Purpose of this Study
We are doing this study to find out if an experimental gene therapy drug called ABBV-RGX-314 (the study drug) has similar effects to approved drugs, such as Lucentis® or Eylea® injections. The study drug will be injected into one eye with a Suprachoroidal Space (SCS) Microinjector®, which is an investigational needle device developed by Clearside Biomedical, Inc.
Who Can Participate?
Eligibility
Adults ages 50-89 who:<ul>
<li> Are diagnosed with neovascular age-related macular degeneration</li>
<li> Have been diagnosed for fewer than 4 years</li>
<li> Have never received any type of gene therapy</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 neovascular age-related macular degeneration</li>
<li> Have been diagnosed for fewer than 4 years</li>
<li> Have never received any type of gene therapy</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:<ul>
<li>Get 2 injections that are 4 weeks apart of Lucentis® during a study screening period. If at the end of this screening period you are eligible to continue in the study, you will get a random assignment (like drawing numbers from a hat) to 1 of 2 groups: the study drug group or the Lucentis® control group.</li>
<li>Be in touch with the study team for about 56 weeks</li>
<li>Visit our clinic at the Duke Eye Center up to 19 times during the study</li></ul>
At various visits, you will have blood tests, you will answer some questionnaires, and have eye exams and vision tests.
<li>Get 2 injections that are 4 weeks apart of Lucentis® during a study screening period. If at the end of this screening period you are eligible to continue in the study, you will get a random assignment (like drawing numbers from a hat) to 1 of 2 groups: the study drug group or the Lucentis® control group.</li>
<li>Be in touch with the study team for about 56 weeks</li>
<li>Visit our clinic at the Duke Eye Center up to 19 times during the study</li></ul>
At various visits, you will have blood tests, you will answer some questionnaires, and have eye exams and vision tests.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 2, Randomized, Dose-escalation, Ranibizumab-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of RGX-314 Gene Therapy Delivered via One or Two Suprachoroidal Space (SCS) Injections in Participants with Neovascular Age-Related Macular Degeneration (nAMD) (AAVIATE) - RGX-314-2102
Principal Investigator
Lejla
Vajzovic
Protocol Number
PRO00113562
NCT ID
NCT04514653
Phase
II
Enrollment Status
Pending Open to Enrollment