Purpose of this Study
We are doing this study to find out is an experimental drug called RGX-314 can help improve or preserve vision. We will compare how this drug works to Eylea®, which is an approved therapy for age-related macular degeneration.
Who Can Participate?
Eligibility
Adults ages 50-89 who:
- Are diagnosed with neovascular age-related macular degeneration
- Have previously been treated with ranibizumab
- Do not have a history of retinal detachment
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
- Are diagnosed with neovascular age-related macular degeneration
- Have previously been treated with ranibizumab
- Do not have a history of retinal detachment
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
Age Range
50-89
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 receive either an injection of Eylea®, or the study drug at a low dose, or the study drug at a high dose (it will be decided by chance, like drawing numbers from a hat).
Depending on the drug you receive, you will:
- Keep in touch with the study team for 1-2 years
- Visit our clinic at the Duke Eye Center between 14 and 22 times
At various times during the clinic visits, you will have blood tests, answer some questionnaires, and have eye exams and vision tests.
Depending on the drug you receive, you will:
- Keep in touch with the study team for 1-2 years
- Visit our clinic at the Duke Eye Center between 14 and 22 times
At various times during the clinic visits, you will have blood tests, 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 Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ASCENT)
Principal Investigator
Lejla
Vajzovic
Protocol Number
PRO00110162
NCT ID
NCT05407636
Phase
III
Enrollment Status
OPEN TO ACCRUAL