A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
This research study is looking into a new treatment, JNJ-81201887, for a common eye condition called Geographic Atrophy (GA). GA is a severe form of Age-related Macular Degeneration (AMD) that happens when parts of your retina, at the back of your eye, wear away. This can lead to blind spots and serious vision loss. The study aims to find out if JNJ-81201887, which is given as an injection into the eye, can help slow down the progress of GA. Participants will be compared to a group receiving a sham (dummy) procedure, which is like a fake treatment, to see if the new drug really makes a difference. Scientists will measure changes in the size of the areas affected by GA in the eye.
At a glance
What is this study about?
This study is a research project focused on a new potential treatment for Geographic Atrophy (GA). GA is an advanced form of Age-related Macular Degeneration (AMD), a common eye condition that affects older people. In GA, special cells in the back of your eye, called the macula, that help you see clearly, start to break down. This can lead to gradual loss of central vision, making it hard to read, recognise faces, or drive. There are currently limited treatments available for GA, so finding new ways to slow down or stop its progression is really important.
The new treatment being tested is called JNJ-81201887. It's designed to be given as an injection directly into the eye. This study is in 'Phase 2b', which means researchers are trying to find the best dose of the treatment and further check how safe and effective it is. They will compare it to a 'sham procedure', which looks and feels like the real treatment but doesn't involve the actual drug. This helps scientists truly understand if any improvements are due to the treatment itself rather than other factors.
The main goal is to see if JNJ-81201887 can slow down the growth of the damaged areas in the eye caused by GA. To do this, doctors will take special pictures of the back of the eye, called fundus autofluorescence (FAF), to measure the size of these affected areas before, during, and after the treatment. Understanding if this new approach can protect your vision is a key step towards better treatments for GA.
Key takeaways
- New eye treatment (JNJ-81201887) for Geographic Atrophy (GA) is being tested.
- GA is a severe eye condition causing central vision loss, common in older adults.
- Treatment involves injections into the eye.
- Study compares the new treatment to a ‘sham’ (dummy) procedure.
- Main goal: see if it slows down GA progression.
- Participants will have regular eye exams and health checks.
Who may be eligible?
This study is looking for adults aged 18 and over, of any gender. People who take part must have been diagnosed with Geographic Atrophy (GA) due to Age-related Macular Degeneration (AMD) in at least one eye.
To be considered, there are several health checks and eye examinations you would need to pass to make sure the study treatment is safe for you and that the results of the study will be clear. For example, certain other eye conditions or serious health problems might prevent you from joining.
If you are interested, a study doctor will carefully review your full medical history and perform a thorough eye exam to confirm if you meet all the specific requirements needed for this research.
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 18 years old or older?
- Do you have a diagnosis of Geographic Atrophy (GA) in at least one eye?
- Are you able to attend regular clinic appointments?
- Do you understand that you might receive a placebo (dummy treatment)?
What does participation involve?
If you decide to take part, you would receive the study treatment (either JNJ-81201887 or the sham procedure) directly into your eye at regular intervals over the course of the study. You would also receive other standard medications, like small tablet doses of cortisone (Prednisone) or an injection of Kenacort, which are often used to help manage inflammation.
Regular visits to the clinic would be essential. These visits would involve detailed eye examinations, including the special eye photographs (FAF scans) to measure your GA, and other general health checks to monitor your safety and how your eyes are responding. The total duration of your participation in this study would be decided by the researchers, but clinical trials usually last for a number of months, or even a couple of years, to see the full effect of a treatment and its long-term safety.
Potential risks and benefits
Locations (11)
- —UnverifiedNetherlands
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedPortugal
- —UnverifiedSweden
- —UnverifiedHungary
- —UnverifiedPoland
- —UnverifiedDenmark
- —UnverifiedCzechia
- —UnverifiedSpain
Common questions
What is Geographic Atrophy (GA)?
Geographic Atrophy is a severe form of Age-related Macular Degeneration (AMD) where specific cells in the central part of your vision (the macula) waste away, leading to blind spots and vision loss.
What does 'intravitreal' mean?
Intravitreal means 'inside the eye'. The study treatment is given as an injection directly into the jelly-like substance in the centre of your eye.
What is a 'sham procedure'?
A sham procedure is like a dummy treatment. It looks and feels similar to the actual treatment, but no active drug is given. This helps researchers compare the real drug's effects accurately.
Will I know if I'm getting the real treatment or the sham?
No, this is a 'double-masked' study, meaning neither you nor the study team will know whether you are receiving the active treatment or the sham procedure. This helps ensure fair and unbiased results.
How long will the study last if I join?
The full duration of participation will be explained by the study team, but clinical trials like this typically require regular visits over several months or even a few years.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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