Clinical trial NCT05210803: Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD
Official 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Neovascular Age-Related Macular Degeneration (nAMD)
Gene Therapy
AMD
Wet AMD
wAMD
nAMD
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-01-27
Enrollment: 115
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the long-term safety of RGX-314
timeFrame: 5 years inclusive of parent study
Secondary outcomes:
measure: • To evaluate the persistence of effect of RGX-314 on best corrected visual acuity (BCVA)
timeFrame: 5 years inclusive of parent study
measure: • To evaluate the persistence of effect of RGX-314 on central retinal thickness (CRT), as measured by spectral domain-optical coherence tomography (SD-OCT)
timeFrame: 5 years inclusive of parent study
measure: • To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy
timeFrame: 5 years inclusive of parent study
measure: • To assess the need of clinic visits for management of nAMD
timeFrame: 5 years inclusive of parent study
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates Medical Group Inc
state: California
city: Poway
country: United States
facility: Retina Consultants San Diego
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Augusta
country: United States
facility: Southeast Retina Center PC
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Edina
country: United States
facility: Vitreoretinal Surgery PLLC
state: Minnesota
city: Reno
country: United States
facility: Sierra eye Associates
state: Nevada
city: Albuquerque
country: United States
facility: Vision Research Center Eye Associates of New Mexico
state: New Mexico
city: Philadelphia
country: United States
facility: Retinovitreous Associates, LTD
state: Pennsylvania
city: Germantown
country: United States
facility: Charles Retina Institute, P.C
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Retina, PC
state: Tennessee
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
Study officials:
References: