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Clinical Trial Summary

This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study of DR without center involved-diabetic macular edema (CI-DME) in which they received SCS administration of RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for a total of 5 years post-RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following RGX-314 administration in the parent study.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05296447
Study type Observational
Source AbbVie
Contact
Status Enrolling by invitation
Phase
Start date April 4, 2022
Completion date May 2028