A Multicenter, Randomized, Double-Blind, Sham-Controlled, Parallel-Group Exploratory Clinical Trial Evaluating the Efficacy and Safety of an Electric Stimulator for Medical Use by Personal (LRTPM1) in Improving Visual Function in Patients With Early to Intermediate Dry Age-Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Change in Best Corrected Visual Acuity (BCVA) Measured by ETDRS Letter Score
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of an electric stimulator for medical use by personal (LRTPM1) in patients with early to intermediate dry age-related macular degeneration.
The main questions this study aims to answer are:
- Does the investigational device improve visual function, as assessed by best corrected visual acuity and contrast sensitivity?
- What treatment-emergent adverse events occur during the study?
Participants will:
- Be randomized to receive either active stimulation or sham stimulation
- Apply the assigned investigational device at home once daily for 30 minutes over a 12-week treatment period
- Visit the study site for eye examinations and safety assessments
- Return for a follow-up visit 4 weeks after the end of treatment
详细描述
This study is a multicenter, randomized, double-blind, sham-controlled, parallel-group exploratory clinical trial designed to evaluate the efficacy and safety of an electric stimulator for medical use by personal (LRTPM1) in patients with early to intermediate dry age-related macular degeneration. Eligible participants will be randomized to receive either active stimulation or sham stimulation and will apply the assigned investigational device at home once daily for 30 minutes over a 12-week treatment period, followed by a 4-week post-treatment follow-up visit. The primary objective is to evaluate changes in visual function, as assessed by best corrected visual acuity measured using the ETDRS visual acuity chart and contrast sensitivity testing. Secondary objectives include evaluating changes in geographic atrophy parameters on fundus autofluorescence, drusen area and volume on optical coherence tomography, and vision-related quality of life as assessed by the NEI VFQ-25. Safety will be evaluated based on treatment-emergent adverse events, vital signs, physical examinations, and ophthalmic examinations throughout the study period.
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, Investigator)
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
- •Participants aged 50 years or older
- •Participants diagnosed with early or intermediate dry age-related macular degeneration
- •Participants with best corrected visual acuity measured by the ETDRS visual acuity chart of 20/200 or better and 20/30 or worse
- •Participants who have voluntarily decided to participate in the study and have provided written informed consent.
排除标准
- •Participants with atrophy involving the foveal center with a diameter of 175 micrometers or greater in at least one eye, as observed by fundus examination or fundus autofluorescence imaging
- •Participants with exudative age-related macular degeneration in at least one eye, as observed by fundus examination or optical coherence tomography (OCT)
- •Participants with a history of intraocular injection therapy or macular laser treatment, including focal laser photocoagulation or photodynamic therapy
- •Participants with retinal or choroidal diseases other than early or intermediate age-related macular degeneration that may affect the study results, including diabetic retinopathy, retinal artery occlusion, retinal vein occlusion, central serous chorioretinopathy, optic neuritis, or uveitis
- •Participants who have undergone vitrectomy due to retinal disease, or cataract surgery within 1 month prior to screening
- •Participants with ocular media opacity or other conditions that, in the investigator's opinion, may make ophthalmic imaging difficult to interpret, including cataract, vitreous opacity, or vitreous hemorrhage
- •Participants with uncontrolled chronic systemic diseases, including diabetes mellitus or chronic kidney disease, or a history of malignancy, except for cases with no recurrence within the past 5 years and no history of chemotherapy
- •Participants with autoimmune diseases, including Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, or Graves' disease
- •Participants with severe hearing impairment, sensory abnormalities, or cognitive impairment that may make it difficult to properly perform the study procedures or recognize or report adverse events
- •Participants who are hypersensitive to orbital nerve stimulation and are unable to receive treatment
- •Participants with a history of drug or alcohol abuse
- •Participants diagnosed with psychiatric disorders, including depression, schizophrenia, bipolar disorder, or dementia
- •Participants who have participated in another clinical trial within 30 days prior to screening
- •Participants who are considered to have other contraindications to use of the investigational medical device, including underlying cardiac disease, seizure-related disorders, implanted metal or electronic devices in the head or neck area including deep brain stimulators, unexplained pain, implanted or wearable pacemakers, or other conditions listed in the product precautions and contraindications. Dental implants are exempt.
- •Participants who, in the opinion of the investigator, are deemed inappropriate for participation in the study
- •Female participants of childbearing potential who do not agree to use medically accepted contraception during the study period. Medically accepted methods of contraception include condoms, oral contraceptives used consistently for at least 3 months, injectable or implantable contraceptives, or intrauterine devices.
研究组 & 干预措施
Experimental Group (Active Stimulation, n=20)
Participants randomized to the active stimulation group will receive the investigational electric stimulator for medical use by personal (LRTPM1). Participants will apply the assigned device at home once daily for 30 minutes over a 12-week treatment period, followed by a 4-week post-treatment follow-up.
干预措施: Transcutaneous Electrical Stimulation (Device)
Control Group (Sham Stimulation, n=20)
Participants randomized to the sham stimulation group will receive a sham device that is identical in appearance to the investigational device but does not provide active stimulation. Participants will apply the assigned device at home once daily for 30 minutes over a 12-week treatment period, followed by a 4-week post-treatment follow-up.
干预措施: Sham Transcutaneous Electrical Stimulation (Device)
结局指标
主要结局
Change in Best Corrected Visual Acuity (BCVA) Measured by ETDRS Letter Score
时间窗: Baseline, Week 2, Week 6, Week 12, Week 16
Change from baseline in best corrected visual acuity (BCVA) measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart. BCVA will be recorded as an ETDRS letter score. Higher scores indicate better visual acuity.
Change in Contrast Sensitivity
时间窗: Baseline, Week 2, Week 6, Week 12, Week 16
Change from baseline in contrast sensitivity as measured using a contrast sensitivity chart at four spatial frequencies (3, 6, 12, and 18 cycles/degree). Contrast sensitivity is recorded as a level value from 1 to 8, with higher recorded values indicating better ability to perceive contrast differences.
次要结局
- Change From Baseline in Geographic Atrophy Maximum Diameter and Area on Fundus Autofluorescence(Baseline, Week 2, Week 6, Week 12, Week 16)
- Change From Baseline in Drusen Area and Volume on Optical Coherence Tomography (OCT)(Baseline, Week 6, Week 12, Week 16)
- Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Score(Baseline, Week 12)
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(Baseline through Week 16)