The aim of this study is to find out whether an experimental study medication can help prevent vision loss and worsening of symptoms in people with non-proliferative diabetic retinopathy (NPDR). The experimental study medication will be compared with a ‘dummy treatment’. A ‘dummy treatment’ is designed to seem the same as an experimental study treatment but contains no medicine.
Approximately 175 people across North America, Europe and Asia are expected to take part.
If you take part, you will be allocated at random (like pulling a number out of a hat) to 1 of 4 groups of study participants. Three of these groups will be given the experimental study medication at different times during the study and 1 group will receive the dummy treatment.
You cannot choose which group you will join.
You will be randomly allocated to 1 of 5 study groups. Participants in three of these groups will be given the experimental study medication, 1 group of participants will receive the dummy treatment and 1 group will receive a drug called Eylea®. Eylea® is approved in the USA for the treatment of diabetic retinopathy, including NPDR.
The experimental study medication will be injected into the gel-like substance inside the eye (called the vitreous) by an experienced member of the study team. Your eye will be checked following the injection to ensure there are no immediate side effects.
The dummy treatment follows the same steps as the experimental study medication injection but uses a syringe without a needle, so no experimental study medication will be injected into the eye.
The study could last up to 18 months (a year and a half). It is composed of 3 parts:
- Part 1: Screening – you will undergo some tests to see if you are right for the study and the study is right for you.
- Part 2: Study treatment – you will receive the experimental study medication or dummy treatment every 4 weeks for 24 weeks. The dosing frequency will then extend to every 8 weeks until Week 40, and then return to every 4 weeks until Week 48.
- Part 3: Follow-up – 4, 12 and 20 weeks after you receive the last dose of experimental study medication or dummy treatment you will return to the study centre to check on your health.
You will be asked to attend around 17 visits to the study centre throughout the study to have some medical tests and assessments.
No medication is completely safe. One of the aims of this study is to find out whether the experimental study medication causes side effects. If you experience any discomfort during the study, you can contact the study team at any time – they are there to help, and to ensure your safety at all times.