Image

A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Subtudy to Evaluate the Safety of Re-Implanting the PDS With Ranibizumab in Participants With DME

Study on new ranibizumab delivery system for diabetic macular edema.

Recruiting
18 years and older
All
Phase 3

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.
Study details
    Diabetic Macular Edema

NCT04108156

Hoffmann-La Roche

7 June 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Race
Ethnicity
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.