Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD
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
1 other identifier
observational
115
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2021
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2021
CompletedFirst Submitted
Initial submission to the registry
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
January 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
June 18, 2025
June 1, 2025
6.2 years
January 14, 2022
June 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
• To evaluate the persistence of effect of RGX-314 on best corrected visual acuity (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)
5 years inclusive of parent study
• To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy
5 years inclusive of parent study
• To assess the need of clinic visits for management of nAMD
5 years inclusive of parent study
Study Arms (1)
Roll over
No intervention All subjects that previously received RGX-314 in a parent study
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- \. None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (16)
Retinal Research Institute, LLC
Phoenix, Arizona, 85014, United States
California Retina Consultants
Bakersfield, California, 93309, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Northern California Retina Vitreous Associates Medical Group Inc
Mountain View, California, 94040, United States
Retina Consultants San Diego
Poway, California, 92064, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Southeast Retina Center PC
Augusta, Georgia, 30909, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Vitreoretinal Surgery PLLC
Edina, Minnesota, 55435, United States
Sierra eye Associates
Reno, Nevada, 89502, United States
Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico, 87109, United States
Retinovitreous Associates, LTD
Philadelphia, Pennsylvania, 19107, United States
Charles Retina Institute, P.C
Germantown, Tennessee, 38138, United States
Tennessee Retina, PC
Nashville, Tennessee, 37203, United States
Retina Consultants of Texas
The Woodlands, Texas, 77384, United States
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2022
First Posted
January 27, 2022
Study Start
December 20, 2021
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
June 18, 2025
Record last verified: 2025-06