Dry Age-Related Macular DegenerationNCT07700147
Evaluation of an Electric Stimulator for Medical Use by Personal (LRTPM1) for Visual Function in Early to Intermediate Dry Age-Related Macular Degeneration
A study testing Transcutaneous Electrical Stimulation in people with Dry Age-Related Macular Degeneration and AMD, run by Nu Eyne Co., Ltd. at 3 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dry Age-Related Macular Degeneration, AMD
- What is being tested?
- Transcutaneous Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 9 Jul 2026to 17 Apr 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Youngmin Park, PhD contact
South Korea3 sites
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 15355
Cheol Min Yun, M.D., Ph.D., +82 031-412-5160, yuncheolmin@korea.ac.kr
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Eun Kyoung Lee, M.D., Ph.D., +82 02-2072-0617, righthanded8282@gmail.com
Asan Medical Center
Seoul, 05505
Yoon Jeon Kim, M.D., Ph.D., +82 02-3010-1670, anne215@gmail.com
About this study
Official title: 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:
Read more
- 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
Read the detailed description
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.
- Conditions
- Dry Age-Related Macular Degeneration, AMD
- Being tested
- Transcutaneous Electrical Stimulation, Sham Transcutaneous Electrical Stimulation
- Keywords
- Neurostimulation, Electrical stimulation, ES, stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical StimulationDevice
Also called TES, Electrical stimulation, neuromodulation, Neurostimulation
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.
Sham Transcutaneous Electrical StimulationDevice
Also called Sham
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (Active Stimulation, n=20) | Experimental | 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. Receives: Device: Transcutaneous Electrical Stimulation |
| Control Group (Sham Stimulation, n=20) | Sham comparator | 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. Receives: Device: Sham Transcutaneous Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best Corrected Visual Acuity (BCVA) Measured by ETDRS Letter Score
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.
Measured: Baseline, Week 2, Week 6, Week 12, Week 16
Change in Contrast Sensitivity
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.
Measured: Baseline, Week 2, Week 6, Week 12, Week 16
Secondary outcomes (4)
Change From Baseline in Geographic Atrophy Maximum Diameter and Area on Fundus Autofluorescence
Change from baseline in the maximum diameter and area of geographic atrophy as assessed by fundus autofluorescence imaging.
Measured: Baseline, Week 2, Week 6, Week 12, Week 16
Change From Baseline in Drusen Area and Volume on Optical Coherence Tomography (OCT)
Change from baseline in drusen area and volume as assessed by optical coherence tomography (OCT).
Measured: Baseline, Week 6, Week 12, Week 16
Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Score
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.
Measured: Baseline, Week 12
Incidence of Treatment-Emergent Adverse Events (TEAEs)
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.
Measured: Baseline through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start9 Jul 2026 (estimated)
- Primary completion9 Dec 2027 (estimated)
- Study completion17 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nu Eyne Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dohyoung Kim, Study director, Nu Eyne Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700147
- Sponsor's protocol ID
- NE_RTN_003
- Other IDs
- 1957
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No