NCT05259371RecruitingNot Applicable
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Nu Eyne Co., Ltd.
- Enrollment
- 25
- Locations
- 3
- Primary Endpoint
- Number of Safety Events
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Transcutaneous Pulsed Electrical Stimulation Treatment
Experimental
Patients wear our clinical trial device 30mins once a day for 16weeks. Device: Nu eyne M02
Intervention: Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02) (Drug)
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)
Investigators
Study Sites (3)
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