Age-Related Macular Degenerationi-SIGHT2NCT06662162
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
A study testing i-Lumen AMD in people with Age-Related Macular Degeneration and Age-related Macular Degeneration (ARMD), run by i-Lumen Scientific AUS PTY LTD at 13 sites in 4 countries.
Trial summary
The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD. Participants will: Undergo an initial loading regimen, followed by 7 maintenance over the course of 11 months. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Age-related Macular Degeneration (ARMD), Intermediate AMD
- What is being tested?
- i-Lumen AMD
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 7 May 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of at least one large druse >125 microns in diameter due to AMD.
- BCVA letter score of 35 to 70 letters (inclusive) (Snellen equivalent 6/12 to 6/60 [20/40 to 20/200])
Who cannot join
- Any implanted electrical device(s) including deep brain stimulator, hearing or visual implants (i.e., cochlear implant, auditory brainstem implant, retinal prostheses), and/or cardiac defibrillator/pacemaker.
- Implanted metallic device within 20 cm of the Treatment electrode (study eye(s)) and/or the grounding electrode (base of the hairline on the back of the neck).
- Uncontrolled diabetes, defined as glycated haemoglobin (HbA1c) >10% (13.3 mmol/L).
- Current tobacco or tobacco-related product use or history within the past 5 years of heavy smoking (defined as, on average, more than half a pack of cigarettes per day).
- Known severe allergy to fluorescein dye.
- Medical diagnosis of severe dry eye defined as requiring either artificial tears more than six (6) times a day or prescription drops (i.e., Restasis, Xiidra, or Cequa).
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- History of seizure disorders, chronic migraines and/or cluster headaches.
- History and/or evidence of diabetic retinopathy in either eye as assessed by CF, fundus fluorescein angiography (FA), and OCT, to be confirmed by the Central Reading Centre.
- Other conditions which pre-dispose to chorioretinal atrophy such as inherited retinal dystrophy (i.e., Stargardt's disease, Best's disease, pattern dystrophy, central areolar choroidal dystrophy, etc.).
- History and/or evidence of exudative AMD in the study eye as assessed by CF, FA (or OCT-A ), and OCT, to be confirmed by Central Reading Centre.
- GA involving the foveal centre, as assessed by the Central Reading Centre using AF and OCT.
- History of intravitreal injections for GA (e.g., Syfovre or Izervay).
- Treatment with photobiomodulation (PBM) therapy or short pulse laser within 12 months prior to screening.
- Glaucoma requiring ≥3 medications and/or drops per day, or history of trabeculectomy.
- History of any kind of intraocular surgery, excluding cataract surgery performed ≥3 months from Screening.
- History of yttrium aluminium garnet (YAG) laser posterior capsulotomy <1 month from Screening.
- Visually significant cataracts and/or visually significant posterior capsular opacification.
- History of amblyopia.
Trial locations and contacts
13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 4 countries
United States7 sites, 7 recruiting
- Recruiting
Retina Associates of Cleveland
Beachwood, Ohio, 44122
Diane Research Coordinator, (216) 831-5700, dweiss@retina-assoc.com
Maureen Research Coordinator, (440) 663-0022, mcunningham@retina-assoc.com
- Recruiting
Texas Retina Associates
Fort Worth, Texas, 76104
Lori Research Coordinator, 817-334-0882 x411, lmullen@texasretina.com
Patrick Williams, MD
- Recruiting
University Retina & Macula Associates
Lemont, Illinois, 60439
Clinical Research Manager, 708-765-4110, swheatley@uretina.com
- Recruiting
Retina Consultants PC
Manchester, Connecticut, 06042
Chris Research Coordinator, 860-646-7704 x113, cdwy@retinact.com
Noam Rudnick, MD
- Recruiting
Retina Consultants San Diego
Poway, California, 92064
Research Coordinator, 858-451-1911, dcarbajal@rcsd.com
Nicholas London, MD
- Not yet recruiting
Sierra Eye Associates
Reno, Nevada, 89502
Mandi Research Coordinator, 775-329-0286, mseverson@sierraeyeassociates.com
Arshad Khanani
- Recruiting
Tyler Retina Research Insitute
Tyler, Texas, 75703
Melissa Long Research Coordinator, 903-597-4644, mlong@tylerretina.com
Samuel Minaker, MD
United Kingdom4 sites, 4 recruiting
- Recruiting
Queens University Belfast / Belfast City Hospital
Belfast
Therese Research Coordinator, +44 02895 040342, t.kearney@qub.ac.uk
Tunde Peto
- Recruiting
King's College Hospital
London, SE5 9RS
Nikki Research Coordinator, +44 203 299 7791, noimottimson@nhs.net
Timothy Jackson, PhD, FRCOphth
- Recruiting
London North West University Healthcare
Middlesex, HA1 3UJ
Sandali Research Coordinator, +44 (0) 208 453 2077, snammuniarachchge@nhs.net
Christiana Dinah, BSc, MB BS, MRes, FRCOphth
- Recruiting
Sunderland Eye Infirmary
Sunderland, SR2 9HP
SEI Research Nurses Research Coordinator, 0191 5699074, stsft.seiresearchnurses@nhs.net
Ajay Kotagiri
New Zealand1 site, 1 recruiting
- Recruiting
Auckland Eye Limited
Remuera, Auckland, 1050
Alice Research Coordinator, 64 09 529 2480, Alice@aucklandeye.co.nz
Riyaz Bhikoo
About this study
Official title: Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2): a Multicentre, Randomised, Sham-controlled, Double-masked, Clinical Device Trial.
