A Phase 2, Randomized, Masked, Placebo-Controlled Study of Subcutaneously Administered ADX-038 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
This is a research study for people with an eye condition called geographic atrophy (GA), which is an advanced form of age-related macular degeneration (AMD). GA can cause blurry vision or blind spots. In this study, doctors are testing a new medicine called ADX-038. They want to find out if this medicine, given as a shot under the skin, can help slow down the worsening of GA compared to a dummy treatment (placebo). The study is in its second phase, meaning it's still relatively early in testing. Researchers will carefully measure how the GA area in the eye changes over time to see if ADX-038 makes a difference.
At a glance
What is this study about?
This study is about a new possible treatment for an eye condition called geographic atrophy (GA). GA is a serious form of age-related macular degeneration (AMD) that can lead to permanent blurry spots or loss of vision, especially in the centre of your eyesight, making it hard to read or recognise faces. Currently, there aren't many treatments that can stop GA from getting worse, so finding new options is very important.
The new treatment being tested is called ADX-038. In this study, some people will receive ADX-038, while others will receive a 'placebo', which looks like the real treatment but contains no active medicine. This helps researchers fairly compare the new treatment's effects. The medicine is given as a shot under the skin.
The main goal of the study is to see if ADX-038 can slow down the growth of the GA area in the eye over a year. They will also look at how GA changes over two years and check if the treatment affects your overall vision. This research is part of a therapeutic exploratory (Phase II) study, meaning it's aimed at finding out if the treatment works and is safe before it can be offered more widely.
Key takeaways
- This study is testing a new medicine called ADX-038 for geographic atrophy (GA).
- GA is a serious eye condition that can cause central vision loss.
- The treatment is given as a shot under the skin.
- Participants will either receive the new medicine or a dummy treatment (placebo).
- The study aims to see if ADX-038 can slow down the progression of GA.
- It's a Phase II study, meaning it's still an early stage of testing.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. Both men and women can take part.
You must have been diagnosed with geographic atrophy (GA) because of age-related macular degeneration (AMD) in at least one of your eyes.
The study team will have specific medical checks to make sure your GA is at a stage that can be studied and that you are generally healthy enough to participate safely. They will also check your current vision and other eye health details.
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?
- Have you been diagnosed with geographic atrophy (GA) due to age-related macular degeneration (AMD)?
- Are you able to attend regular clinic appointments for up to two years?
- Are you generally in good health apart from your eye condition?
What does participation involve?
If you decide to take part, you will be assigned to either receive the new medicine, ADX-038, or a placebo (a dummy treatment). You won't know which one you are getting, and neither will your study doctor, this is known as 'masking'. The medicine or placebo will be given as a shot under the skin.
You will need to attend regular appointments at the clinic for eye examinations, including special photographs of your eye (FAF and OCT scans), and general health checks. These visits will help the doctors monitor your eye condition and overall health. The study plans to follow people for up to two years to see the long-term effects of the treatment.
Potential risks and benefits
Locations (4)
- —UnverifiedGermany
- —UnverifiedPortugal
- —UnverifiedItaly
- —UnverifiedSpain
Common questions
What is Geographic Atrophy (GA)?
GA is an advanced form of age-related macular degeneration (AMD) where cells in part of the eye die off, leading to blurry or missing spots in your central vision.
What is ADX-038?
ADX-038 is a new medicine being tested to see if it can help slow down the worsening of geographic atrophy.
How will I receive the treatment?
The treatment will be given as a shot under the skin, similar to some other common injections.
What is a 'placebo'?
A placebo looks just like the study medicine but doesn't contain any active drug. It helps researchers compare the new treatment fairly.
How long will I be in the study?
The study plans to follow participants for up to two years to see the effects of the treatment over time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.