Purpose of this Study
We are doing this study to find out if an experimental drug called RGX-314 (the study drug) is a safe and effective treatment for wet macular degeneration (WMD). RGX-314 is an experimental gene therapy drug that is designed to make people's bodies produce a protein that blocks the production of a bodily substance called vascular endothelial growth factor (VEGF). We want to know if this drug can continually block the production of VEGF, which might help prevent fluid build-up in the eye.
Who Can Participate?
Eligibility
Adults ages 50-89 who:
- Are diagnosed with wet macular degeneration
- Have received less than 12 injections
- Have had cataract surgery
- Have not previously had a retinal detachment
- Are not currently being treated for advanced Glaucoma
For more information about who can join this study, please contact the study team at DEC-RA@duke.edu.
- Are diagnosed with wet macular degeneration
- Have received less than 12 injections
- Have had cataract surgery
- Have not previously had a retinal detachment
- Are not currently being treated for advanced Glaucoma
For more information about who can join this study, please contact the study team at DEC-RA@duke.edu.
Age Range
55-89
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
This study is divided into two periods: the screening period and the study drug period.
During the screening period, you will:
- Have eye exams
- Have vision tests
- Get images taken of your eyes
If the study doctor thinks you are eligible to join the study, you will get an injection of a drug called ranibizumab and scheduled for a follow-up visit. Ranibizumab is an approved drug for the treatment of WMD. If we find that you responded to the ranibizumab injection during the follow-up visit, you will proceed to the study drug period.
During the study drug period, you will:
- Have eye exams
- Have vision tests
- Get images taken of your eyes;
- Be randomly assigned (fair, equal chance) to 1 of 3 groups
-- One group will get a high dose injection of the study drug
-- Another group will get a low dose injection of the study drug
-- The third group will continue to be treated with ranibizumab
If you are assigned to get the study drug, you will receive only one dose.
If you are assigned to get ranibizumab, you will have injections every month for one year. You will have the option to get the study drug after treatment with ranibizumab is done.
During the screening period, you will:
- Have eye exams
- Have vision tests
- Get images taken of your eyes
If the study doctor thinks you are eligible to join the study, you will get an injection of a drug called ranibizumab and scheduled for a follow-up visit. Ranibizumab is an approved drug for the treatment of WMD. If we find that you responded to the ranibizumab injection during the follow-up visit, you will proceed to the study drug period.
During the study drug period, you will:
- Have eye exams
- Have vision tests
- Get images taken of your eyes;
- Be randomly assigned (fair, equal chance) to 1 of 3 groups
-- One group will get a high dose injection of the study drug
-- Another group will get a low dose injection of the study drug
-- The third group will continue to be treated with ranibizumab
If you are assigned to get the study drug, you will receive only one dose.
If you are assigned to get ranibizumab, you will have injections every month for one year. You will have the option to get the study drug after treatment with ranibizumab is done.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Randomized, Partially Masked, Controlled, Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ATMOSPHERE) - RGX-314-2104
Principal Investigator
Lejla
Vajzovic
Protocol Number
PRO00108338
NCT ID
NCT04704921
Phase
II/III
Enrollment Status
OPEN TO ACCRUAL