ARTEMIS - ADVM-022-12 (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 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).
Neovascular Age-Related Macular Degeneration ("Wet" AMD)
Who Can Participate in the Study?
Adults ages 50+ who:
- Are diagnosed with wet AMD
- Have not received any prior gene therapy
- Have no allergy to aflibercept or corticosteroids
For more information, contact the study team at victoria.griffiths@duke.edu.
What is Involved?
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.
Participation in this study will last for approximately 5 years. For the first 2 years, you will come to the study clinic approximately every 4 weeks (every month), then every 12 weeks (every 3 months) thereafter.
Study Details
