Study of Application of Transcutaneous Pulsed Electrical Stimulation Around Eye in Age-related Macular Degeneration

NCT ID: NCT05259371

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-05
• Study Completion Date: 2024-06-30

Brief Summary

This study aims to evaluate the safety and efficacy of applying pulse electrical stimulation around eyes of age-related macular patients.

Detailed Description

Duration of study period(per participant): Screening period(0-4weeks), Intervention period(16weeks) Patient needs to visit site at least 5 times(Screening, V2, V3, V4, V5). V2 can be done with screening visit. Visit 3, 4, 5 is 2weeks, 6weeks, and 16weeks after visit 2(Baseline).

Conditions

Early to Moderate Dry Age-Related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcutaneous Pulsed Electrical Stimulation Treatment

Patients wear our clinical trial device 30mins once a day for 16weeks. Device: Nu eyne M02

Group Type: EXPERIMENTAL

Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)

Intervention Type: DRUG

Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks.

Interventions

Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)

Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 50 years or older
• Has a confirmed diagnosis of early to moderate AMD

• According to Staging of age-related macular degeneration of Beckman Initiative for Macular Research Classification Committee

• early AMD: Medium drusen(>63 μm; ≤125 μm) and No AMD pigmentary abnormalities
• moderate AMD: Large drusen(>125 μm) and/or Any AMD pigmentary abnormalities
• Best Corrected Visual Acuity [BCVA] of 20/200 or better measured by Early Treatment Diabetic Retinopathy Study(ETDRS) Charts
• A person who voluntarily agreed to participate in this clinical trial

Exclusion Criteria

• Subject who is observed to have a atrophy of 175 micrometers or more in diameter invading the fovea on fundus examination or fundus autofluorescent with more than one eye
• Subject who is observed to have exudative macular degeneration on fundus examination or optical coherence tomography(OCT) with more than one eye
• Has a history of intravitreal injection, laser treatment, etc.
• Has eye pathology other than early age-related macular degeneration that may affect the outcome of clinical trials.
• Has a history of vitrectomy due to macular disease or cataract surgery within 1 month
• Has a disease that is judged to be difficult to interpret an ophthalmic imaging examination due to ocular media opacity
• Has a history of uncontrollable systemic chronic disease(diabetes mellitus) or malignancy(cases that have not recurred for more than 5 years after complete recovery are excluded)
• Autoimmune disease(Sjögren's syndrome, Rheumatoid arthritis, systemic lupus erythematosus, Graves' disease, etc.)
• Has a severe hearing impairment
• A person who is sensitive to orbit nerve stimulation and cannot be treated.
• Has a history of substance and/or alcohol abuse
• Has a confirmed diagnosis of psychiatric disease(depression, schizophrenia, bipolar disorder, dementia, etc)
• Those who participated in other clinical trials within 30 days of the screening visit
• Those who are judged to have "other reasons for prohibition of use" of our clinical trial medical device: heart-related problems. seizure. Patients transplanted metal or electronic device in head & neck including deep brain stimulation device. Patient suffering from unknown pain. Patients with implantable or wearable cardioverter defibrillator. Patients who are warned not to use out clinical trial device or is prohibited from using it. (Dental implants are accepted.)
• In the case of subjects judged by the researcher that it would be difficult to participate in clinical trials
• Among female subjects who are likely to be pregnant, those who disagree to contraception in a medically permitted manner during this clinical trial period.

• Medically permitted contraception: condom, Oral contraception that lasted for at least 3 months, contraceptive injection, contraceptive implant, intrauterine device, etc.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nu Eyne Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Korea University Ansan Hospital

Ansan, Gyeonggi-do, South Korea

Site Status: RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Nune Eye Hospital

Seoul, , South Korea

Site Status: NOT_YET_RECRUITING

Countries

South Korea

Central Contacts

Jinho Jung, Ph.D candidate

Role: CONTACT

jinho.jung@nueyne.com

+821083113509

Nayoung Kang

Role: CONTACT

nayoung.kang@nueyne.com

+821073734097

Facility Contacts

Cheol Min Yun, M.D., Ph.D.

Role: primary

Yoon Jeon Kim, M.D., Ph.D.

Role: primary

Jong Min Kim, M.D., MS.

Role: primary

Other Identifiers

NE_RTN_002

Identifier Type: -

Identifier Source: org_study_id