A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Aflibercept, Compared with Aflibercept Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD)
This research study is looking at a new medication, OPT-302, for 'wet' Age-related Macular Degeneration, also known as nAMD. This condition affects your central vision. The study aims to find out if using OPT-302 in combination with an already approved treatment called Eylea is more effective than using Eylea by itself. To do this, some participants will receive both treatments, while others will receive Eylea and a 'dummy' injection (a needle stick without medication, just like the OPT-302 injection would feel). The main goal is to see if participants have improved eyesight after 52 weeks (about a year). Researchers will also check other improvements, like how many people gain significant vision and changes within the eye. This is a Phase 3 study, meaning it's a large, final step before a new treatment might be approved for wider use.
At a glance
What is this study about?
This study is particularly important for people living with 'wet' Age-related Macular Degeneration (nAMD). This eye condition can lead to blurry central vision or even blind spots, making everyday tasks difficult. Currently, treatments like Eylea help many people by slowing down the process of vision loss and sometimes improving sight. However, there's always a need to find even better ways to help patients.
This research introduces a new medication called OPT-302. The idea behind this study is to see if adding OPT-302 to the standard Eylea treatment can offer a significant boost in vision improvement. Think of it like taking a well-known medicine for a problem, and then also trying a second medicine that might make the first one work even better. The study is designed to be very thorough, using a 'double-masked' approach, which means neither you nor your study doctor will know which treatment you are receiving. This helps ensure the results are as unbiased and accurate as possible.
The main thing doctors will be looking for is how much your vision changes over 52 weeks, specifically how many letters you can read on an eye chart. They will also look at other important details, like how stable your vision is, if there's less swelling or fluid in your eye, and overall safety. If OPT-302 proves to be safe and effective when combined with Eylea, it could offer a new and improved treatment option for thousands of people with 'wet' AMD.
Key takeaways
- This study evaluates a potential new drug, OPT-302, for 'wet' AMD.
- It combines OPT-302 with a standard treatment, Eylea.
- The main goal is to see if vision improves over 52 weeks compared to Eylea alone.
- It's a large, important 'Phase 3' study.
- Participation involves regular eye injections and eye tests.
- It's designed to be fair and unbiased ('double-masked').
Who may be eligible?
To join this study, you need to be at least 18 years old – there's no upper age limit. Both men and women are welcome to participate. The study is specifically for individuals diagnosed with 'wet' Age-related Macular Degeneration (nAMD).
Additionally, there will be certain medical criteria that your eye doctor will need to check against your specific health history. For example, they'll look at the current state of your eye condition, any other health problems you might have, and medications you are taking, to make sure this study is a safe and suitable option for you.
It's important to have a thorough discussion with your eye-care specialist or the study team to understand all the specific requirements and to determine if you are eligible to take part.
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 (nAMD)?
- Are you able to attend regular clinic appointments for about a year?
- Are you generally in good health other than your eye condition (as determined by a doctor)?
What does participation involve?
If you decide to take part in this study, you would primarily receive regular eye injections directly into your eye, as is standard practice for treating 'wet' AMD. You would either receive injections of Eylea along with OPT-302, or injections of Eylea along with a 'sham' injection. A sham injection means you'd experience the feeling of the injection (a needle stick) without any medication being delivered, which helps ensure no one knows which treatment group you are in.
You would have regular visits to the clinic for these injections and for various eye tests. These tests include standard eye exams, vision tests where you read letters on a chart, and special photographs of your eye to check its health. The study will last for a total of 52 weeks, which is about one year, during which you'll have scheduled appointments for monitoring your vision and eye health.
Potential risks and benefits
Locations (16)
- —UnverifiedCzechia
- —UnverifiedBulgaria
- —UnverifiedCroatia
- —UnverifiedNetherlands
- —UnverifiedPoland
- —UnverifiedEstonia
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedSlovakia
- —UnverifiedAustria
- —UnverifiedLithuania
Common questions
What is 'wet' Age-related Macular Degeneration (nAMD)?
It's an eye condition where abnormal blood vessels grow under the central part of your retina (the macula), leaking fluid and blood, which can seriously affect your central vision.
What is Eylea?
Eylea is a common and approved medication for 'wet' AMD. It's an injection given into the eye that helps stop the growth of abnormal blood vessels.
What is a 'sham' injection?
A sham injection means you'll feel a needle prick, just like a real injection, but no medicine is given. This helps ensure the study results are fair by keeping everyone 'blinded' to who gets the active drug.
How long will the study last?
The study will last for 52 weeks, which is about one year, with regular clinic visits during that time.
Will I know if I'm getting the new drug?
No, this is a 'double-masked' study, meaning neither you nor your study doctor will know whether you are receiving OPT-302 or the sham injection alongside Eylea.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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