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

AbbVie

Status and phase: Invitation-only; Phase 2

Conditions: Neovascular Age-Related Macular Degeneration (nAMD)

Treatments: Drug: Standard of Care; Drug: Ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05210803

RGX-314-5102 (M23-421)

M23-421 (Other Identifier)

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 nAMD 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 up to 5 years after 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: 116 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Must provide written, signed informed consent for this study.
2. Must have been enrolled in a previous clinical study of ABBV-RGX-314 in the treatment of nAMD and must have received an SCS injection of ABBV-RGX-314 in that study.
3. Must be willing and able to comply with all study procedures.

Exclusion criteria

1. None

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Standard of Care

Other group

Description:

Dose Level (DL) 1-3 participants who received ABBV-RGX- 314 in the parent study will continue to receive standard of care for the study duration.

Treatment:

Drug: Standard of Care

Supplemental Treatment

Other group

Description:

DL 4 participants from the parent study will be able to receive supplement ranibizumab based on protocol-specified criteria if they develop worsening nAMD activity.

Treatment:

Drug: Ranibizumab

Drug: Standard of Care