ADVM-022 Intravitreal Gene Therapy for DME

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Adverum Biotechnologies, Inc.
Study ID
NCT04418427
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • 6E11 vg/eye of ADVM-022 — BIOLOGICAL
    ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept
  • 2E11 vg/eye of ADVM-022 — BIOLOGICAL
    ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept
  • Aflibercept — BIOLOGICAL
    Commercially available Active Comparator

Study Details

A Phase 2, Multi-Center, Randomized, Double-Masked\*, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects with Diabetic Macular Edema \[INFINITY\]

Key Dates

Start date
May 28, 2020
Status verified
Jun 2025
Primary completion
Nov 22, 2022
Completion
Jun 14, 2023

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT
  • Experimental: 2
    2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT
  • Active Comparator: 3
    Aflibercept 2mg IVT

Primary Outcome Measure

Time to Worsening of DME Disease Activity in the Study Eye. [ Time Frame: Day 1 through 96 weeks ]

Locations (13)

FacilityCityStateZIPSite coordinators
Adverum Clinical SitePhoenixArizona85014-
Adverum Clinical SiteBakersfieldCalifornia93309-
Adverum Clinical SiteBeverly HillsCalifornia90211-
Adverum Clinical SiteGoldenColorado80401-
Adverum Clinical SiteDeerfield BeachFlorida33064-
Adverum Clinical SiteRenoNevada89502-
Adverum Clinical SitePhiladelphiaPennsylvania19107-
Adverum Clinical SiteWest ColumbiaSouth Carolina29169-
Adverum Clinical SiteNashvilleTennessee37203-
Adverum Clinical SiteAbileneTexas79606-
Adverum Clinical SiteAustinTexas78705-
Adverum Clinical SiteHoustonTexas77030-
Adverum Clinical SiteThe WoodlandsTexas77384-

Find similar trials in Phoenix, AZ

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Adverum Clinical Site· Phoenix, AZAdverum Clinical Site· Bakersfield, CAAdverum Clinical Site· Beverly Hills, CAAdverum Clinical Site· Golden, COAdverum Clinical Site· Deerfield Beach, FLAdverum Clinical Site· Reno, NV

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