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

Conditions

• Diabetic Retinopathy, DR

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• No Intervention — OTHER
  All subjects that previously received RGX-314 in a parent study

Study Details

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.

Key Dates

Start date

Apr 4, 2022

Status verified

Jun 2025

Primary completion

May 31, 2028

Completion

May 31, 2028

Study Design

Enrollment

100 participants (estimated)

Arms

• Arm: Roll Over
  No intervention - all subjects that previously received RGX-314 in a parent study

Primary Outcome Measure

To evaluate the long-term safety of RGX-314 [ Time Frame: 5 years inclusive of the parent study ]

Locations (19)

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