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

June 16, 2025 updated by: AbbVie

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Research Institute, LLC
    • California
      • Bakersfield, California, United States, 93309
        • California Retina Consultants
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates Medical Group Inc
      • Poway, California, United States, 92064
        • Retina Consultants San Diego
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center PC
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Vitreoretinal Surgery PLLC
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Vision Research Center Eye Associates of New Mexico
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Retinovitreous Associates, LTD
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Charles Retina Institute, P.C
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina, PC
    • Texas
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The sample sizes were determined by the parent studies and all participants who received an SCS administration of RGX-314 will be invited to participate in the long-term follow-up study. All Enrolled Population: Includes all participants who are enrolled in the long-term follow-up study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Roll over
No intervention All subjects that previously received RGX-314 in a parent study
Other: No intervention.
All subjects that previously received RGX-314 in a parent study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: 5 years inclusive of parent study
• 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)
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
5 years inclusive of parent study
• 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
5 years inclusive of parent study
• 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
5 years inclusive of parent study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Collaborators

AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2021

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 16, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGX-314-5102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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