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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AbbVie
Study ID
NCT05210803
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • No intervention. — OTHER
    All subjects that previously received RGX-314 in a parent study

Study Details

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.

Key Dates

Start date
Dec 20, 2021
Status verified
Jun 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
115 participants (estimated)

Arms

  • Arm: Roll over
    No intervention All subjects that previously received RGX-314 in a parent study

Primary Outcome Measure

To evaluate the long-term safety of RGX-314 [ Time Frame: 5 years inclusive of parent study ]

Locations (16)

FacilityCityStateZIPSite coordinators
Retinal Research Institute, LLCPhoenixArizona85014-
California Retina ConsultantsBakersfieldCalifornia93309-
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
Northern California Retina Vitreous Associates Medical Group IncMountain ViewCalifornia94040-
Retina Consultants San DiegoPowayCalifornia92064-
California Retina ConsultantsSanta BarbaraCalifornia93103-
Southeast Retina Center PCAugustaGeorgia30909-
Johns Hopkins UniversityBaltimoreMaryland21205-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
Vitreoretinal Surgery PLLCEdinaMinnesota55435-
Sierra eye AssociatesRenoNevada89502-
Vision Research Center Eye Associates of New MexicoAlbuquerqueNew Mexico87109-
Retinovitreous Associates, LTDPhiladelphiaPennsylvania19107-
Charles Retina Institute, P.CGermantownTennessee38138-
Tennessee Retina, PCNashvilleTennessee37203-
Retina Consultants of TexasThe WoodlandsTexas77384-

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