Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD
- Conditions
- wAMDNeovascular Age-Related Macular Degeneration (nAMD)Wet AMDnAMDGene TherapyAMD
- Interventions
- Other: No intervention.
- Registration Number
- NCT05210803
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 115
- 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.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Roll over No intervention. No intervention All subjects that previously received RGX-314 in a parent study
- Primary Outcome Measures
Name Time Method To evaluate the long-term safety of RGX-314 5 years inclusive of parent study Incidences of ocular Adverse Events and Serious Adverse Events, and all Adverse Events of Special Interest
- Secondary Outcome Measures
Name Time Method • 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 • Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in CRT as measured by SD-OCT
• To evaluate the persistence of effect of RGX-314 on best corrected visual acuity (BCVA) 5 years inclusive of parent study • Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA
• To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy 5 years inclusive of parent study • Mean number of supplemental anti-VEGF injections based on chart review
• To assess the need of clinic visits for management of nAMD 5 years inclusive of parent study • Mean number of retina specialist visits attended for nAMD based on chart review
Trial Locations
- Locations (15)
California Retina Consultants
🇺🇸Santa Barbara, California, United States
Northern California Retina Vitreous Associates Medical Group Inc
🇺🇸Mountain View, California, United States
Southeast Retina Center PC
🇺🇸Augusta, Georgia, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Retinovitreous Associates, LTD
🇺🇸Philadelphia, Pennsylvania, United States
Retina Consultants of Texas
🇺🇸The Woodlands, Texas, United States
Sierra eye Associates
🇺🇸Reno, Nevada, United States
Retinal Research Institute, LLC
🇺🇸Phoenix, Arizona, United States
Tennessee Retina, PC
🇺🇸Nashville, Tennessee, United States
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Retina Consultants San Diego
🇺🇸Poway, California, United States
Vitreoretinal Surgery PLLC
🇺🇸Edina, Minnesota, United States
Vision Research Center Eye Associates of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Charles Retina Institute, P.C
🇺🇸Germantown, Tennessee, United States