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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07700147
- Acronym / sponsor ID
- NE_RTN_003
- Conditions
- Dry Age-Related Macular Degeneration, AMD
- Keywords
- Neurostimulation, Electrical stimulation, ES, stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nu Eyne Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2026 (estimated)
- Primary completion
- 9 Dec 2027 (estimated)
- Study completion
- 17 Apr 2028 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (Active Stimulation, n=20) | Experimental | Device: Transcutaneous Electrical StimulationParticipants 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. |
| Control Group (Sham Stimulation, n=20) | Sham comparator | Device: Sham Transcutaneous Electrical StimulationParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical StimulationAlso: TES, Electrical stimulation, neuromodulation, NeurostimulationThe 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. | Device | Experimental Group (Active Stimulation, n=20) |
| Sham Transcutaneous Electrical StimulationAlso: ShamThe 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. | Device | Control Group (Sham Stimulation, n=20) |
Primary outcome
Change in Best Corrected Visual Acuity (BCVA) Measured by ETDRS Letter Score
Time frame: 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
Time frame: 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.
4 secondary outcomes
Change From Baseline in Geographic Atrophy Maximum Diameter and Area on Fundus Autofluorescence
Time frame: Baseline, Week 2, Week 6, Week 12, Week 16
Change From Baseline in Drusen Area and Volume on Optical Coherence Tomography (OCT)
Time frame: Baseline, Week 6, Week 12, Week 16
Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Score
Time frame: Baseline, Week 12
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline through Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Youngmin Park, PhD contact
Dohyoung Kim study director
Nu Eyne Co., Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eunmi Choi, MEng (+821082418099, eunmi.choi@nueyne.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Best Corrected Visual Acuity (BCVA) Measured by ETDRS Letter Score (time frame: Baseline, Week 2, Week 6, Week 12, Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.