A Phase II/III Multicenter, Randomized, Masked, Active Comparator-Controlled Study to Evaluate the Safety and Efficacy of Two Doses of OCUL101, an Anti-VEGF and Anti-Complement C5, Bi-specific Humanized Antibody-Like “trap” in Participants with Neovascular Age-Related Macular Degeneration with or without Geographic Atrophy – STAT Study
Age-related macular degeneration (AMD) affects the central part of your vision, which you need for reading and recognising faces. In the 'wet' form, tiny abnormal blood vessels leak fluid into the back of the eye, causing sudden sight changes. This clinical trial is testing a new medicine called OCUL101. It targets two separate causes of swelling and damage at once. Researchers are comparing two different doses of OCUL101 against an existing, widely used eye medicine called Eylea (aflibercept). The trial is split into two parts: Part A checks how safe the medicine is, while Part B tests how well it improves or preserves your vision over 36 weeks and beyond. Taking part involves receiving regular eye injections and having detailed eye scans over up to 96 weeks to track your eye health.
At a glance
What is this study about?
Age-related macular degeneration (AMD) is a common eye condition that affects older adults. The 'wet' type happens when fragile blood vessels grow underneath the macula—the sensitive centre of the retina. These vessels can leak fluid and blood, causing blurred or distorted vision. Current standard treatments use regular injections into the eye to stop these vessels from leaking, but scientists are searching for medicines that work better or last longer.
This study, called the STAT study, is looking at an experimental medicine called OCUL101. Unlike older medicines that only block one pathway, OCUL101 is designed to block two different signals linked to inflammation and blood vessel growth. Doctors hope this dual approach might protect your sight more effectively, even if you also have areas of dry retinal wear and tear known as geographic atrophy.
In the study, participants will receive either the new drug (OCUL101) or a proven standard treatment called Eylea. Neither you nor your study doctor will choose which treatment you receive; this is decided randomly by a computer to ensure fair results. The main goal is to measure how many letters you can read on an eye chart after several months of treatment, while closely checking for any unwanted side effects.
Key takeaways
- Tests a new medicine (OCUL101) designed to target two causes of wet AMD.
- Compares the new drug directly against a proven standard treatment (Eylea).
- All participants receive an active treatment; there is no dummy injection.
- Participation involves regular clinic visits, eye scans, and injections over up to 96 weeks.
- Taking part is entirely voluntary, and you can stop at any time.
Who may be eligible?
This trial is open to adults of any age and sex who have been diagnosed with neovascular (wet) age-related macular degeneration. People who have dry patches alongside wet AMD (known as geographic atrophy) may also be considered.
To join, you must have active leakage in the affected eye that requires treatment. The trial doctors will perform an initial screening examination to look closely at the back of your eye and see if this study is medically suitable for you.
You might not be eligible if you have certain other eye conditions, such as advanced glaucoma, severe eye infections, or if you have recently had specific eye surgeries. Your general health will also be taken into account to ensure it is safe for you 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.
- I have been diagnosed with wet (neovascular) age-related macular degeneration.
- I am able and willing to attend regular hospital or clinic appointments for up to two years.
- I am comfortable receiving regular eye injections and having detailed eye scans.
- I do not have an active eye infection or uncontrolled eye pressure (glaucoma).
What does participation involve?
Taking part in this study lasts up to 96 weeks (just under two years). You will need to visit an eye clinic regularly. At these visits, your eye team will check your sight using letter charts, measure the pressure in your eye, and take detailed pictures and scans of your retina (such as OCT scans). You will receive your allocated medicine as an injection directly into the eye. The clinic team will use numbing drops and antiseptic washes to make the injection as quick and comfortable as possible. Afterwards, you will be monitored for a short time before going home, and you will have follow-up visits to check how your eye is healing.
Potential risks and benefits
Locations (4)
- —UnverifiedLatvia
- —UnverifiedPoland
- —UnverifiedCzechia
- —UnverifiedHungary
Common questions
Will having an eye injection hurt?
The clinical team will use numbing drops to ensure you feel as little discomfort as possible. Most patients report feeling slight pressure rather than sharp pain.
Can I choose which treatment I receive?
No. A computer randomly decides whether you receive the new medicine (OCUL101) or the standard treatment (Eylea) so the results remain fair and unbiased.
Will I receive a dummy treatment (placebo)?
No. Everyone in this study receives an active medication—either the new medicine being tested or an already approved treatment.
How long will I be in the study?
Your participation could last for up to 96 weeks (nearly two years), involving regular check-ups and treatments at the clinic.
Can I leave the study if I change my mind?
Yes. You can leave the trial at any point without giving a reason, and your usual healthcare will continue as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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