The ASCENT Study: RGX-314-3101 (Macular Degeneration) - Clinical Trial

¿Cuál es el Propósito de este estudio?

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.

¿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 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.

Grupo etario
Adultos

¿Qué Implica?

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.

Detalles del Estudio

Título Completo
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)
Investigador Principal
Lejla Vajzovic, MD
Especialista en oftalmología
Número de Protocolo
IRB: PRO00110162
NCT: NCT05407636
Fase
Phase III
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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