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

September 6, 2023 updated by: Nu Eyne Co., Ltd.

A 16-Week, Multi-Center, Open-Label, Exploratory Study to Evaluate the Safety and Efficacy of the Application of Pulse Electrical Stimulation Around the Eye in Early to Moderate Dry Age-Related Macular Degeneration

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Yoon Jeon Kim, M.D., Ph.D.
        • Principal Investigator:
          • Yoon Jeon Kim, M.D., Ph.D.
      • Seoul, Korea, Republic of, 06192
        • Not yet recruiting
        • Nune Eye Hospital
        • Contact:
          • Jong Min Kim, M.D., MS.
        • Principal Investigator:
          • Jong Min Kim, M.D., MS.
    • Gyeonggi-do
      • Ansan, Gyeonggi-do, Korea, Republic of, 15355
        • Recruiting
        • Korea University Ansan Hospital
        • Contact:
          • Cheol Min Yun, M.D., Ph.D.
        • Principal Investigator:
          • Cheol Min Yun, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous Pulsed Electrical Stimulation Treatment
Patients wear our clinical trial device 30mins once a day for 16weeks. Device: Nu eyne M02
Drug: Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)
Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Safety Events
Time Frame: baseline ~ 16 weeks
Check the safety issues(AE, SAE, etc.).
baseline ~ 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in contrast sensitivity
Time Frame: baseline, 6, 16 weeks
Check the change of contrast sensitivity in the baseline, 6, 16 weeks
baseline, 6, 16 weeks
Changes in score of VFQ-25(National Eye Institute)
Time Frame: baseline, 6, 16 weeks
Check the change of Changes in score of VFQ-25(National Eye Institute) in the baseline, 6, 16 weeks
baseline, 6, 16 weeks
Changes in best corrected visual acuity(Early Treatment Diabetic Retinopathy Study (ETDRS) Chart)
Time Frame: baseline, 6, 16 weeks
Check the change of best corrected visual acuity in the baseline, 6, 16 weeks
baseline, 6, 16 weeks
Changes in drusen area using optical coherence tomography(OCT)
Time Frame: baseline, 6, 16 weeks
Check the change of drusen area using optical coherence tomography(OCT) in the baseline, 6, 16 weeks
baseline, 6, 16 weeks
Changes in drusen volume using optical coherence tomography(OCT)
Time Frame: baseline, 6, 16 weeks
Check the change of drusen volume using optical coherence tomography(OCT) in the baseline, 6, 16 weeks
baseline, 6, 16 weeks
Progression to advanced Age-related Macular Degeneration (AMD) using fundus autofluorescence(FAF)
Time Frame: baseline, 6, 16 weeks
Check the Progression to advanced Age-related Macular Degeneration (AMD) using fundus autofluorescence(FAF) in the baseline, 6, 16 weeks
baseline, 6, 16 weeks
Progression to advanced Age-related Macular Degeneration (AMD) using fundus photography
Time Frame: baseline, 6, 16 weeks
Check the Progression to advanced Age-related Macular Degeneration (AMD) using fundus photography in the baseline, 6, 16 weeks
baseline, 6, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nu Eyne Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

February 11, 2022

First Submitted That Met QC Criteria

February 25, 2022

First Posted (Actual)

February 28, 2022

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NE_RTN_002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Early to Moderate Dry Age-Related Macular Degeneration

Clinical Trials on Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe