NCT06557460招募中2 期
A Phase IIb, Randomized, Assessor-Masked, Multicenter Clinical Trial to Assess the Safety and Efficacy of Subretinal Implantation of the CPCB-RPE1 Implant in Subjects With Advanced, Dry Age-Related Macular Degeneration (Geographic Atrophy) - PATCH AMD
Regenerative Patch Technologies, LLC5 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- Change in retinal sensitivity
研究概览
简要总结
This is a Phase IIb randomized, clinical trial designed to assess the safety and efficacy of unilateral implantation of the CPCB-RPE1 implant in subjects with geographic atrophy involving the fovea.
Up to 6 surgical implantation sites will deliver the CPCB-RPE1 in this Phase IIb clinical trial. Additional study sites may serve as referral or follow-up sites. Twenty-four (24) subjects will participate in the trial and will be randomized 3:1 to one of 2 groups:
- The treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).
- The control group receiving a simulated "sham" implantation procedure (up to 6 subjects)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55 to 90 years of age (inclusive), presenting with geographic atrophy involving the fovea in advanced, age-related, dry AMD.
- •Clinical findings consistent with advanced dry AMD with evidence of one or more areas of ≥4.0mm2 but not exceeding 15.0 mm2 of geographic atrophy involving the fovea.
- •Geographic atrophy defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, or FAF.
- •The best-corrected visual acuity (BCVA) of the eye to receive the implant will be ≥20/200 (35 EDTRS letters) to 20/63 (60 EDTRS letters) inclusive. The BCVA of the eye that is NOT to receive the implant will be better or equal to the eye that will receive the implant.
- •Medically suitable to undergo pars plana vitrectomy and the surgical implant procedure, including being able to position post-operatively and use post-operative medications as required.
- •Medically suitable for general anesthesia or monitored intravenous sedation, if needed.
- •Pseudophakic in the study eye, to remove the risk of cataract formation following vitrectomy.
- •Participants also must be willing and able to provide written, signed informed consent for this study.
- •Participants able to complete the baseline microperimetry retinal sensitivity testing.
- •On baseline microperimetry, participants must have ≥5 spots in the perilesional region with a retinal sensitivity between 3 and 17 Db.
排除标准
- 未提供
研究组 & 干预措施
Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).
Experimental
Active treatment group receiving the CPCB-RPE1 implant (up to 18 subjects).
干预措施: Surgical implantation of the CPCB-RPE1 implant (Device)
Control group receiving a simulated "sham" implantation procedure (up to 6 subjects)
Sham Comparator
Control group receiving a simulated "sham" implantation procedure (up to 6 subjects)
干预措施: Surgical implantation of the CPCB-RPE1 implant (Device)
结局指标
主要结局
Change in retinal sensitivity
时间窗: 1 year post implantation
Change in retinal sensitivity by microperimetry
次要结局
- Change in best corrected visual acuity(1 year post implantation)
研究者
研究点 (5)
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