RGX-314 Gene Therapy Pharmacodynamic Study for Neovascular Age-related Macular Degeneration (nAMD)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AbbVie
Study ID
NCT04832724
Phase
PHASE2
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration
  • Wet Age-related Macular Degeneration
  • Wet Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • RGX-314 — GENETIC
    RGX-314 is a recombinant adeno-associated virus gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein

Study Details

RGX-314 is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (nAMD) also referred to as Wet AMD. Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. The purpose of this phase 2, open label study is to evaluate whether different doses of RGX-314 from two different formulations (clinical versus eventual commercial formulation) perform the same in humans when delivered by subretinal administration

Key Dates

Start date
Feb 22, 2021
Status verified
Sep 2024
Primary completion
Oct 2, 2023
Completion
Mar 18, 2024

Study Design

Enrollment
60 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Commercial Formulation Dose 1
    Dose 1 of RGX-314
  • Experimental: Clinical Formulation Dose 1
    Dose 1 of RGX-314
  • Experimental: Commercial Formulation Dose 2
    Dose 2 of RGX-314
  • Experimental: Clinical Formulation Dose 2
    Dose 2 of RGX-314

Primary Outcome Measure

RGX-314 target protein concentration in aqueous humor [ Time Frame: At Week 24 ]

Locations (13)

FacilityCityStateZIPSite coordinators
Retinal Consultants of ArizonaPhoenixArizona85014-
Barnet Dulaney Perkins Eye CenterSun CityArizona85351-
Retina Consultants of San DiegoSan DiegoCalifornia92064-
California Retina ConsultantsSanta BarbaraCalifornia93103-
Retina Vitreous Associates of FloridaSt. PetersburgFlorida33711-
Wilmer Eye InstituteBaltimoreMaryland21287-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
Sierra Eye AssociatesRenoNevada89502-
Eye Associates of New MexicoAlbuquerqueNew Mexico87109-
Wills Eye HospitalPhiladelphiaPennsylvania19107-
Charles Retina InstituteGermantownTennessee38138-
Texas Retina AssociatesDallasTexas75231-
Retina Consultants of TexasThe WoodlandsTexas77384-

Find similar trials in Phoenix, AZ

By research site
Retinal Consultants of Arizona· Phoenix, AZBarnet Dulaney Perkins Eye Center· Sun City, AZRetina Consultants of San Diego· San Diego, CACalifornia Retina Consultants· Santa Barbara, CARetina Vitreous Associates of Florida· St. Petersburg, FLWilmer Eye Institute· Baltimore, MD

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