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

Conditions

• Diabetic Retinopathy, DR

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Standard of Care — DRUG
  Standard of Care
• Aflibercept — DRUG
  Injection

Study Details

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.

Key Dates

First listed

Mar 25, 2022

Start date

Apr 4, 2022

Status verified

Aug 2026

Primary completion

Jun 30, 2031

Completion

Jun 30, 2031

Study Design

Enrollment

100 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Standard of Care
  Dose Level (DL) 1-3 participants who received ABBV-RGX-314 in a parent study will continue to receive standard of care for the study duration.
• Other: Supplemental Treatment
  DL4 participants from parent study will be eligible to receive supplement aflibercept through a prespecified timepoint based on protocol-specified criteria if they develop worsening CI-DME or high-risk proliferative diabetic retinopathy (PDR) in the study eye.

Primary Outcome Measure

Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs) [ Time Frame: 5 years inclusive of the parent study ]

Locations (20)

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