ALTITUDE - RGX-2202 (Diabetic Retinopathy) - Clinical Trial
What is the 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.
What is the Condition Being Studied?
Diabetic Retinopathy
Who Can Participate in the Study?
Adults ages 25-89 who:
- Are diagnosed with diabetic retinopathy
- Do not have an active eye infection
For more information, contact the study team at DEC-RA@duke.edu.
Age Group
Adults
What is Involved?
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.
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
Ophthalmologist
Protocol Number
IRB:
PRO00106637
NCT:
NCT04567550
Phase
Phase
II
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment