RecruitingNAINTERVENTIONAL

Photobiomodulation in Dry Age Related Macular Degeneration

This study investigates a new treatment using yellow and red light for people with dry age-related macular degeneration (AMD). AMD is an eye condition that can affect your central vision. The researchers want to find out if shining these special lights into the eye can reduce 'drusen' (small fatty deposits that build up), and if it can make your vision clearer and help you see contrasts better. People taking part will be split into two groups: one receiving the light treatment and another receiving a 'sham' (dummy) treatment, which feels similar but has no active light. This helps the researchers compare the effects accurately. The light treatment involves several sessions over a few weeks, with both continuous and pulsed light while eyes are closed and open. The aim is to see if this light therapy could be a helpful way to manage dry AMD.

At a glance

Status

Recruiting

Phase

Sponsor

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Enrolment target

180

Start

01 Apr 2023

Estimated completion

31 Dec 2024

Age-Related Macular Degeneration

What is this study about?

This research is focused on a common eye condition called dry age-related macular degeneration, often shortened to dry AMD. This condition affects your macula, which is the central part of your retina responsible for sharp, detailed vision, like when you’re reading or looking at faces. In dry AMD, small yellow deposits called drusen can build up, and the light-sensitive cells in your macula can gradually thin out, leading to blurry or distorted central vision.

Researchers are exploring a treatment called 'photobiomodulation' using special yellow and red lights. They want to see if these lights can help the eye's cells work better, potentially reducing these drusen deposits and improving vision. Think of it like giving your eye's cells a gentle boost of energy with specific types of light.

They're particularly interested in two things: whether the light therapy can reduce the amount of drusen in the eye, and if it can improve how well people see, including their general vision sharpness and their ability to see differences between light and dark (contrast sensitivity). By understanding this, doctors hope to find new ways to help people living with dry AMD.

Key takeaways

This study evaluates yellow and red light therapy for dry AMD.
It aims to see if light treatment reduces deposits and improves vision.
Participants will be randomly assigned to treatment or a dummy group.
Treatment involves specific light sessions over several weeks.
Researchers will compare objective eye changes and vision improvements.

Who may be eligible?

To be able to take part in this study, you need to meet certain requirements. The main ones are that you must have been diagnosed with dry age-related macular degeneration (AMD), and your vision in your better eye must be good enough to read at least 40 letters on a standard eye chart from a distance of 4 metres. This helps ensure that the study can accurately measure any changes in your vision.

You also need to be able to talk clearly with the research team and understand what's involved in the study. It's important that you can follow the study's instructions carefully so the results are reliable.

However, there are also reasons why you might not be able to join. For example, if you have epilepsy, certain brain conditions, serious mental health issues, or an active cold sore (herpes virus) infection, the treatment might not be suitable for you. If you have a very cloudy lens in your eye (dense cataract), are pregnant, or have other serious eye or general health problems, you would also not be able to participate. The study is open to anyone aged 50 or over, regardless of their gender.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged 50 or over?
Do you have a diagnosis of dry age-related macular degeneration (AMD)?
Is your vision good enough to read basic letters on an eye chart?
Do you feel you can understand and follow study instructions?
Do you NOT have epilepsy, serious mental health issues, or active cold sores?
Are you NOT pregnant and do NOT have particularly dense cataracts or other serious eye conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups: either the group receiving the special yellow and red light treatment or the group receiving a 'sham' (dummy) treatment. This means you won't know which treatment you're getting, which helps ensure the study results are fair and unbiased.

The light treatment involves two main cycles. The first cycle consists of 8 sessions over four weeks (twice a week). The second cycle involves 6 sessions over three weeks (also twice a week). Each session has two phases:

* **Phase 1:** You'll have yellow light shone into your eyes for a short time – first a continuous light with your eyes closed, then a pulsing light with your eyes open. * **Phase 2:** This is similar, but with red light instead – continuous light with eyes closed, then pulsing light with eyes open.

Throughout the study, the research team will regularly check your eyes and vision to see if there are any changes in your drusen or how well you can see. The total duration of your active participation, including check-ups after the treatment cycles, will be explained fully by the study team.

Potential risks and benefits

Participating in research always has potential benefits and risks. You might benefit if the light treatment proves effective in improving your vision or reducing drusen, though there's no guarantee the treatment will work for you. By taking part, you'll also be contributing valuable information that could help others with dry AMD in the future. As for risks, the light therapy is generally considered low risk, but specific potential side effects or discomforts will be fully explained by the study team. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Paris
Verified postcode
Paris, France· Recruiting
Università degli Studi di Ferrara
Verified postcode
Ferrara, Italy· Recruiting
Università degli studi della Campania Luigi Vanvitelli
Verified postcode
Naples, Italy· Recruiting
Università di Torino
Verified postcode
Torino, Italy· Recruiting
University of Ankara
Verified postcode
Ankara, Turkey (Türkiye)· Recruiting
Koç University Hospital
Verified postcode
Koç, Turkey (Türkiye)· Recruiting
Earlam and Christopher
Verified postcode
Taunton, United Kingdom· Recruiting

Common questions

What is dry AMD?

Dry AMD (Age-related Macular Degeneration) is an eye condition that affects the central part of your vision, making tasks like reading or recognising faces harder. It's caused by tiny deposits and thinning of cells in the 'macula' at the back of your eye.

What is photobiomodulation?

Photobiomodulation is a treatment that uses specific types of light, in this case yellow and red light, to stimulate cells and help them work better. Researchers are exploring if it can help eye cells in people with dry AMD.

Will I know if I'm getting the real treatment?

No, you won't know whether you're getting the active light treatment or a 'sham' (dummy) treatment. This is a standard way to test new treatments fairly, ensuring results aren't affected by what people expect.

How long will the treatment sessions last?

Each treatment session involves phases of continuous and pulsed yellow and red light, lasting a total of around 12 minutes of active light exposure, plus time for preparation.

Can this treatment cure my dry AMD?

This is a research study to see if the treatment is effective. There is currently no cure for dry AMD, but treatments like this might help manage the condition or improve vision. The study aims to find out more.

How to find out more

Giuseppe Giannaccare

giuseppe.giannaccare@unicz.it 003909613647135 Official trial record

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