A Phase 3 Clinical Trial to Compare Efficacy, Safety, Tolerability and Immunogenicity of RBS-001 to Eylea® in Subjects with Neovascular Age-Related Macular Degeneration
This research study is about finding new and better ways to treat a common eye condition called wet age-related macular degeneration, or wet AMD. This condition can cause blurry vision or blind spots. We are testing a new medicine called RBS-001 and comparing it to a treatment that is already used, called Eylea. For this study, we'll be looking at how well RBS-001 helps improve your eyesight over time compared to Eylea. We'll also be carefully checking for any side effects and how well your body tolerates the new medicine. This is a large study (Phase 3), meaning it's one of the final steps before a new treatment might become widely available.
At a glance
What is this study about?
This research project is designed to investigate a new medication, RBS-001, as a potential treatment for wet age-related macular degeneration (wet AMD). Wet AMD is a common eye condition that affects the macula, the part of your eye responsible for sharp, central vision, which you use for tasks like reading and recognising faces. In wet AMD, unwanted blood vessels grow under the macula, leaking fluid and blood, which can distort vision and lead to blind spots.
The main goal of this study is to compare RBS-001 with Eylea, a medication currently used to treat wet AMD. We want to see if RBS-001 is as effective, or even more effective, at improving and preserving your eyesight. We'll also be carefully monitoring how safe the new medication is and whether participants experience any side effects. This is a 'Phase 3' study, which means it’s a later stage of research involving a larger number of people, and the results from studies like this are very important for deciding if a new medicine should be approved for general use.
Throughout the study, we will be regularly checking your vision using a standard eye chart. We'll also use special eye scans, like OCT (Optical Coherence Tomography) and FA (Fluorescein Angiography), to look at the back of your eye, monitoring things like fluid build-up and the abnormal blood vessels. All these tests help us understand how well the treatments are working and track any changes in your eye health.
Key takeaways
- This study is testing a new eye medicine, RBS-001, for wet AMD.
- It compares the new medicine to an existing treatment called Eylea.
- The main aim is to see if RBS-001 improves vision and is safe.
- Participants will have regular eye injections and many eye checks.
- The study lasts about one year and involves people aged 18 and over.
Who may be eligible?
To be able to join this study, generally, you would need to be 18 years old or older. The study is open to both men and women.
Important requirements for joining also include having been diagnosed with wet age-related macular degeneration in at least one eye. The doctors will need to check your medical history and perform a full eye exam to make sure you meet all the specific criteria for the study.
There might be other health conditions or medications that would prevent you from taking part, to ensure the study is safe for everyone involved and that the results are clear. Your study doctor will discuss all these details with you.
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 wet age-related macular degeneration (wet AMD)?
- Are you prepared for regular eye injections?
- Can you attend frequent hospital or clinic appointments for about a year?
What does participation involve?
If you decide to take part in this study, you will receive regular injections into your eye, either with the new medicine RBS-001 or with Eylea. These injections are like the ones already used for wet AMD. You will also have many follow-up appointments, especially during the first few months, to check your vision and the health of your eyes.
During these visits, you'll have various eye tests. This includes looking at eye charts to check your sharpness of vision, and eye scans (like OCT and FA) to see what's happening at the back of your eye. You might also have blood tests and general health checks. These visits will continue for up to a year, with the frequency of visits gradually reducing over time. The total duration of your participation in the study will be about 52 weeks (one year).
Potential risks and benefits
Locations (4)
- —UnverifiedBulgaria
- —UnverifiedCroatia
- —UnverifiedSlovakia
- —UnverifiedPoland
Common questions
What is wet age-related macular degeneration (wet AMD)?
Wet AMD is an eye condition where abnormal blood vessels grow in the back of your eye, leaking fluid and blood, which blurs your central vision.
What is Eylea?
Eylea is a medication already approved and used to treat wet AMD by slowing down the growth of these abnormal blood vessels.
What is a Phase 3 clinical trial?
A Phase 3 trial means the new treatment has already passed earlier safety checks and is now being compared to existing treatments in a larger group of people to confirm its effectiveness and safety.
Will I know if I'm getting RBS-001 or Eylea?
Often in these types of studies, participants don't know which treatment they are receiving (it's called 'blinded') to ensure the results are as fair and accurate as possible.
How long will I need to be in the study?
Your involvement in this study would be for approximately 52 weeks, which is about one year.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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