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| ID | Type | Description | Link |
|---|---|---|---|
| 1957 | Other Identifier | Ministry of Food and Drug Safety(MFDS) |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 2, Week 6, Week 12, Week 16 |
| Change From Baseline in Drusen Area and Volume on Optical Coherence Tomography (OCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eunmi Choi, MEng | Contact | +821082418099 | eunmi.choi@nueyne.com | |
| Youngmin Park, PhD | Contact | youngmin.park@nueyne.com |
| Name | Affiliation | Role |
|---|---|---|
| Dohyoung Kim | Nu Eyne Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan | Gyeonggi-do | 15355 | South Korea |
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| 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. |
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Change from baseline in drusen area and volume as assessed by 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 | 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. | 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. | Baseline through Week 16 |
| Seoul National University Hospital | Seoul | Jongno-gu | 03080 | South Korea |
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| Asan Medical Center | Seoul | 05505 | South Korea |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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