Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy

AbbVie

Status: Invitation-only

Conditions: Diabetic Retinopathy, DR

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05296447

RGX-314-5201

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must provide written, signed informed consent for this study
• Must have been enrolled in a previous clinical study of RGX-314 for the treatment of DR without CI-DME and must have received an SCS injection of RGX-314 in that study
• Must be willing and able to comply with all study procedures

Exclusion criteria

• None

Trial design

100 participants in 1 patient group

Roll Over

Description:

No intervention - all subjects that previously received RGX-314 in a parent study

Treatment:

Other: No Intervention