RGX-314-3101 (Macular Degeneration) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Neovascular Age-Related Macular Degeneration

Who Can Participate in the Study?

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.

Age Group

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.

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
Protocol Number
IRB: PRO00110162
NCT: NCT05407636
Phase III
Enrollment Status
Open for Enrollment