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
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Neovascular Age-Related Macular Degeneration (nAMD)

Eligibility Criteria

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

Interventions

  • Standard of Care — DRUG
    Standard of Care
  • Ranibizumab — DRUG
    Injection

Study Details

This is a prospective study designed to evaluate the long-term safety and efficacy of ABBV-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 ABBV-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 ABBV-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 ABBV-RGX-314 administration in the parent study.

Key Dates

First listed
Jan 27, 2022
Start date
Dec 20, 2021
Status verified
Aug 2026
Primary completion
Jul 31, 2031
Completion
Jul 31, 2031

Study Design

Enrollment
116 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Standard of Care
    Dose Level (DL) 1-3 participants who received ABBV-RGX- 314 in the parent study will continue to receive standard of care for the study duration.
  • Other: Supplemental Treatment
    DL 4 participants from the parent study will be able to receive supplement ranibizumab based on protocol-specified criteria if they develop worsening nAMD activity.

Primary Outcome Measure

Incidences of ocular Adverse Events and any Serious Adverse Events [ 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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Retinal Research Institute, LLC· Phoenix, AZCalifornia Retina Consultants· Bakersfield, CARetina-Vitreous Associates Medical Group· Beverly Hills, CANorthern California Retina Vitreous Associates Medical Group Inc· Mountain View, CARetina Consultants San Diego· Poway, CACalifornia Retina Consultants· Santa Barbara, CA

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