Purpose of this Study
We are doing this study to find out if an investigational gene therapy drug called ABBV-RGX-314 (the study drug) is a safe and effective option for people with diabetic retinopathy. The study drug is delivered directly into the suprachoroidal space of the eye using a technology called Microinjector®, which is an experimental needle device.
Who Can Participate?
Eligibility
Adults ages 25-89 who:
- Are diagnosed with diabetic retinopathy
- Do not have an active eye infection
Age Range
25-89
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you are eligible to join the study and choose to do so, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- Group 1: If you are in this group, you will get the study drug. Approximately 2 weeks before the study drug injection, you will receive Durezol® (or equivalent steroid) eye drops to use at home for the 3 days before your injection. You will continue to use these eye drops for 12 weeks after the study drug injection. You will have 10 follow-up visits over the course of 1 year after you get the study drug.
- Group 2: If you are in this group, you will get Eylea®, which is one of the standard-of-care treatments, every 8 weeks for approximately 1 year. After this year is up, you will have the opportunity to get the study drug if the study doctor believes you are eligible and might benefit from it.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 2, Randomized, Controlled, Dose-escalation Study to Evaluate the Efficacy, Safety, and Tolerability of RGX-314 Gene Therapy Delivered via a Single Suprachoroidal Space (SCS) Injection in Participants with Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME) - ALTITUDE
Principal Investigator
Lejla
Vajzovic
Protocol Number
PRO00106637
NCT ID
NCT04567550
Phase
II
Enrollment Status
Open to Enrollment