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Enrolling By Invitation NCT05296447

Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy

Conditions: Diabetic Retinopathy, DR

Sex: All
Healthy volunteers: No
Phase: PHASE2
Enrollment: 100
Sponsor: AbbVie

Location: Retinal Research Institute, LLC Phoenix Arizona

Summary

This is a prospective study designed to evaluate the long-term safety and efficacy of ABBV-RGX-314. Eligible participants are those who were previously enrolled in a clinical study of DR with and without center involved-diabetic macular edema (CI-DME) in which they received suprachoroidal space (SCS) administration of ABBV-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-ABBV-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 ABBV-RGX-314 administration in the parent study.

Eligibility Criteria

Inclusion Criteria: * Must provide written, signed informed consent for this study * Must have been enrolled in a previous clinical study of ABBV-RGX-314 for the treatment of DR with or without CI-DME and must have received an SCS injection of ABBV-RGX-314 in that study * Must be willing and able to comply with all study procedures Exclusion Criteria: * None

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05296447). StuddyBuddy aggregates publicly available trial information.