Early to Moderate Dry Age-Related Macular DegenerationNCT05259371
Study of Application of Transcutaneous Pulsed Electrical Stimulation Around Eye in Age-related Macular Degeneration
A study testing Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02) in people with Early to Moderate Dry Age-Related Macular Degeneration, run by Nu Eyne Co., Ltd. at 3 sites in South Korea.
Trial summary
This study aims to evaluate the safety and efficacy of applying pulse electrical stimulation around eyes of age-related macular patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Early to Moderate Dry Age-Related Macular Degeneration
- What is being tested?
- Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 5 Oct 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 15355
Cheol Min Yun, M.D., Ph.D.
Cheol Min Yun, M.D., Ph.D.
- Recruiting
Asan Medical Center
Seoul, 05505
Yoon Jeon Kim, M.D., Ph.D.
Yoon Jeon Kim, M.D., Ph.D.
- Not yet recruiting
Nune Eye Hospital
Seoul, 06192
Jong Min Kim, M.D., MS.
Jong Min Kim, M.D., MS.
About this study
Official title: 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.
Read the 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).
- Being tested
- Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)
- Keywords
- Age-related macular degeneration, Macular degeneration, Early to Moderate Dry AMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)Drug
Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Pulsed Electrical Stimulation Treatment | Experimental | Patients wear our clinical trial device 30mins once a day for 16weeks. Device: Nu eyne M02 Receives: Drug: Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Safety Events
Check the safety issues(AE, SAE, etc.).
Measured: baseline ~ 16 weeks
Secondary outcomes (7)
Changes in contrast sensitivity
Check the change of contrast sensitivity in the baseline, 6, 16 weeks
Measured: baseline, 6, 16 weeks
Changes in score of VFQ-25(National Eye Institute)
Check the change of Changes in score of VFQ-25(National Eye Institute) in the baseline, 6, 16 weeks
Measured: baseline, 6, 16 weeks
Changes in best corrected visual acuity(Early Treatment Diabetic Retinopathy Study (ETDRS) Chart)
Check the change of best corrected visual acuity in the baseline, 6, 16 weeks
Measured: baseline, 6, 16 weeks
Changes in drusen area using optical coherence tomography(OCT)
Check the change of drusen area using optical coherence tomography(OCT) in the baseline, 6, 16 weeks
Measured: baseline, 6, 16 weeks
Changes in drusen volume using optical coherence tomography(OCT)
Check the change of drusen volume using optical coherence tomography(OCT) in the baseline, 6, 16 weeks
Measured: baseline, 6, 16 weeks
Progression to advanced Age-related Macular Degeneration (AMD) using fundus autofluorescence(FAF)
Check the Progression to advanced Age-related Macular Degeneration (AMD) using fundus autofluorescence(FAF) in the baseline, 6, 16 weeks
Measured: baseline, 6, 16 weeks
Progression to advanced Age-related Macular Degeneration (AMD) using fundus photography
Check the Progression to advanced Age-related Macular Degeneration (AMD) using fundus photography in the baseline, 6, 16 weeks
Measured: baseline, 6, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start5 Oct 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early to Moderate Dry Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- • Experimental: Transcutaneous Pulsed Electrical Stimulation Treatment Patients wear our clinical trial device 30mins once a day for 16weeks. Device: Nu eyne M02
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nu Eyne Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259371
- Sponsor's protocol ID
- NE_RTN_002
- Status last verified
- Sep 2023
- First submitted
- 11 Feb 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05259371
- Acronym / sponsor ID
- NE_RTN_002
- Keywords
- Age-related macular degeneration, Macular degeneration, Early to Moderate Dry AMD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Nu Eyne Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- • Experimental: Transcutaneous Pulsed Electrical Stimulation Treatment Patients wear our clinical trial device 30mins once a day for 16weeks. Device: Nu eyne M02
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Pulsed Electrical Stimulation Treatment | Experimental | Drug: Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)Patients wear our clinical trial device 30mins once a day for 16weeks. Device: Nu eyne M02 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 50 years or older
- Has a confirmed diagnosis of early to moderate AMD
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks. | Drug | Transcutaneous Pulsed Electrical Stimulation Treatment |
Primary outcome
Number of Safety Events
Time frame: baseline ~ 16 weeks
Check the safety issues(AE, SAE, etc.).
7 secondary outcomes
Changes in contrast sensitivity
Time frame: baseline, 6, 16 weeks
Changes in score of VFQ-25(National Eye Institute)
Time frame: baseline, 6, 16 weeks
Changes in best corrected visual acuity(Early Treatment Diabetic Retinopathy Study (ETDRS) Chart)
Time frame: baseline, 6, 16 weeks
Changes in drusen area using optical coherence tomography(OCT)
Time frame: baseline, 6, 16 weeks
Changes in drusen volume using optical coherence tomography(OCT)
Time frame: baseline, 6, 16 weeks
Progression to advanced Age-related Macular Degeneration (AMD) using fundus autofluorescence(FAF)
Time frame: baseline, 6, 16 weeks
Progression to advanced Age-related Macular Degeneration (AMD) using fundus photography
Time frame: baseline, 6, 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02) in people with Early to Moderate Dry Age-Related Macular Degeneration, run by Nu Eyne Co., Ltd. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinho Jung, Ph.D candidate (+821083113509, jinho.jung@nueyne.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Safety Events (time frame: baseline ~ 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.