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

Nu Eyne Co., Ltd.3 sites in 1 country25 target enrollmentOctober 5, 2022

ConditionsEarly to Moderate Dry Age-Related Macular Degeneration

DrugsTranscutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Early to Moderate Dry Age-Related Macular Degeneration
Sponsor: Nu Eyne Co., Ltd.
Enrollment: 25
Locations: 3
Primary Endpoint: Number of Safety Events
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 5, 2022

End Date

June 30, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nu Eyne Co., Ltd.

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Number of Safety Events

Time Frame: baseline ~ 16 weeks

Check the safety issues(AE, SAE, etc.).

Secondary Outcomes

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