A Phase 2, Double-Masked, Placebo-Controlled, Dose Range Finding Study of Danicopan (ALXN2040) in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
This research study is testing a new medicine called Danicopan for people with a common eye condition called geographic atrophy (GA), which is a late stage of age-related macular degeneration (AMD). GA causes blind spots to grow in your vision. The study aims to find out if Danicopan can help slow down the size of these blind spots over about a year and if it's safe to use. Some participants will receive the active medicine, while others will receive a dummy treatment (placebo) to compare the results fairly. Researchers will regularly check participants' vision and eye health using special scans to see how the medicine might be working. This is a crucial step in trying to find new ways to treat GA.
At a glance
What is this study about?
This research study is about a new medicine called Danicopan (also known as ALXN2040) for a specific eye condition called geographic atrophy (GA). GA is a long-term problem that affects your central vision and is a late stage of age-related macular degeneration (AMD). With GA, you develop blind spots in your vision that can get bigger over time.
The main goal of this study is to see if Danicopan can help slow down the growth of these blind spots in people with GA. Researchers will be looking at how the size of these blind spots changes over about a year. They also want to understand if different amounts of the medicine have different effects and if it is safe for people to use.
This is a 'Phase 2' study, which means it’s an early but important step in testing new medicines. It helps researchers gather more information about how effective a new treatment might be and what side effects it could have, before it can be used more widely. Finding new treatments for GA is really important because it can significantly affect people's quality of life.
Key takeaways
- This study is testing a new medicine for geographic atrophy (GA), a severe form of AMD.
- It aims to see if the medicine can slow down the growth of blind spots in vision.
- Participants will receive either the new medicine or a dummy treatment (placebo).
- The study involves regular eye checks and vision tests over about two years.
- Anyone 18 years or older, male or female, may be eligible.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you must be 18 years old or older. There is no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to take part in this research.
Specific medical details about your eye condition, including the type and severity of your geographic atrophy and overall health, will be carefully checked by the study doctors. This is to make sure the study medicine is right for you and that you can safely participate.
Before you can join, the study team will ask you a series of questions and conduct examinations to confirm you meet all the requirements. This ensures the study is suitable for you and helps keep you safe throughout the 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)?
- Are you able to attend regular clinic visits for about two years?
- Are you willing to have eye scans, vision tests, and blood tests?
- Do you understand you might receive a placebo (dummy treatment)?
What does participation involve?
If you decide to join this study, you would receive either the new medicine (Danicopan) or a dummy treatment (placebo); neither you nor your study doctor will know which one you are getting. You would have regular visits to the clinic for about one to two years. These visits will involve various eye checks, including special scans of your eyes (like FAF and SD-OCT) to measure your geographic atrophy and monitor your eye health. You will also have your vision tested using different charts to see if there are any changes in your eyesight or reading ability. Blood tests will be taken to check the levels of the study medicine in your body and to monitor your general health. The total duration of your participation would be around two years, with follow-up appointments extending over this period.
Potential risks and benefits
Locations (8)
- —UnverifiedSlovakia
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedHungary
- —UnverifiedItaly
- —UnverifiedCzechia
- —UnverifiedLatvia
Common questions
What is geographic atrophy (GA)?
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD), an eye condition that can cause blurred vision or blind spots in the centre of your sight.
What is a 'placebo' in a study?
A placebo is a dummy treatment that looks exactly like the real medicine but contains no active ingredients. It helps researchers compare the effects of the new medicine accurately.
How long will I be in the study?
If you join, your participation in the study will last for about two years.
Will I know if I'm getting the real medicine?
No, this is a 'double-masked' study, meaning neither you nor your study doctor will know whether you are receiving the active medicine or the placebo.
What kind of eye tests will I have?
You'll have regular eye scans and vision tests, including checking your sight with eye charts and your reading speed, to monitor your eye health and vision changes.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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