A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema

To join this study, you need to be an adult aged 18 or over and have been diagnosed with diabetes (type 1 or type 2). Your diabetes should be well-managed with stable medication, and you shouldn't have plans for major changes to your diabetes treatment soon.

Crucially, you must have a specific type of diabetic macular edema, called 'centre-involved DME,' which means the central part of your vision is affected. This will be confirmed by eye scans. Your vision in the affected eye must also fall within a certain range.

There are also some reasons why you wouldn't be able to join. For example, if your macular edema is due to other causes, or if you have a more severe form of diabetic eye disease called proliferative diabetic retinopathy. If you've had certain eye treatments recently, such as injections into the eye or eye surgery, or even some eye drops, you might not be able to participate. The medical team will review all your health information carefully to see if this study is suitable for you.

If you decide to take part, you will be in the study for about one year. During this time, you will take tablets twice a day for approximately 11 months. You’ll be asked to visit the study clinic 16 times during the year. At these visits, doctors and nurses will carefully check your vision and overall eye health. They will also take detailed pictures of your eye. You’ll be asked about any new health problems you experience, and these will be recorded. All this information helps the researchers understand how the treatment is working and monitor your safety. After your last dose of medication, there will be follow-up appointments to check your health and eye condition.