NCT05259371招募中不适用
A 16-Week, Multi-Center, Open-Label, Exploratory Study to Evaluate the Safety and Efficacy of the Application of Pulse Electrical Stimulation Around the Eye in Early to Moderate Dry Age-Related Macular Degeneration
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Number of Safety Events
研究概览
简要总结
This study aims to evaluate the safety and efficacy of applying pulse electrical stimulation around eyes of age-related macular patients.
详细描述
Duration of study period(per participant): Screening period(0-4weeks), Intervention period(16weeks) Patient needs to visit site at least 5 times(Screening, V2, V3, V4, V5). V2 can be done with screening visit. Visit 3, 4, 5 is 2weeks, 6weeks, and 16weeks after visit 2(Baseline).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years or older
- •Has a confirmed diagnosis of early to moderate AMD
- •According to Staging of age-related macular degeneration of Beckman Initiative for Macular Research Classification Committee
- •early AMD: Medium drusen(>63 μm; ≤125 μm) and No AMD pigmentary abnormalities
- •moderate AMD: Large drusen(>125 μm) and/or Any AMD pigmentary abnormalities
- •Best Corrected Visual Acuity [BCVA] of 20/200 or better measured by Early Treatment Diabetic Retinopathy Study(ETDRS) Charts
- •A person who voluntarily agreed to participate in this clinical trial
排除标准
- •Subject who is observed to have a atrophy of 175 micrometers or more in diameter invading the fovea on fundus examination or fundus autofluorescent with more than one eye
- •Subject who is observed to have exudative macular degeneration on fundus examination or optical coherence tomography(OCT) with more than one eye
- •Has a history of intravitreal injection, laser treatment, etc.
- •Has eye pathology other than early age-related macular degeneration that may affect the outcome of clinical trials.
- •Has a history of vitrectomy due to macular disease or cataract surgery within 1 month
- •Has a disease that is judged to be difficult to interpret an ophthalmic imaging examination due to ocular media opacity
- •Has a history of uncontrollable systemic chronic disease(diabetes mellitus) or malignancy(cases that have not recurred for more than 5 years after complete recovery are excluded)
- •Autoimmune disease(Sjögren's syndrome, Rheumatoid arthritis, systemic lupus erythematosus, Graves' disease, etc.)
- •Has a severe hearing impairment
- •A person who is sensitive to orbit nerve stimulation and cannot be treated.
- •Has a history of substance and/or alcohol abuse
- •Has a confirmed diagnosis of psychiatric disease(depression, schizophrenia, bipolar disorder, dementia, etc)
- •Those who participated in other clinical trials within 30 days of the screening visit
- •Those who are judged to have "other reasons for prohibition of use" of our clinical trial medical device: heart-related problems. seizure. Patients transplanted metal or electronic device in head & neck including deep brain stimulation device. Patient suffering from unknown pain. Patients with implantable or wearable cardioverter defibrillator. Patients who are warned not to use out clinical trial device or is prohibited from using it. (Dental implants are accepted.)
- •In the case of subjects judged by the researcher that it would be difficult to participate in clinical trials
- •Among female subjects who are likely to be pregnant, those who disagree to contraception in a medically permitted manner during this clinical trial period.
- •Medically permitted contraception: condom, Oral contraception that lasted for at least 3 months, contraceptive injection, contraceptive implant, intrauterine device, etc.
结局指标
主要结局
Number of Safety Events
时间窗: baseline ~ 16 weeks
Check the safety issues(AE, SAE, etc.).
次要结局
- Changes in drusen area using optical coherence tomography(OCT)(baseline, 6, 16 weeks)
- Changes in drusen volume using optical coherence tomography(OCT)(baseline, 6, 16 weeks)
- Progression to advanced Age-related Macular Degeneration (AMD) using fundus autofluorescence(FAF)(baseline, 6, 16 weeks)
- Progression to advanced Age-related Macular Degeneration (AMD) using fundus photography(baseline, 6, 16 weeks)
- Changes in contrast sensitivity(baseline, 6, 16 weeks)
- Changes in score of VFQ-25(National Eye Institute)(baseline, 6, 16 weeks)
- Changes in best corrected visual acuity(Early Treatment Diabetic Retinopathy Study (ETDRS) Chart)(baseline, 6, 16 weeks)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Study of Application of Pulse Electrical Stimulation Around Eye in Glaucoma PatientsGlaucomaNCT05159414Nu Eyne Co., Ltd.18
招募中
不适用
Study of Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Who Are Scheduled for Laser Epithelial Keratomileusis (LASEK) SurgeryDry Eye DiseaseNCT06120348Nu Eyne Co., Ltd.178
已完成
不适用
Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Scheduled for LASEK SurgeryDry Eye DiseaseNCT05271422Nu Eyne Co., Ltd.24
招募中
不适用
BCI Driving FES and Hand Orthosis for Upper Limb Rehabilitation in Chronic StrokeStroke, CerebrovascularHemiplegia and HemiparesisStroke/Brain AttackNCT06179745University of Essex32
已完成
不适用
Safety and Efficacy of Electronic Stimulation for Circumferential Reduction and Muscle ToningFat NecrosisMuscle StimulationNCT06152900LUTRONIC Corporation45