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

AbbVie

Status and phase: Invitation-only; Phase 2

Conditions: Diabetic Retinopathy, DR

Treatments: Drug: Aflibercept; Drug: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT05296447

M23-420 (Other Identifier)

RGX-314-5201 (M23-420)

Details and patient eligibility

About

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.

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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Standard of Care

Other group

Description:

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.

Treatment:

Drug: Standard of Care

Supplemental Treatment

Other group

Description:

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.

Treatment:

Drug: Standard of Care

Drug: Aflibercept