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Enrolling by Invitation

NCT Number: NCT05210803

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

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration (nAMD) AMD Gene Therapy Wet AMD nAMD wAMD

Sex eligibility

All sexes

Study type

Observational

Primary location

Retinal Research Institute, LLC, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • None

Treatment and study plan

No intervention.

Other

All subjects that previously received RGX-314 in a parent study

Primary outcomes

  1. To evaluate the long-term safety of RGX-314

    Time frame: 5 years inclusive of parent study

    Incidences of ocular Adverse Events and Serious Adverse Events, and all Adverse Events of Special Interest

Secondary outcomes

  1. • To evaluate the persistence of effect of RGX-314 on best corrected visual acuity (BCVA)

    Time frame: 5 years inclusive of parent study

    • Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA

  2. • To evaluate the persistence of effect of RGX-314 on central retinal thickness (CRT), as measured by spectral domain-optical coherence tomography (SD-OCT)

    Time frame: 5 years inclusive of parent study

    • Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in CRT as measured by SD-OCT

  3. • To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy

    Time frame: 5 years inclusive of parent study

    • Mean number of supplemental anti-VEGF injections based on chart review

  4. • To assess the need of clinic visits for management of nAMD

    Time frame: 5 years inclusive of parent study

    • Mean number of retina specialist visits attended for nAMD based on chart review

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Jan 27, 2022
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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