%) of participants experiencing adverse events
时间窗: From Screening (up to Day -41) to end of stage 1 (Month 13)
Stage 2: Proportion of responders defined as an IOP decrease of 20% or more between baseline and Month 3 (8 AM IOP)
时间窗: Month 3
Stage 1: Number (%) of participants experiencing adverse events of special interest (AESI)
时间窗: From Screening (up to Day -41) to end of stage 1 (Month 13)
Stage 2: Proportion of time-matched responders defined as an IOP decrease of 20% or more between baseline and Month 3 (8 AM and 10 AM)
时间窗: Month 3
Number (%) of participants experiencing adverse events
时间窗: From Screening (up to Day -41) to end of study (Month 13)
Number (%) of participants experiencing adverse events of special interest (AESI)
时间窗: From Screening (up to Day -41) to end of study (Month 13)
次要结局
未报告次要终点