Open for Enrollment Soon

This study will open for enrollment soon. Please contact the study team for more information and check back frequently.

AAVIATE - RGX-314-2102 (Age-Related Macular Degeneration) - Clinical Trial

What is the 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.

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 been diagnosed for fewer than 4 years
Have never received any type of gene therapy

For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.

Age Group

Adults

What is Involved?

If you choose to join the study, you will:

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.
Be in touch with the study team for about 56 weeks
Visit our clinic at the Duke Eye Center up to 19 times during the study

At various visits, you will have blood tests, you will answer some questionnaires, and have eye exams and vision tests.

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