Evaluation of an Electric Stimulator for Medical Use by Personal (LRTPM1) for Visual Function in Early to Intermediate Dry Age-Related Macular Degeneration
2026년 7월 7일 업데이트: Nu Eyne Co., Ltd.
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
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
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
40
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Eunmi Choi, MEng
- 전화번호: +821082418099
- 이메일: eunmi.choi@nueyne.com
연구 연락처 백업
- 이름: Youngmin Park, PhD
- 이메일: youngmin.park@nueyne.com
연구 장소
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-
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Seoul, 대한민국, 05505
- Asan Medical Center
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연락하다:
- Yoon Jeon Kim, M.D., Ph.D.
- 전화번호: +82 02-3010-1670
- 이메일: anne215@gmail.com
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Gyeonggi-do
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Ansan, Gyeonggi-do, 대한민국, 15355
- Korea University Ansan Hospital
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연락하다:
- Cheol Min Yun, M.D., Ph.D.
- 전화번호: +82 031-412-5160
- 이메일: yuncheolmin@korea.ac.kr
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Jongno-gu
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Seoul, Jongno-gu, 대한민국, 03080
- Seoul National University Hospital
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연락하다:
- Eun Kyoung Lee, M.D., Ph.D.
- 전화번호: +82 02-2072-0617
- 이메일: righthanded8282@gmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
다른 이름들:
|
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가짜 비교기: 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.
|
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Best Corrected Visual Acuity (BCVA) Measured by ETDRS Letter Score
기간: Baseline, Week 2, Week 6, Week 12, Week 16
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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.
|
Baseline, Week 2, Week 6, Week 12, Week 16
|
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Change in Contrast Sensitivity
기간: Baseline, Week 2, Week 6, Week 12, Week 16
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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.
|
Baseline, Week 2, Week 6, Week 12, Week 16
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Geographic Atrophy Maximum Diameter and Area on Fundus Autofluorescence
기간: Baseline, Week 2, Week 6, Week 12, Week 16
|
Change from baseline in the maximum diameter and area of geographic atrophy as assessed by fundus autofluorescence imaging.
|
Baseline, Week 2, Week 6, Week 12, Week 16
|
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Change From Baseline in Drusen Area and Volume on Optical Coherence Tomography (OCT)
기간: Baseline, Week 6, Week 12, Week 16
|
Change from baseline in drusen area and volume as assessed by optical coherence tomography (OCT).
|
Baseline, Week 6, Week 12, Week 16
|
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Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Score
기간: Baseline, Week 12
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Change from baseline in vision-related quality of life as assessed by the NEI VFQ-25.
The total score ranges from 0 to 100, with lower scores indicating better visual function.
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Baseline, Week 12
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Incidence of Treatment-Emergent Adverse Events (TEAEs)
기간: Baseline through Week 16
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Incidence and severity of treatment-emergent adverse events (TEAEs) occurring from the first investigational device application through Week 16.
TEAEs include, but are not limited to, transient dizziness, drowsiness, skin redness, skin allergy, headache, pain and muscle spasms, ocular symptoms such as transient eye pain, ocular discomfort, and ocular hyperemia, and hypersensitivity reactions around the application site.
Safety will be assessed through monitoring of vital signs, physical examinations, ophthalmic examinations, and adverse event reporting throughout the study period.
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Baseline through Week 16
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 연구 책임자: Dohyoung Kim, Nu Eyne Co., Ltd.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 7월 9일
기본 완료 (추정된)
기본 완료
2027년 12월 9일
연구 완료 (추정된)
연구 완료
2028년 4월 17일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 7일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 7일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 13일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 7일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- NE_RTN_003
- 1957 (기타 식별자: Ministry of Food and Drug Safety(MFDS))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .