Purpose of this Study
We are doing this study to find out if an experimental drug called ixoberogene soroparvovec (the study drug) is a safe and effective option for people with neovascular age-related macular degeneration (wet AMD). We want to see how well it works compared to the currently approved standard treatment, Eylea® (aflibercept).
Who Can Participate?
Eligibility
Adults ages 50+ who:
- Are diagnosed with wet AMD
- Have not received any prior gene therapy
- Have no allergy to aflibercept or corticosteroids
Age Range
50-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 study groups:
- Arm 1: If you are in this group, you will get an injection of the study drug followed by "sham" injections every 8 weeks afterwards. The sham injections mimic a real intravitreal injection, but they do not penetrate the eye.
- Arm 2: If you are in this group, you will get a sham injection followed by aflibercept injections every 8 weeks afterwards.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Multi-Center, Randomized, Double-Masked, Active-Comparator-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Ixoberogene soroparvovec (Ixovec) in Participants with Neovascular Age-Related Macular Degeneration (ARTEMIS) - ADVM-022-12
Principal Investigator
Lejla
Vajzovic
Protocol Number
PRO00117654
Phase
III
Enrollment Status
Pending Open to Enrollment