Applying electrical stimulation around the eyes for age-related macular degeneration
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 is testing if a device that sends gentle electrical pulses around the eyes can help improve vision in older adults with early to moderate dry age-related macular degeneration.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Nu Eyne Co., Ltd. Industry-sponsored |
| Locations | 3 sites (Ansan, Gyeonggi-do and 2 other locations) |
| Trial ID | NCT05259371 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of transcutaneous pulsed electrical stimulation applied around the eyes of patients with early to moderate dry age-related macular degeneration (AMD). Participants aged 50 and older will undergo a screening period followed by a 16-week intervention period, during which they will visit the study site at least five times for assessments and treatment. The intervention involves the use of a device called Nu Eyne M02 to deliver electrical stimulation. The study aims to determine if this approach can improve visual function in affected individuals.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with a confirmed diagnosis of early to moderate AMD and a best-corrected visual acuity of 20/200 or better.
Not a fit: Patients with advanced AMD, including those with significant foveal atrophy or exudative macular degeneration, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option to improve vision in patients with early to moderate AMD.
How similar studies have performed: While the approach of using electrical stimulation for AMD is relatively novel, similar studies have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ansan, Gyeonggi-do and 2 other locations
- Korea University Ansan Hospital — Ansan, Gyeonggi-do, Korea, Republic of (Recruiting)
- Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
- Nune Eye Hospital — Seoul, Korea, Republic of (Not_yet_recruiting)
Study contacts
- Study coordinator: Jinho Jung, Ph.D candidate
- Email: jinho.jung@nueyne.com
- Phone: +821083113509
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.