A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will be Determined at Week 56
The LUCIA study is a two-year clinical trial investigating a new treatment called EYP-1901 for wet age-related macular degeneration (wAMD). This condition affects the central vision. The study aims to compare EYP-1901 against an existing, commonly used treatment called aflibercept (2.0 mg). Participants will be randomly assigned to receive either the new treatment or the standard one, and neither they nor their doctors will know which treatment they are getting. The main goal is to find out how well EYP-1901 works after 56 weeks by looking at how it affects vision. The study is in its Phase 3, meaning it's a large-scale trial to confirm the safety and effectiveness of the new treatment.
At a glance
What is this study about?
This clinical trial, known as LUCIA, is focused on finding new and effective ways to manage wet age-related macular degeneration (wAMD). wAMD is a common eye condition that can cause blurred vision or blind spots, particularly in the centre of your sight. It happens when abnormal blood vessels grow under the retina, leaking fluid or blood and damaging the macula, which is the part of the eye responsible for sharp, detailed vision.
The study is comparing a new treatment called EYP-1901 with a widely used, established treatment called aflibercept. Aflibercept is given as an injection into the eye and works by blocking a protein that encourages abnormal blood vessel growth. Researchers want to see if EYP-1901 can offer similar benefits to aflibercept, potentially providing patients with another treatment option. This is a "Phase 3" trial, which is a crucial stage where a new treatment is tested on a larger group of people to confirm its effectiveness and safety before it can be considered for wider use.
The main aim over the two years is to see how well EYP-1901 performs in maintaining or improving vision compared to aflibercept, with the first key assessment happening at 56 weeks into the study. Finding alternative or improved treatments for wAMD is important because it could lead to better outcomes for patients and potentially reduce the frequency of treatments needed, which can be a significant burden.
Key takeaways
- This study is testing a new treatment (EYP-1901) for wet AMD.
- It compares the new treatment against a standard one (aflibercept).
- It's a two-year study to see how well the new treatment works for vision.
- Participation involves regular eye checks and injections into the eye.
- You can withdraw from the study at any time.
- The study is for people aged 50 and over with wAMD.
Who may be eligible?
To join this study, you must have been diagnosed with wet age-related macular degeneration (wAMD) in at least one eye, which we call the 'study eye'. Your vision in this study eye, when tested, should fall within a specific range – not too good, but not severely poor either (roughly equivalent to being able to read between the third and seventh line from the top on a standard eye chart).
If you've had treatment for wAMD before, you need to have received at least two anti-VEGF injections (like aflibercept, ranibizumab, or similar drugs) in your study eye in the six months leading up to the start of the study. This shows that your wAMD is active and responsive to treatment. Your doctors will check all your medical records to confirm this.
There are also some reasons why you might not be able to join. For example, if you have significant scarring, severe thinning, or complete loss of tissue in the central part of your study eye. Also, if your vision in your *other* eye (the one not being studied) is very poor – worse than being able to read the very top letter on a standard eye chart – you would not be able to take part. The study is open to both men and women, aged 50 years and older.
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 50 years of age or older?
- Have you been diagnosed with wet AMD in at least one eye?
- Is your vision in your 'study eye' within a specific range (not too good, not too poor)?
- If you've had previous wet AMD treatment, have you received at least two eye injections in the last 6 months?
- Do you *not* have severe scarring or tissue loss in the centre of your eye?
- Is your vision in your *other* eye (the non-study eye) not severely impaired?
What does participation involve?
If you decide to take part in this study, you would first undergo a screening process to check if you meet all the requirements. If eligible, you would be randomly assigned to one of two groups: one receiving the new treatment (EYP-1901) and the other receiving the standard treatment (aflibercept). Neither you nor your study doctor would know which treatment you are receiving until the study is over.
You would have regular visits to the clinic over a two-year period. These visits would involve detailed eye examinations, including checks of your vision, scans of your eye, and possibly other tests to monitor your condition and how you are responding to the treatment. The medication would be given through injections into your eye, as is common with wAMD treatments. You would also have check-ups to monitor your general health. The research team will explain the full schedule of visits, assessments, and follow-up care, ensuring you understand everything involved.
Potential risks and benefits
Locations (125)
- Associated Retina ConsultansVerified postcodeGilbert, United States
- Associated Retina Consultants - PhoenixVerified postcodePhoenix, United States
- Phoenix Retina Clinical Trials, LLCVerified postcodePhoenix, United States
- Retina Macula Institute of ArizonaVerified postcodeScottsdale, United States
- Win RetinaVerified postcodeArcadia, United States
- Doctor Retina, PCVerified postcodeBeverly Hills, United States
- The Retina PartnersVerified postcodeEncino, United States
- RCOC Clinical Research Institute Inc.Verified postcodeFullerton, United States
- Global Research Management, Inc.Verified postcodeGlendale, United States
- Atlantis EyecareVerified postcodeHuntington Beach, United States
- South Coast Retina CenterVerified postcodeLong Beach, United States
- Retinal Consultants Medical GroupVerified postcodeModesto, United States
Common questions
What is wet age-related macular degeneration (wAMD)?
wAMD is an eye condition that affects the central part of your vision, called the macula. It's caused by abnormal blood vessels growing under the retina that leak, leading to blurred vision or blind spots.
What does 'Phase 3 randomized, double-masked study' mean?
Phase 3 means it's a large trial testing a new medicine's safety and effectiveness. 'Randomized' means you'll be put into a treatment group by chance. 'Double-masked' means neither you nor your doctor will know which treatment you're receiving.
What is the new treatment, EYP-1901?
EYP-1901 is a new treatment being investigated for wAMD. The study aims to see if it works as well as, or better than, current standard treatments like aflibercept.
What is aflibercept (2.0 mg)?
Aflibercept is a common and established medicine used to treat wAMD. It's given as an injection into the eye and helps to stop the growth of abnormal blood vessels that cause vision loss.
How long will the study last?
The study is planned to last for two years. Your participation would involve regular clinic visits over this period.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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