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

¿Cuál es el Propósito de este estudio?

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.

¿Cuál es la Condición que se está estudiando?

Neovascular Age-Related Macular Degeneration

¿Quién puede participar en el Estudio?

Adultos de 50 a 89 años que:

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.

Grupo etario

Adultos

¿Qué Implica?

Si decide participar en el estudio, podrá:

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.

Detalles del Estudio

Título Completo

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 (also known as M23-411)

Investigador Principal