RecruitingNAINTERVENTIONAL

Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration

This research is investigating a new treatment called i-Lumen AMD for a common eye condition known as age-related macular degeneration (AMD). Specifically, it's for people with intermediate to advanced 'dry' AMD, where there isn't any leaking or bleeding in the eye. The i-Lumen AMD device uses a very small electric current, applied near the eye. The main goals of the study are to find out if this treatment is safe and if it can help stop the condition from getting worse. Participants will have treatments over 11 months, followed by several months of check-ups to see how they're doing. This study hopes to offer a new way to manage AMD, a condition that can affect your eyesight as you get older.

At a glance

Status

Recruiting

Phase

Sponsor

i-Lumen Scientific AUS PTY LTD

Enrolment target

100

Start

07 May 2025

Estimated completion

31 Dec 2029

What is this study about?

This study is exploring a new way to help people with a common eye condition called Age-related Macular Degeneration (AMD). If you have AMD, it affects the central part of your vision, which is important for things like reading and recognising faces. This study is specifically for a type of 'dry' AMD, which means there isn't any leaking or bleeding in the eye.

The new treatment being tested is called i-Lumen AMD. It involves using a very gentle electrical current, applied near the eye, to see if it can help the way your eye works. Researchers want to understand if this treatment is safe for people to use and if it can effectively slow down the progression of AMD, especially in those with intermediate to advanced stages of the condition. They hope this could offer a new option for managing sight.

The study will follow participants closely. If you take part, you'll have a course of treatments over approximately 11 months, followed by several months of regular check-ups. These check-ups are important for the medical team to see how your eyes are responding and to make sure the treatment is safe for you. This kind of research is vital for finding new and better ways to help people living with eye conditions.

Key takeaways

This study is testing a new 'microcurrent' device for 'dry' AMD.
It aims to check if the i-Lumen AMD device is safe and effective.
The study is for people with intermediate to advanced dry AMD.
Participation involves regular treatments for about 11 months, then check-ups.
The total time commitment for the study is around 14 months.
It could potentially offer a new way to manage AMD, but it's a research study.

Who may be eligible?

To be considered for this study, you would need to have specific findings in your eye exams consistent with AMD, particularly with at least one 'large druse' – which are small yellow deposits under the retina. Your eyesight would also need to fall within a certain range, meaning it's not too good and not too bad, as measured by standard eye charts.

There are also reasons why you might not be able to join. For example, if you have certain electronic devices implanted in your body, like a pacemaker or some types of hearing or vision implants, you wouldn't be able to take part. Similarly, if you have metal implants close to where the treatment would be applied, or a history of seizures, severe dry eye, or uncontrolled diabetes, you wouldn't be suitable.

The study also cannot include individuals who have other eye conditions that might be confused with AMD, or if you've recently had other eye treatments like specific laser therapies or injections for a different type of AMD. If you smoke heavily or have done so recently, that would also exclude you.

Quick self-check

Do you have a diagnosis of intermediate to advanced 'dry' AMD?
Do you have a specific type of yellow deposit (called 'drusen') in your eye?
Is your eyesight within a specific range (not too good, not too poor)?
Do you have any implanted electronic devices like a pacemaker or hearing implant?
Do you have any metal implants near your eye or neck?
Are you a heavy smoker or have you been in the last 5 years?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first have an initial period of treatments, followed by monthly follow-up treatments for about 11 months in total. This means you would be having treatment regularly over this period.

After your treatment period finishes, you would continue to visit the clinic once a month for another three months. So, in total, you could expect to be involved in the study for about 14 months. These monthly visits are for the medical team to check your eyes, see how you're responding to the treatment, and make sure everything is okay.

Potential risks and benefits

Participating in this study might offer a potential benefit of slowing down the progression of your AMD, but it's important to remember this is a new treatment, and its effectiveness is still being investigated. As with any medical procedure, there could be risks or side effects, although the study is designed to be as safe as possible. You will be closely monitored throughout. It's important to know that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (13)

Retina Consultants PC
Manchester, United States· Not yet recruiting
University Retina & Macula Associates
Lemont, United States· Not yet recruiting
Texas Retina Associates
Fort Worth, United States· Not yet recruiting
Tyler Retina Research Insitute
Tyler, United States· Not yet recruiting
Sydney Eye Hospital
Sydney, Australia· Recruiting
Hobart Eye Surgeons
Hobart, Australia· Recruiting
Adelaide Eye & Retina Centre
Adelaide, Australia· Recruiting
Cerulea
East Melbourne, Australia· Recruiting
Auckland Eye Limited
Remuera, New Zealand· Recruiting
Southern Eye Specialist
Christchurch, New Zealand· Recruiting
King's College Hospital
London, United Kingdom· Recruiting
London North West University Healthcare
Middlesex, United Kingdom· Recruiting

+1 more sites — see the official record for the full list.

Common questions

What is Age-related Macular Degeneration (AMD)?

AMD is an eye condition that affects the macula, the central part of your retina, which is responsible for sharp eyesight needed for reading and recognising faces. It often develops as people get older.

What does 'nonexudative' mean?

This simply means 'dry' AMD. It's the most common type and doesn't involve any leaking or bleeding in the eye, unlike 'wet' AMD.

How does the i-Lumen AMD treatment work?

The i-Lumen AMD device uses a very gentle electrical current applied near the eye. The researchers are trying to see if this microcurrent can help improve or stabilize the condition of the eye in people with AMD.

Will I have to pay to be part of the study?

No, you should not have to pay for any study-related treatments or visits. This will be explained fully by the study team.

Can I stop participating if I change my mind?

Yes, taking part in a clinical trial is always voluntary. You can choose to leave the study at any time, for any reason, and it will not affect the medical care you receive.

How to find out more

Meredith Mundy

mmundy@i-lumen.com.au 408-440-7049 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.