Phase 2 Study of ADX-038 in Participants With Geographic Atrophy
This study is investigating a new medication called ADX-038 for a common eye condition known as geographic atrophy (GA). GA is a severe form of age-related macular degeneration (AMD) that can lead to significant vision loss. In this study, we aim to find out if ADX-038 can help slow down the progression of GA compared to a placebo, which is an inactive treatment. We will also carefully check for any side effects and how the body handles the medicine. This is a Phase 2 study, meaning it's an important step in understanding if this new treatment could be a helpful option for people living with GA. It's designed to gather more information about its effectiveness and safety.
At a glance
What is this study about?
This study is focused on a condition called geographic atrophy (GA), which is a serious form of age-related macular degeneration (AMD). AMD is a common eye problem that affects the macula, the part of your eye responsible for sharp central vision. In GA, special cells in the macula slowly break down, creating 'blind spots' and leading to blurry or missing central vision. It can make everyday tasks like reading or recognising faces very difficult.
Currently, there aren't many treatments that can stop or reverse geographic atrophy. That's why researchers are studying new medications like ADX-038. This study is a 'Phase 2' trial, which means it's an important early step in testing a new medicine. We're trying to see if ADX-038 can actually slow down the progression of GA compared to a 'placebo', which is a dummy treatment like a sugar pill or an inactive injection. This helps us understand if the new treatment has a real effect.
Beyond just seeing if the treatment works, we're also very interested in its safety. We'll be carefully monitoring participants for any side effects and looking at how their bodies react to and process the medication. The goal is to gather enough information to decide if ADX-038 is promising enough to be tested in larger studies, with the ultimate hope of providing a new and effective treatment option for people with geographic atrophy.
Key takeaways
- This study is testing a new treatment (ADX-038) for geographic atrophy (GA), a severe eye condition.
- It aims to see if ADX-038 can slow down GA progression compared to a dummy treatment (placebo).
- Safety and how the body handles the medicine are also being carefully checked.
- This is an early-stage study (Phase 2), a step towards finding new GA treatments.
- Participation involves regular clinic visits, eye exams, and potentially blood tests.
- You have the right to leave the study at any time.
Who may be eligible?
To join this study, you need to have been diagnosed with geographic atrophy (GA) in your eye, and this GA must be due to age-related macular degeneration (AMD). The affected area in your eye needs to be a specific size, not too small and not too large. It's also important that your eye is clear enough for doctors to take good pictures and examine it properly, and you need to be able and willing to come to all the study appointments and follow all the instructions, including getting certain vaccinations if needed.
There are also reasons why you might not be able to join. For example, if your GA is caused by something other than AMD, or if you have other ongoing eye problems that could affect the study results or your vision. You also can't have had surgery for a detached retina or have certain other eye conditions. If you've received specific eye injections in the past to treat related conditions, or if you have certain rare immune conditions or severe liver problems, you might not be suitable. Having an active infection, donating blood, or having scars from previous bleeding in the eye would also prevent you from participating. The study is open to both men and women, aged 60 and over.
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.
- Do you have geographic atrophy (GA) in your eye caused by age-related macular degeneration (AMD)?
- Is the affected area in your eye about the right size (not too small or too large)?
- Are your eyes clear enough for doctors to take good pictures and examine them properly?
- Are you able and willing to attend all study appointments and follow instructions?
- Are you 60 years old or older?
- Have you not had certain other serious eye conditions or treatments in the eye being studied?
What does participation involve?
If you decide to take part in this study, you would receive either the new study medication, ADX-038, or a placebo (an inactive treatment). What you receive would be decided by chance, like flipping a coin. You would have regular visits to the clinic, where doctors would examine your eyes, take special pictures, and perform various tests to check your vision and the health of your eyes. They would also monitor your overall health to check how you're reacting to the treatment and for any side effects. You might also have blood tests. These visits and assessments are important for understanding how ADX-038 works and if it's safe. The full duration of your participation in the study, including all treatments and follow-up checks, would be explained to you by the study team.
Potential risks and benefits
Locations (24)
- ADARx Clinical SiteVerified postcodeGilbert, United States· Recruiting
- ADARx Clinical SiteVerified postcodePhoenix, United States· Recruiting
- ADARx Clinical SiteVerified postcodeBeverly Hills, United States· Recruiting
- ADARx Clinical SiteVerified postcodeHuntington Beach, United States· Recruiting
- ADARx Clinical SiteVerified postcodePoway, United States· Recruiting
- ADARx Clinical SiteVerified postcodeOrlando, United States· Recruiting
- ADARx Clinical SiteVerified postcodeWildwood, United States· Recruiting
- ADARx Clinical SiteVerified postcodeHagerstown, United States· Recruiting
- ADARx Clinical SiteVerified postcodeReno, United States· Recruiting
- ADARx Clinical SiteVerified postcodeErie, United States· Recruiting
- ADARx Clinical SiteVerified postcodeAustin, United States· Recruiting
- ADARx Clinical SiteVerified postcodeDallas, United States· Recruiting
Common questions
What is geographic atrophy (GA)?
Geographic atrophy is an advanced form of age-related macular degeneration (AMD) where cells in the central part of your vision slowly break down, leading to blurriness or blind spots.
What is a Phase 2 study?
A Phase 2 study is an early stage of testing a new medicine. It helps researchers find out more about how well the treatment works and if it's safe, usually in a small group of people.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers see if the actual drug has a genuine effect.
Will I know if I'm getting the active treatment or the placebo?
No, during the study, neither you nor the study doctors will know whether you are receiving ADX-038 or the placebo. This is to ensure the results are unbiased.
How long will I be in the study?
The exact length of your participation will be discussed with you by the study team, as it includes treatment periods and follow-up checks.
How to find out more
Nali Castillo
Always speak to your GP or specialist before deciding to take part in a study.
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