A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

To join this study, you need to be at least 18 years old and have either type 1 or type 2 diabetes. Your diabetes should be well-managed, meaning your HbA1c (a blood test for average blood sugar) should be 12% or lower. The doctors in the study must also agree that your vision problems are mainly caused by diabetic macular oedema (DME).

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, you cannot take part. If you've had certain eye surgeries recently, such as cataract surgery or some glaucoma procedures within the last three months, you might not be eligible. Also, if you are taking certain medicines that can harm the retina, or if you've had specific eye injections within the last 3-4 months, you wouldn't be able to participate. The study team will review all your medical information carefully to see if you're a good fit.

If you decide to take part in this study, you will be assigned to one of three treatment groups by chance (like flipping a coin). You have an equal chance of receiving a lower dose of the new medicine (EYE103), a higher dose of EYE103, or the standard treatment (ranibizumab). Over the first year, you will receive treatment injections into your eye every four weeks. After the first year, the timing of your treatments might change based on how your eye responds, following a personalised plan.

You will have regular check-ups every four weeks for two years. These check-ups will include various eye tests, such as checking your vision, looking at the front and back of your eye with special lights, and taking detailed scans of the inside of your eye to measure any swelling. These appointments help the doctors understand how the treatment is working and make sure you are safe. All study-related care and medication will be provided at no cost, and you can withdraw from the study at any time.