The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD.
Participants will:
- Undergo an initial loading regimen, followed by 7 maintenance over the course of 11 months.
- Participants will return monthly through Month 14 (3 months post-last treatment) for evaluation and monitoring.
- Conditions
- Age-Related Macular Degeneration, Age-related Macular Degeneration (ARMD), Intermediate AMD, Geographic Atrophy Secondary to Age-related Macular Degeneration
- Being tested
- i-Lumen AMD
- Keywords
- AMD, Intermediate AMD, Dry AMD, Geographic Atrophy
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-Lumen AMDDevice
i-Lumen AMD transpalpebral microcurrent stimulation system
| Study group | Role | What they receive |
|---|---|---|
| Active i-Lumen AMD therapy | Experimental | Active transpalpebral microcurrent therapy Receives: Device: i-Lumen AMD |
| Sham i-Lumen AMD therapy | Sham comparator | Sham transpalpebral microcurrent therapy Receives: Device: i-Lumen AMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change BCVA from Baseline
Mean change in per-eye (treated study eye [unilateral] or treated primary study eye [bilateral]) from Baseline in distance BCVA letter score on the ETDRS VA chart, active vs sham.
Measured: Month 3
Secondary outcomes (2)
Portion of per-eye Responders
- Difference in proportion of per-eye (treated study eye [unilateral] or treated primary study eye [bilateral]) gaining ≥10 letters from Baseline in distance BCVA ETDRS, active vs sham.
Measured: Month 3
Mean Change BCVA from Baseline
Mean change in per-eye (treated study eye [unilateral] or treated primary study eye [bilateral]) from Baseline in distance BCVA letter score on the ETDRS VA chart, active vs sham.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start7 May 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 Randomization of active to sham therapy
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- i-Lumen Scientific AUS PTY LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- i-Lumen Scientific, Inc.
- Responsible party
- Sponsor
- Investigators
- Meredith Mundy, Study director, i-Lumen Scientific, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662162
- Sponsor's protocol ID
- ILS-AMD-202
- Acronym
- i-SIGHT2
- Status last verified
- Aug 2026
- First submitted
- 25 Oct 2024
- Last updated
- 26 Aug 2026
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2): a Multicentre, Randomised, Sham-controlled, Double-masked, Clinical Device Trial.
- ClinicalTrials.gov ID
- NCT06662162
- Acronym / sponsor ID
- i-SIGHT2 / ILS-AMD-202
- Conditions
- Age-Related Macular Degeneration, Age-related Macular Degeneration (ARMD), Intermediate AMD, Geographic Atrophy Secondary to Age-related Macular Degeneration
- Keywords
- AMD, Intermediate AMD, Dry AMD, Geographic Atrophy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- i-Lumen Scientific AUS PTY LTDIndustry (pharma, biotech, devices)
- Collaborators
- i-Lumen Scientific, Inc.
- Study start
- 7 May 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Oct 2024 (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.
The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD.
Participants will:
- Undergo an initial loading regimen, followed by 7 maintenance over the course of 11 months.
- Participants will return monthly through Month 14 (3 months post-last treatment) for evaluation and monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 2:1 Randomization of active to sham therapy
| Arm | Type | Receives |
|---|---|---|
| Active i-Lumen AMD therapy | Experimental | Device: i-Lumen AMDActive transpalpebral microcurrent therapy |
| Sham i-Lumen AMD therapy | Sham comparator | Device: i-Lumen AMDSham transpalpebral microcurrent therapy |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of at least one large druse >125 microns in diameter due to AMD.
- BCVA letter score of 35 to 70 letters (inclusive) (Snellen equivalent 6/12 to 6/60 [20/40 to 20/200])
Key exclusion criteria (18 listed)
- Any implanted electrical device(s) including deep brain stimulator, hearing or visual implants (i.e., cochlear implant, auditory brainstem implant, retinal prostheses), and/or cardiac defibrillator/pacemaker.
- Implanted metallic device within 20 cm of the Treatment electrode (study eye(s)) and/or the grounding electrode (base of the hairline on the back of the neck).
- Uncontrolled diabetes, defined as glycated haemoglobin (HbA1c) >10% (13.3 mmol/L).
- Current tobacco or tobacco-related product use or history within the past 5 years of heavy smoking (defined as, on average, more than half a pack of cigarettes per day).
- Known severe allergy to fluorescein dye.
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 AMDi-Lumen AMD transpalpebral microcurrent stimulation system | Device | Active i-Lumen AMD therapy, Sham i-Lumen AMD therapy |
Primary outcome
Mean Change BCVA from Baseline
Time frame: Month 3
Mean change in per-eye (treated study eye [unilateral] or treated primary study eye [bilateral]) from Baseline in distance BCVA letter score on the ETDRS VA chart, active vs sham.
2 secondary outcomes
Portion of per-eye Responders
Time frame: Month 3
Mean Change BCVA from Baseline
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- 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.
Meredith Mundy study director
i-Lumen Scientific, Inc.
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-Lumen AMD in people with Age-Related Macular Degeneration and Age-related Macular Degeneration (ARMD), run by i-Lumen Scientific AUS PTY LTD at 13 sites in 4 countries.
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 2 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, United Kingdom, Australia, New Zealand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meredith Mundy (408-440-7049, mmundy@i-lumen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change BCVA from Baseline (time frame: Month 3). 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 26 Aug 2026.