BURGUNDY - BP41670 (Neovascular Age-Related Macular Degeneration) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called zifibancimig (the study drug) is a safe and effective option for people with neovascular age-related macular degeneration (nAMD). We want to see how well it works in comparison to ranibizumab, which is an FDA-approved drug for the treatment of nAMD. Both the study drug and approved drug that are used in this study are given as eye implants.
Neovascular Age-Related Macular Degeneration (nAMD) AKA "Wet AMD"
Who Can Participate in the Study?
Adults ages 50+ who:
- Are diagnosed with nAMD (within 9 months of joining study)
- Have not received treatment with intravitreal corticosteroids or an eye implant
- Have not received a gene therapy for nAMD
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
What is Involved?
If you choose to join the study, you will get a random assignment (fair, equal chance) to 1 of 3 groups. Depending on your assignment, you may:
- Get an eye implant filled with a lower dose of the study drug (40 mg/mL); OR
- Get an eye implant filled with a higher dose of the study drug (80 mg/mL); OR
- Get an eye implant filled with ranibizumab
This study will last for up to 3 years and involve about 30 visits to our clinic. At various visits, you will have blood tests, eye exams, and vision tests.