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.
Who Can Participate?
Eligibility
Adults ages 50+ who:<ul>
<li>Are diagnosed with nAMD (within 9 months of joining study)</li>
<li>Have not received treatment with intravitreal corticosteroids or an eye implant</li>
<li>Have not received a gene therapy for nAMD</li></ul>
For more information about who can be in this study, please contact the study team at <a href= "mailto: DEC-RA@duke.edu"> DEC-RA@duke.edu.</a>
<li>Are diagnosed with nAMD (within 9 months of joining study)</li>
<li>Have not received treatment with intravitreal corticosteroids or an eye implant</li>
<li>Have not received a gene therapy for nAMD</li></ul>
For more information about who can be in this study, please contact the study team at <a href= "mailto: DEC-RA@duke.edu"> DEC-RA@duke.edu.</a>
Age Range
55-89
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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:<ul>
<li>Get an eye implant filled with a lower dose of the study drug (40 mg/mL); OR</li>
<li>Get an eye implant filled with a higher dose of the study drug (80 mg/mL); OR</li>
<li>Get an eye implant filled with ranibizumab</li></ul>
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.
<li>Get an eye implant filled with a lower dose of the study drug (40 mg/mL); OR</li>
<li>Get an eye implant filled with a higher dose of the study drug (80 mg/mL); OR</li>
<li>Get an eye implant filled with ranibizumab</li></ul>
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Three-Part, Phase I 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
Lejla
Vajzovic
Protocol Number
PRO00115640
NCT ID
NCT04567303
Phase
I
Enrollment Status
Pending Open to Enrollment