NCT06662162招募中不适用
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2): a Multicentre, Randomised, Sham-controlled, Double-masked, Clinical Device Trial.
i-Lumen Scientific AUS PTY LTD28 个研究点 分布在 4 个国家目标入组 100 人开始时间: 2025年5月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 28
- 主要终点
- Mean Change BCVA from Baseline
研究概览
简要总结
The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD.
Participants will:
- Undergo an initial loading regimen, followed by 7 maintenance over the course of 11 months.
- Participants will return monthly through Month 14 (3 months post-last treatment) for evaluation and monitoring.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of at least one large druse >125 microns in diameter due to AMD.
- •BCVA letter score of 35 to 70 letters (inclusive) (Snellen equivalent 6/12 to 6/60 [20/40 to 20/200])
排除标准
- •Any implanted electrical device(s) including deep brain stimulator, hearing or visual implants (i.e., cochlear implant, auditory brainstem implant, retinal prostheses), and/or cardiac defibrillator/pacemaker.
- •Implanted metallic device within 20 cm of the Treatment electrode (study eye(s)) and/or the grounding electrode (base of the hairline on the back of the neck).
- •Uncontrolled diabetes, defined as glycated haemoglobin (HbA1c) >10% (13.3 mmol/L).
- •Current tobacco or tobacco-related product use or history within the past 5 years of heavy smoking (defined as, on average, more than half a pack of cigarettes per day).
- •Known severe allergy to fluorescein dye.
- •Medical diagnosis of severe dry eye defined as requiring either artificial tears more than six (6) times a day or prescription drops (i.e., Restasis, Xiidra, or Cequa).
- •History of seizure disorders, chronic migraines and/or cluster headaches.
- •History and/or evidence of diabetic retinopathy in either eye as assessed by CF, fundus fluorescein angiography (FA), and OCT, to be confirmed by the Central Reading Centre.
- •Other conditions which pre-dispose to chorioretinal atrophy such as inherited retinal dystrophy (i.e., Stargardt's disease, Best's disease, pattern dystrophy, central areolar choroidal dystrophy, etc.).
- •History and/or evidence of exudative AMD in the study eye as assessed by CF, FA (or OCT-A ), and OCT, to be confirmed by Central Reading Centre.
- •GA involving the foveal centre, as assessed by the Central Reading Centre using AF and OCT.
- •History of intravitreal injections for GA (e.g., Syfovre or Izervay).
- •Treatment with photobiomodulation (PBM) therapy or short pulse laser within 12 months prior to screening.
- •Glaucoma requiring ≥3 medications and/or drops per day, or history of trabeculectomy.
- •History of any kind of intraocular surgery, excluding cataract surgery performed ≥3 months from Screening.
- •History of yttrium aluminium garnet (YAG) laser posterior capsulotomy <1 month from Screening.
- •Visually significant cataracts and/or visually significant posterior capsular opacification.
- •History of amblyopia.
研究组 & 干预措施
Active i-Lumen AMD therapy
Experimental
Active transpalpebral microcurrent therapy
干预措施: i-Lumen AMD (Device)
Sham i-Lumen AMD therapy
Sham Comparator
Sham transpalpebral microcurrent therapy
干预措施: i-Lumen AMD (Device)
结局指标
主要结局
Mean Change BCVA from Baseline
时间窗: Month 3
Mean change in per-eye (treated study eye \[unilateral\] or treated primary study eye \[bilateral\]) from Baseline in distance BCVA letter score on the ETDRS VA chart, active vs sham.
次要结局
- Portion of per-eye Responders(Month 3)
- Mean Change BCVA from Baseline(Month 6)
- Portion of per-eye Responders(Month 3)
- Mean Change BCVA from Baseline(Month 6)
研究者
研究点 (28)
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