Early to Moderate Dry Age-Related Macular Degeneration
Conditions
Keywords
Age-related macular degeneration, Macular degeneration, Early to Moderate Dry AMD
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).
Interventions
Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks.
Sponsors
Nu Eyne Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
• Experimental: Transcutaneous Pulsed Electrical Stimulation Treatment Patients wear our clinical trial device 30mins once a day for 16weeks. Device: Nu eyne M02
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Safety Events | baseline ~ 16 weeks | Check the safety issues(AE, SAE, etc.). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression to advanced Age-related Macular Degeneration (AMD) using fundus autofluorescence(FAF) | baseline, 6, 16 weeks | Check the Progression to advanced Age-related Macular Degeneration (AMD) using fundus autofluorescence(FAF) in the baseline, 6, 16 weeks |
| Changes in contrast sensitivity | baseline, 6, 16 weeks | Check the change of contrast sensitivity in the baseline, 6, 16 weeks |
| Changes in score of VFQ-25(National Eye Institute) | baseline, 6, 16 weeks | Check the change of Changes in score of VFQ-25(National Eye Institute) in the baseline, 6, 16 weeks |
| Changes in drusen volume using optical coherence tomography(OCT) | baseline, 6, 16 weeks | Check the change of drusen volume using optical coherence tomography(OCT) in the baseline, 6, 16 weeks |
| Changes in drusen area using optical coherence tomography(OCT) | baseline, 6, 16 weeks | Check the change of drusen area using optical coherence tomography(OCT) in the baseline, 6, 16 weeks |
| Progression to advanced Age-related Macular Degeneration (AMD) using fundus photography | baseline, 6, 16 weeks | Check the Progression to advanced Age-related Macular Degeneration (AMD) using fundus photography in the baseline, 6, 16 weeks |
| Changes in best corrected visual acuity(Early Treatment Diabetic Retinopathy Study (ETDRS) Chart) | baseline, 6, 16 weeks | Check the change of best corrected visual acuity in the baseline, 6, 16 weeks |
Countries
South Korea
Contacts
Primary ContactJinho Jung, Ph.D candidate
Backup ContactNayoung Kang
Outcome results
None listed