Evaluation of an Electric Stimulator for Medical Use by Personal (LRTPM1) for Visual Function in Early to Intermediate Dry Age-Related Macular Degeneration

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Transcutaneous Electrical Stimulation
  The active intervention uses transcutaneous electrical stimulation (TES) delivered by the investigational personal-use electric stimulator (LRTPM1). Electrodes are attached to the ocular and periocular area, and the device delivers pulsed electrical stimulation. Participants will apply the assigned device once daily for 30 minutes over a 12-week treatment period.
• Устройство Sham Transcutaneous Electrical Stimulation
  The sham device is identical in appearance to the active investigational device but does not provide active electrical stimulation. Participants will apply the assigned sham device once daily for 30 minutes over a 12-week treatment period.

Первичные конечные точки

• Change in Best Corrected Visual Acuity (BCVA) Measured by ETDRS Letter Score [Срок оценки: Baseline, Week 2, Week 6, Week 12, Week 16]
• Change in Contrast Sensitivity [Срок оценки: Baseline, Week 2, Week 6, Week 12, Week 16]

Вторичные конечные точки (4)

• Change From Baseline in Geographic Atrophy Maximum Diameter and Area on Fundus Autofluorescence [Срок оценки: Baseline, Week 2, Week 6, Week 12, Week 16]
• Change From Baseline in Drusen Area and Volume on Optical Coherence Tomography (OCT) [Срок оценки: Baseline, Week 6, Week 12, Week 16]
• Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Score [Срок оценки: Baseline, Week 12]
• Incidence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Baseline through Week 16]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

South Korea · 3 центра

• Korea University Ansan Hospital — Ansan
• Seoul National University Hospital — Seoul
• Asan Medical Center — Seoul

Идентификаторы

NCT: NCT07700147 · NE_RTN_003 · 1957

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