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

NCT07700147 | Not Yet Recruiting

• 2 other identifiers: NE_RTN_0031957
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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. 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

Conditions

AMD; Dry Age-Related Macular Degeneration

Keywords

Neurostimulation; Electrical stimulation; ES; stimulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

Study Arms (2)

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.

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.

Device: Sham Transcutaneous Electrical Stimulation

Interventions

Transcutaneous Electrical Stimulation DEVICE

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.

Also known as: TES, Electrical stimulation, neuromodulation, Neurostimulation

Experimental Group (Active Stimulation, n=20)

Sham Transcutaneous Electrical Stimulation DEVICE

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.

Also known as: Sham

Control Group (Sham Stimulation, n=20)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nu Eyne Co., Ltd.: lead

Study Sites (3)

Korea University Ansan Hospital

Ansan, Gyeonggi-do, 15355, South Korea

Location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation; Electric Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Physical Stimulation; Investigative Techniques

Study Officials

• Dohyoung Kim

  Nu Eyne Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Eunmi Choi, MEng

CONTACT

+821082418099; eunmi.choi@nueyne.com

Youngmin Park, PhD

CONTACT

youngmin.park@nueyne.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: July 9, 2026
• Primary Completion (Estimated): December 9, 2027
• Study Completion (Estimated): April 17, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)