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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.

What is the Condition Being Studied?

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.

Age Group
Adults

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.

Study Details

Full Title
A Three-Part, Phase I/II Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Zifibancimig Following Intravitreal Administration of Multiple Ascending Doses and Continuous Delivery from the Port Delivery in Patients with Neovascular Age-Related Macular Degeneration (BURGUNDY) - BP41670
Principal Investigator
Ophthalmologist
Protocol Number
IRB: PRO00115640
NCT: NCT04567303
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon