Age-Related Macular Degenerationi-SIGHTNCT05447650
Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT)
A study testing i-Lumen(TM) AMD in people with Age-Related Macular Degeneration and Dry Age-related Macular Degeneration, run by i-Lumen Scientific, Inc. at 10 sites in United States.
Trial summary
Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Dry Age-related Macular Degeneration, Nonexudative Age-related Macular Degeneration
- What is being tested?
- i-Lumen(TM) AMD
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 10 sitesUnited States
- Study dates
- 12 Apr 2022to 15 Jun 2025
- 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
- Age ≥50 years.
- Non-exudative age-related macular degeneration defined as AREDS category 3 Intermediate AMD and/or geographic atrophy
- Best-corrected distance visual acuity 20/40 to 20/200 (inclusive) in the study eye, and BCVA 20/100 or better in the fellow eye
Who cannot join
- History and/or evidence of exudative age-related macular degeneration in either eye
- History and/or evidence of diabetic retinopathy in either eye
- Current tobacco or tobacco-related product use or history within the past 10 years of heavy smoking (on average, more than half a pack of cigarettes per day)
- Central chorioretinal atrophy in the study eye
- Glaucoma in the study eye
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Austin Research Center for Retina
Austin, Texas, 78705
Retina Consultants of Texas
Bellaire, Texas, 77401
Star Retina
Burleson, Texas, 76028
Cumberland Valley Retina Consultants
Chambersburg, Pennsylvania, 21740
Erie Retina Research, LLC
Erie, Pennsylvania, 16507
Texas Retina Associates
Fort Worth, Texas, 76104
Charles Retina Institute
Germantown, Tennessee, 38138
University Retina and Macula Associates, PC
Lemont, Illinois, 60439
Associated Retina Consultants
Phoenix, Arizona, 85020
Bay Area Retina Associates
Walnut Creek, California, 94598
About this study
Official title: Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT): A Multicenter, Randomized, Sham-controlled, Feasibility Device Trial.
Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (AMD).
Read the detailed description
The i-Lumen(TM) AMD device is for in-office therapy use to deliver microcurrent electrical stimulation transpalpebrally (via the eyelid) for use by an ophthalmologist. The i-Lumen AMD device contains proprietary software with preset treatment algorithms and is calibrated at each session to the individual participant.
Up to 30 enrolled participants will be randomized (2:1 active to sham ratio) and complete the initial 5-day loading treatment sessions. Participants completing the initial loading sessions will receive two (2) days of maintenance treatments and be following and be followed through the one (1) year time point.
- Conditions
- Age-Related Macular Degeneration, Dry Age-related Macular Degeneration, Nonexudative Age-related Macular Degeneration
- Being tested
- i-Lumen(TM) AMD, i-Lumen(TM) AMD Sham
- Keywords
- AMD, 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.
i-Lumen(TM) AMDDevice
Transpalpebral microcrurrent stimulation
i-Lumen(TM) AMD ShamDevice
Transpalpebral sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| i-Lumen AMD Active | Experimental | Active transpalpebral microcurrent stimulation therapy Receives: Device: i-Lumen(TM) AMD |
| i-Lumen AMD Sham | Sham comparator | Sham transpalpebral microcurrent stimulation therapy Receives: Device: i-Lumen(TM) AMD Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Device Effects
Incidence of device- and/or treatment-related serious adverse events (SAEs) and/or serious adverse device effects (SADE) at any point during the study
Measured: Through study completion, Month 12 timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start12 Apr 2022
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- i-Lumen Scientific, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meredith Mundy, Study director, i-Lumen Scientific, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447650
- Sponsor's protocol ID
- ILS-AMD-201
- Acronym
- i-SIGHT
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2022
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT): A Multicenter, Randomized, Sham-controlled, Feasibility Device Trial.
- ClinicalTrials.gov ID
- NCT05447650
- Acronym / sponsor ID
- i-SIGHT / ILS-AMD-201
- Conditions
- Age-Related Macular Degeneration, Dry Age-related Macular Degeneration, Nonexudative Age-related Macular Degeneration
- Keywords
- AMD, Dry AMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- i-Lumen Scientific, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 7 Jul 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.
Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (AMD).
Detailed description
The i-Lumen(TM) AMD device is for in-office therapy use to deliver microcurrent electrical stimulation transpalpebrally (via the eyelid) for use by an ophthalmologist. The i-Lumen AMD device contains proprietary software with preset treatment algorithms and is calibrated at each session to the individual participant.
Up to 30 enrolled participants will be randomized (2:1 active to sham ratio) and complete the initial 5-day loading treatment sessions. Participants completing the initial loading sessions will receive two (2) days of maintenance treatments and be following and be followed through the one (1) year time point.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-Lumen AMD Active | Experimental | Device: i-Lumen(TM) AMDActive transpalpebral microcurrent stimulation therapy |
| i-Lumen AMD Sham | Sham comparator | Device: i-Lumen(TM) AMD ShamSham transpalpebral microcurrent stimulation therapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥50 years.
- Non-exudative age-related macular degeneration defined as AREDS category 3 Intermediate AMD and/or geographic atrophy
- Best-corrected distance visual acuity 20/40 to 20/200 (inclusive) in the study eye, and BCVA 20/100 or better in the fellow eye
Key exclusion criteria (5 listed)
- History and/or evidence of exudative age-related macular degeneration in either eye
- History and/or evidence of diabetic retinopathy in either eye
- Current tobacco or tobacco-related product use or history within the past 10 years of heavy smoking (on average, more than half a pack of cigarettes per day)
- Central chorioretinal atrophy in the study eye
- Glaucoma in the study eye
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 |
|---|---|---|
| i-Lumen(TM) AMDTranspalpebral microcrurrent stimulation | Device | i-Lumen AMD Active |
| i-Lumen(TM) AMD ShamTranspalpebral sham stimulation | Device | i-Lumen AMD Sham |
Primary outcome
Adverse Device Effects
Time frame: Through study completion, Month 12 timepoint
Incidence of device- and/or treatment-related serious adverse events (SAEs) and/or serious adverse device effects (SADE) at any point during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Meredith Mundy study director
i-Lumen Scientific, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-Lumen(TM) AMD in people with Age-Related Macular Degeneration and Dry Age-related Macular Degeneration, run by i-Lumen Scientific, Inc. at 10 sites in United States.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Device Effects (time frame: Through study completion, Month 12 timepoint). 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 24 Jun 2025.