NCT07024732已完成1 期
An Open-label Single Ascending Dose Safety and Tolerability Clinical Trial of PST-611 in Subjects With Dry Age-related Macular Degeneration
Eyevensys4 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2025年6月23日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The goal of this interventional study is to evaluate the safety and tolerability of single ascending doses of PST-611 in men and women over the age of 50 with dry age-related macular degeneration (AMD).
The main question it aims to answer is: Is PST-611-CT1 safe for participants?
Participants will:
- Receive a single dose of PST-611
- Will be followed up for a total of 16 weeks following PST-611 administration
详细描述
The maximum study duration per patient is 28 Weeks (including an up to 12 week screening period + 16 weeks of follow-up after treatment).
The study is a single ascending dose study that investigates two PST-611 dose levels (low and high doses) in 2 successive dose groups. The study will enroll up to 12 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •must give written informed consent, be able to make the required trial visits and follow instructions.
- •Female and male subjects 50 years of age or older.
- •Female subjects of childbearing potential must not be pregnant or breast-feeding and must have a negative urine pregnancy test at baseline and throughout the study. They must agree to practice at least one effective method of birth control following administration of study medication.
- •In the study eye (SE) : at least one of the following must be present at OCT and attributed to AMD, as evaluated by the Investigator: Incomplete RPE and Outer Retinal Atrophy (iRORA), or Complete RPE and Outer Retinal Atrophy (cRORA).
- •In SE: BCVA must be 23 ETDRS letters (approximate Snellen equivalent 20/320) or better.
- •In the fellow eye: BCVA must be 34 letters (approximate Snellen equivalent 20/200) or better.
排除标准
- •- Both eyes: any active intraocular or periocular infection or inflammation (eg, infectious blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis), or history of intraocular or periocular infection or inflammation in the 12 weeks (84 days) prior to the PST-611 administration.
- •Study eye: Any intraocular surgery (including cataract surgery) or intravitreal (IVT) or periocular corticosteroid injection within 12 weeks (84 days) prior to the PST-611 administration.
- •SE: Any anti-VEGF IVT treatment within 4 weeks (28 days) prior to PST-611 dosing OR subjects who have required and received regular monthly injections of anti-VEGF drugs in the months preceding the trial and would thus have a higher likelihood of requiring and anti-VEGF treatment within 28 days of the PST-611 administration.
- •SE: media opacity that interferes with fundus imaging or is likely to require surgery during the trial period.
- •SE: subject with history of glaucoma filtering surgery (e.g. trabeculectomy or aqueous shunt implant) or who underwent eye surgery within 12 weeks (84 days) of the PST-611 administration.
- •SE: subject who has uncontrolled intraocular pressure of ≥ 25 mmHg in the SE at the screening and baseline visits.
研究组 & 干预措施
Active treatment
Experimental
This arm consists of 2 dose groups receiving a single ascending dose of PST-611. These groups will be dosed sequentially, low dose followed by high dose.
干预措施: PST-611 (Biological)
结局指标
主要结局
Safety and Tolerability
时间窗: Screening to week 16
Ocular and non-ocular adverse events frequency and severity
次要结局
- Intraocular pressure(Screening to Week 16)
- Best corrected visual acuity(Screening to Week 16)
- Slit lamp biomicroscopy examination(Screening to Week 16)
- Dilated ophthalmoscopy examination(Screening to Week 16)
- Color fundus photography(Screening to Week 16)
- Spectral Domain-Optical Coherence Tomography(Screening to Week 16)
研究者
研究点 (4)
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