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

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard of Care: Standard of Care

Ranibizumab: Injection

Study summary

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.

Eligibility

Primary outcome measure(s)

• Incidences of ocular Adverse Events and any Serious Adverse Events — 5 years inclusive of parent study
  To evaluate the long-term safety of ABBV-RGX-314

Trial sites (16)

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