This clinical study is looking at how well a special eye implant called the Port Delivery System (PDS) with the medicine ranibizumab works for people with Diabetic Macular Edema (DME). DME is a condition where the part of your eye called the macula gets thick and can affect your vision. The study is comparing two ways to get the medicine: through the PDS implant every 24 weeks or regular eye injections every 4 weeks.
There's also a substudy focusing on the safety of putting in a new version of the PDS for some people who were in the first study. Up to 100 people will be followed for up to 72 weeks after getting the new implant. You need to be 18 or older and have diabetes to join. There are some health conditions that might prevent you from participating, like certain eye conditions, recent surgeries, or other health issues.
- Participation involves regular check-ups over 72 weeks for some participants.
- Safety and effectiveness of the implant are key study points.
- Participants may experience some risks related to the implant and medical procedures.