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

Study Overview
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Brief Summary
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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.

Official Title
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A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Participants With Neovascular Age-Related Macular Degeneration

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

Intervention / Treatment
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* Other: No intervention.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must provide written, signed informed consent for this study. 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. Must be willing and able to comply with all study procedures. Exclusion Criteria: 1. None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Roll over<br>No intervention All subjects that previously received RGX-314 in a parent study | Other: No intervention.<br>* All subjects that previously received RGX-314 in a parent study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the long-term safety of RGX-314 | Incidences of ocular Adverse Events and Serious Adverse Events, and all Adverse Events of Special Interest | 5 years inclusive of parent study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • To evaluate the persistence of effect of RGX-314 on best corrected visual acuity (BCVA) | • Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA | 5 years inclusive of parent study | 
| • To evaluate the persistence of effect of RGX-314 on central retinal thickness (CRT), as measured by spectral domain-optical coherence tomography (SD-OCT) | • Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in CRT as measured by SD-OCT | 5 years inclusive of parent study | 
| • To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy | • Mean number of supplemental anti-VEGF injections based on chart review | 5 years inclusive of parent study | 
| • To assess the need of clinic visits for management of nAMD | • Mean number of retina specialist visits attended for nAMD based on chart review | 5 years inclusive of parent study |