MacuTherm Performance Study in Patients With iAMD
This research study is investigating a new type of light treatment called photothermal therapy for people experiencing intermediate Age-related Macular Degeneration (iAMD). The main goal is to see if this special treatment, delivered by a Navilas® Laser System, can help keep the light-sensing cells in the eye (photoreceptors) healthier for longer. Protecting these cells is important because iAMD can lead to vision loss. Researchers will compare this treatment to a 'sham' treatment (a pretend treatment) to understand its effectiveness. They hope to show that this therapy can reduce how quickly iAMD progresses and preserve important vision cells, potentially improving patients' lives by helping them maintain their sight.
At a glance
What is this study about?
This study is looking into a new way to treat intermediate Age-related Macular Degeneration, often called iAMD. iAMD is an eye condition that can affect your central vision, making it harder to see details, read, or recognise faces. It happens when parts of your retina, at the back of your eye, don't work as well as they should.
The researchers want to test a special light treatment called photothermal therapy. This therapy uses a gentle laser to target specific areas in your eye. The hope is that this treatment will help to protect the vital cells in your eye (called photoreceptors) that are responsible for your vision. By keeping these cells healthier, the study aims to slow down the progression of iAMD and help preserve your eyesight for longer.
To find out if this treatment works, some participants will receive the active treatment, while others will have a 'sham' treatment, which looks and feels similar but isn't the real therapy. This is a common and important way to fairly test new treatments. The study will carefully monitor changes in your eye and your vision over two years to see if the photothermal therapy makes a positive difference.
Key takeaways
- This study is testing a new light treatment for intermediate AMD.
- It aims to protect vision cells and potentially slow down AMD progression.
- Participation involves regular clinic visits over two years.
- You might receive the active treatment or a 'sham' treatment.
- Eligibility depends on specific eye conditions and age.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you would need to be between 60 and 90 years old and have a confirmed diagnosis of intermediate Age-related Macular Degeneration (iAMD). Your eye doctor would need to see specific features in your eye, such as a certain number of drusen (small yellowish deposits) and possibly other signs like changes in your retina.
Your vision also needs to be within a certain range – not too poor, and not too good. You should also be able to understand what the study involves and be happy to take part, giving your written consent. You shouldn't have any other serious eye conditions that could affect the results of the study.
People who have advanced forms of AMD, like wet AMD or geographic atrophy, or have had recent eye surgery (within the last 6 months, except for uncomplicated cataract surgery more than 3 months ago) would not be able to join. Also, if you're pregnant or breastfeeding, or are taking part in another drug or device study, you wouldn't be eligible.
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 between 60 and 90 years old?
- Have you been diagnosed with intermediate AMD by an eye doctor?
- Do you have certain signs in your eye, like at least 3 large drusen?
- Is your vision within a specific range (not too bad, not too good)?
- Have you had recent eye surgery (other than uncomplicated cataracts over 3 months ago)?
- Are you able to attend appointments for two years?
What does participation involve?
If you join this study, you'll be randomly put into one of two groups: either the group receiving the photothermal therapy or the group receiving the 'sham' treatment. This means you won't get to choose which group you're in.
Over two years, you will need to attend 12 visits to the study clinic. In the first three months, these visits will be monthly. After that, they will be every three months until the study ends. During these visits, the study team will carry out various eye checks and assessments to see how your eyes are responding to the assigned treatment.
Potential risks and benefits
Locations (4)
- Department of Ophthalmology at Hannover Medical SchoolVerified postcodeHanover, Germany· Not yet recruiting
- Department of Ophthalmology, University Medical Center Schleswig-HolsteinVerified postcodeLübeck, Germany· Not yet recruiting
- Potsdam Eye Clinic at GräfehausVerified postcodePotsdam, Germany· Not yet recruiting
- AugenNord Medical Practice and Surgical CenterVerified postcodeSchleswig, Germany· Recruiting
Common questions
What is iAMD?
Intermediate Age-related Macular Degeneration (iAMD) is an eye condition that affects the central part of your vision, called the macula. It can make it harder to see details clearly.
What is photothermal therapy?
It's a special light-based treatment that uses a gentle laser to target specific areas in your eye. It's hoped to help protect your vision cells.
Will I get the actual treatment or a pretend one?
You will be randomly assigned to either receive the active photothermal therapy or a 'sham' (pretend) treatment. You won't be able to choose.
How long will the study last?
The study will last for a total of two years, with a number of clinic visits during that time.
Can I leave the study if I change my mind?
Yes, you have the right to withdraw from the study at any point, and it won't affect your regular medical care.
How to find out more
Jan Tode, Prof. Dr. med.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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