Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AbbVie
Study ID
NCT03999801
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Neovascular Age-related Macular Degeneration
  • Wet Macular Degeneration

Eligibility Criteria

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

Interventions

  • RGX-314 — GENETIC
    AAV8 vector containing a transgene for anti-VEGF Fab

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 in which they received a single subretinal administration of RGX-314 in their study eye. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early termination visit in the previous (parent) clinical study. Participants will be followed for up to 5 years post-RGX-314 administration (inclusive of the parent study). After enrollment and a 6-month follow-up visit, participants will attend at least annual study visits through the end of the 5-year post-RGX-314 administration follow-up period. Additionally, an interventional fellow eye treatment substudy will evaluate the safety, efficacy, and immunogenicity of subretinal RGX-314 administration in the fellow eye of participants having bilateral disease who previously received a subretinal injection of RGX-314 in their study eye. Participants who qualify for the substudy will receive subretinal administration of RGX-314 in their fellow eye and complete 13 study visits in a 54-week period. Following completion of the substudy participants will continue in the observational portion of the study for up to 5 years post RGX-314 administration in their fellow eye.

Key Dates

Start date
May 31, 2019
Status verified
Jun 2024
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
865 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • No Intervention: Main Observational Study
    All subjects that previously received RGX-314 in a subretinal administration parent study are enrolled into this arm.
  • Experimental: RGX-314 Fellow Eye Treatment Substudy
    RGX-314 Fellow Eye Treatment

Primary Outcome Measure

Incidence of ocular adverse events and any serious adverse events in the study eye [ Time Frame: 5 years inclusive of parent study ]

Locations (9)

FacilityCityStateZIPSite coordinators
Retinal Research Institute, LCCPhoenixArizona85053-
California Retina Consultants CRCSanta BarbaraCalifornia93103-
Johns Hopkins UniversityBaltimoreMaryland21287-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
Sierra Eye AssociatesRenoNevada89502-
MidAtlantic RetinaPhiladelphiaPennsylvania19107-
University of Pennsylvania Department of OphthalmologyPhiladelphiaPennsylvania19104-
Charles Retina InstituteGermantownTennessee38138-
Retina Consultants of Texas Research CenterThe WoodlandsTexas77384-

Find similar trials in Phoenix, AZ

By research site
Retinal Research Institute, LCC· Phoenix, AZCalifornia Retina Consultants CRC· Santa Barbara, CAJohns Hopkins University· Baltimore, MDOphthalmic Consultants of Boston· Boston, MASierra Eye Associates· Reno, NVMidAtlantic Retina· Philadelphia, PA

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