RGX-314-3101 (Macular Degeneration)

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.

Who Can Participate?

Eligibility

Adults ages 50-89 who:<ul>
<li>Are diagnosed with neovascular age-related macular degeneration</li>
<li>Have previously been treated with ranibizumab</li>
<li>Do not have a history of retinal detachment</li></ul>
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.

Age Range

50-89

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

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:<ul>
<li>Keep in touch with the study team for 1-2 years</li>
<li>Visit our clinic at the Duke Eye Center between 14 and 22 times</li></ul>
At various times during the clinic visits, you will have blood tests, answer some questionnaires, and have eye exams and vision tests.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

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

Lejla
Vajzovic

Protocol Number

PRO00110162

NCT ID

NCT05407636

Phase

III

Enrollment Status

Open to Enrollment