At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- i-Lumen AMD (device)
- How long the study runs
- Study runs about 55 months (dates as stated)
- About the drug or intervention
- i-Lumen AMD — device: i-Lumen AMD transpalpebral microcurrent stimulation system
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at a treatment called microcurrent stimulation therapy for people with intermediate to advanced 'dry' age-related macular degeneration (AMD) — an eye condition that can blur central vision as we get older. Microcurrent stimulation uses very tiny electrical currents. The sponsor is i-Lumen Scientific AUS PTY LTD. The aim is not fully described in the data provided — ask the trial team for more details.
Who can take part
- Age-related macular degeneration with at least one large drusen (fatty deposit) larger than 125 microns in the eye
- Vision between 6/12 and 6/60 on a Snellen chart (a letter score of 35 to 70)
Who may not be able to
- Any implanted electrical device, such as a pacemaker, defibrillator, cochlear implant or retinal implant
- Metal implants near the eye being treated or near the back of the neck where a grounding pad sits
- Poorly controlled diabetes (HbA1c above 10%)
- Currently smoking, or a history of heavy smoking (more than half a pack a day) within the past 5 years
- Severe allergy to fluorescein dye (used in some eye tests)
- Severe dry eye needing artificial tears more than 6 times a day or prescription dry-eye drops
- History of seizures, chronic migraines or cluster headaches
- Diabetic retinopathy (eye damage from diabetes) in either eye
- Other eye conditions that cause similar damage, such as Stargardt's disease or Best's disease
- Wet AMD in the study eye
- Geographic atrophy (advanced cell loss) affecting the very centre of the retina
- Previous eye injections for geographic atrophy, such as Syfovre or Izervay
- Light therapy (photobiomodulation) or short pulse laser treatment in the past 12 months
- Glaucoma needing 3 or more medications a day, or previous glaucoma surgery (trabeculectomy)
- Any eye surgery in the past, except cataract surgery done at least 3 months ago
- YAG laser capsulotomy within the past month
- Cataracts or clouding that significantly affects vision
- Lazy eye (amblyopia)
What taking part involves
- • Microcurrent stimulation therapy, which uses very small electrical currents applied near the eye — Not stated — ask the trial team for details on how it is given
Time commitment: Not stated — ask the trial team about the number of visits, how long the trial lasts and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 60 Years and over
- Who
- All
- Number of participants
- 100
- Started
- 2025-05-07
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for age-related macular degeneration
- • NA - 100 participants
- • 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
Who can take part?
- • Ages 60 Years and over
- • Diagnosed with age-related macular degeneration
Where?
- • Belfast - Queens University Belfast / Belfast City Hospital
- • London - King's College Hospital
- • Middlesex - London North West University Healthcare
- • Sunderland - Sunderland Eye Infirmary
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 60 Years and over
- Who can join: All genders
What the study is looking for
- ✓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 take part
- ✗Implanted metallic device within 20 cm of the Treatment electrode (study eye(s)) and/or the grounding electrode...
- ✗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...
- ✗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...
See the full criteria
Where Is This Study? (4 UK sites)
Queens University Belfast / Belfast City Hospital
Belfast, United Kingdom
King's College Hospital
London SE5 9RS, United Kingdom
London North West University Healthcare
Middlesex HA1 3UJ, United Kingdom
Sunderland Eye Infirmary
Sunderland SR2 9HP, United Kingdom
How to Get in Touch
Meredith Mundy
Sponsor contactCONTACT
