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

AbbVie

Status: Invitation-only

Conditions: Gene Therapy; Wet AMD; AMD; wAMD; nAMD; Neovascular Age-Related Macular Degeneration (nAMD)

Treatments: Other: No intervention.

Study type: Observational

Funder types: Industry

Identifiers

NCT05210803

RGX-314-5102

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 nAMD in which they received suprachoroidal space (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 up to 5 years after 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: 115 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 RGX-314 in the treatment of nAMD and must have received an SCS injection of RGX-314 in that study.
3. Must be willing and able to comply with all study procedures.

Exclusion criteria

1. None

Trial design

115 participants in 1 patient group

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Description:

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

Treatment:

Other: No intervention.