NCT07705568尚未招募2 期
An Open-label Multiple Dose Safety, Tolerability and Exploratory Efficacy Clinical Trial of PST-611 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
Eyevensys3 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The goals of this interventional study are (1) to evaluate the safety and tolerability of multiple doses of PST-611 in men and women over the age of 65 with geographic atrophy secondary to age-related macular degeneration and (2) to assess efficacy of multiple doses of PST-611 by assessing retinal morphology and visual function changes over time.
Participants will:
- receive one dose every 20 weeks, for a total of 3 doses.
- will be followed up for a total of 52 weeks following the first PST-611 dose.
详细描述
The maximum study duration per patient is 64 Weeks (including an up to 12 week screening/baseline period + 52 weeks of follow-up after the first dose). The study is a multiple dose study that investigates one PST-611 dose level for the 3 planned administrations. The study will enroll up to 24 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must give written informed consent, be able to make the required trial visits and follow instructions.
- •Female and male subjects must be 65 years of age or older.
- •In the study eye (SE): cRORA must be present on OCT and attributed to AMD, as evaluated by the Investigator.
- •Documented recent history (i.e., over 3 to 12 months prior to first PST-611 administration) of GA lesion area progression, with a yearly growth projection of ≥ 1.6 mm2, in the SE
- •GA lesion area prior to the first PST-611 administration must be between 1.25 mm2 and 16 mm2, as assessed by OCT, in SE.
- •BCVA must be < or = 75 ETDRS letters (Snellen < or = 20/32) in the SE.
- •Fixation, either central or eccentric, of both eyes, must be compatible with the performance of the ocular imaging and functional assessments included in the trial, as evaluated by the Investigator.
- •If both eyes are eligible, the SE will be selected by the Investigator based on the totality of the clinical evaluation.
排除标准
- •Both eyes (OU): 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 Dose
- •SE: any intraocular surgery (including cataract surgery) or intravitreal (IVT) or periocular corticosteroid injection in the 12 weeks (84 days) prior to Dose
- •SE: the documented need for more than 2 anti-VEGF IVT treatments per year as well as any anti-VEGF IVT treatment within 3 months prior to Dose 1, and lesion must be clinically inactive.
- •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 in the 12 weeks (84 days) prior to Dose
- •SE: subject who has uncontrolled intraocular pressure of ≥ 25 mmHg in the SE at the Screening and Trial Baseline Visits.
- •SE: subject with intraocular hypotension (<6 mmHg) in the SE that in the opinion of the Investigator would interfere with the PST-611 administrations or the evaluation of its safety or efficacy.
- •SE: subject with history of scleritis, scleral thinning, cicatrizing conjunctival diseases, severe ocular allergies, severe ocular surface disease, ocular scarring or intraocular hardware (e.g., retained implant device) that could interfere with the PST-611 administrations or the evaluation of its safety.
- •SE: any other concurrent ocular surface or intra-ocular condition, including retinal disease other than AMD, which, in the opinion of the Investigator, may pose a safety risk for the PST-611 administrations or interfere with the evaluation of its safety.
- •Subject has any condition, which in the opinion of the Investigator, could compromise the subject's safety or adherence to the trial protocol or follow-up.
- •Known/suspected hypersensitivity to any standard of care topical or local analgesics/anesthetics or other standard of care treatments used in the preparation of PST-611 administration procedure.
- •Treatment with investigational medicinal products in the 12 weeks (84 days) prior to Dose
- •Subject previously exposed to any gene therapy product other than the non-viral gene therapy PST-611.
结局指标
主要结局
Safety and Tolerability
时间窗: Screening to week 52
Ocular and non-ocular adverse events frequency and severity
Frequency and severity of ocular and non-ocular adverse events (Safety and Tolerability)
时间窗: Screening to week 52
Ocular and non-ocular adverse events over time will be recorded
次要结局
- Slit lamp biomicroscopy examination(Screening to week 52)
- Dilated ophthalmoscopy examination(Screening to week 52)
- Color fundus photography(Screening to week 52)
- Intraocular pressure(Screening to week 52)
- Best corrected visual acuity(Screening to week 52)
- Spectral Domain-Optical Coherence Tomography(Screening to week 52)
- Quantitative contrast sensitivity function(screening to week 52)
- Area of retinal pigment epithelium (RPE) loss(screening to week 52)
- Area of photoreceptor degeneration (EZ layer loss)(Screening to week 52)
研究者
研究点 (3)
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