Study of Safety and Efficacy of Brolucizumab 6 mg Dosed Every 4 Weeks Compared to Aflibercept 2 mg Dosed Every 4 Weeks in Patients With Retinal Fluid Despite Frequent Anti-VEGF Injections

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03710564
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Brolucizumab — BIOLOGICAL
    6 mg/0.05mL solution for intravitreal injection
  • Aflibercept — BIOLOGICAL
    2 mg/0.05mL solution for intravitreal injection

Study Details

This clinical study was designed to compare the safety and efficacy of brolucizumab 6 mg dosed every 4 weeks to aflibercept 2 mg dosed every 4 weeks in those neovascular age-related macular degeneration (nAMD) patients with retinal fluid despite frequent anti-Vascular Endothelial Growth Factor (VEGF) injections.

Key Dates

Start date
Oct 30, 2018
Status verified
Jan 2023
Primary completion
Dec 21, 2020
Completion
Jul 1, 2021

Study Design

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

Arms

  • Experimental: Brolucizumab
    Brolucizumab 6 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.
  • Active Comparator: Aflibercept
    Aflibercept 2 mg dosed every 4 weeks was administered via intravitreal injection for 100 weeks.

Primary Outcome Measure

Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Week 52 [ Time Frame: Baseline, week 52 ]

Locations (60)

FacilityCityStateZIPSite coordinators
Novartis Investigative SitePhoenixArizona85016-
Novartis Investigative SitePhoenixArizona85020-
Novartis Investigative SitePhoenixArizona85053-
Novartis Investigative SiteBeverly HillsCalifornia90211-
Novartis Investigative SiteHuntington BeachCalifornia92647-
Novartis Investigative SiteMountain ViewCalifornia94040-
Novartis Investigative SiteOaklandCalifornia94609-
Novartis Investigative SiteOxnardCalifornia93036-
Novartis Investigative SitePalo AltoCalifornia94303-
Novartis Investigative SiteRedlandsCalifornia92374-
Novartis Investigative SiteSacramentoCalifornia95841-
Novartis Investigative SiteSan FranciscoCalifornia94107-
Novartis Investigative SiteSanta BarbaraCalifornia93103-
Novartis Investigative SiteColorado SpringsColorado80909-
Novartis Investigative SiteGoldenColorado80401-
Novartis Investigative SiteDeerfield BeachFlorida33064-
Novartis Investigative SiteFort LauderdaleFlorida33308-
Novartis Investigative SiteFort MyersFlorida33912-7125-
Novartis Investigative SiteMiamiFlorida33136-
Novartis Investigative SiteMt. DoraFlorida32757-
Novartis Investigative SitePensacolaFlorida32503-
Novartis Investigative SiteSt. PetersburgFlorida33711-
Novartis Investigative SiteStuartFlorida34994-
Novartis Investigative SiteMariettaGeorgia30060-
Novartis Investigative Site‘AieaHawaii96701-
Novartis Investigative SiteWheatonIllinois60187-
Novartis Investigative SiteWest Des MoinesIowa50266-
Novartis Investigative SiteLenexaKansas66215-
Novartis Investigative SiteNew OrleansLouisiana70115-8139-
Novartis Investigative SiteWest MonroeLouisiana71291-
Novartis Investigative SiteWaldorfMaryland20602-
Novartis Investigative SiteBostonMassachusetts02111-
Novartis Investigative SiteBostonMassachusetts02114-
Novartis Investigative SiteSpringfieldMassachusetts01107-
Novartis Investigative SiteRoyal OakMichigan48073-
Novartis Investigative SiteSt LouisMissouri63110-
Novartis Investigative SiteLas VegasNevada89144-
Novartis Investigative SiteRenoNevada89502-
Novartis Investigative SiteBloomfieldNew Jersey07003-
Novartis Investigative SiteToms RiverNew Jersey08755-
Novartis Investigative SiteSyracuseNew York13224-
Novartis Investigative SiteCharlotteNorth Carolina28210-
Novartis Investigative SiteClevelandOhio44122-
Novartis Investigative SiteFairfieldOhio45014-
Novartis Investigative SiteEugeneOregon97401-
Novartis Investigative SiteKingstonPennsylvania95403-
Novartis Investigative SitePhiladelphiaPennsylvania19107-
Novartis Investigative SiteGermantownTennessee38138-
Novartis Investigative SiteAbileneTexas79606-
Novartis Investigative SiteAustinTexas78705-
Novartis Investigative SiteAustinTexas78731-
Novartis Investigative SiteAustinTexas78793-
Novartis Investigative SiteFort WorthTexas76102-
Novartis Investigative SiteFort WorthTexas76104-
Novartis Investigative SiteHarlingenTexas78550-
Novartis Investigative SiteHoustonTexas77030-
Novartis Investigative SiteSan AntonioTexas78240-
Novartis Investigative SiteTylerTexas75701-
Novartis Investigative SiteFairfaxVirginia22031-
Novartis Investigative SiteSpokaneWashington99204-

Find similar trials in Phoenix, AZ

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Novartis Investigative Site· Phoenix, AZNovartis Investigative Site· Beverly Hills, CANovartis Investigative Site· Huntington Beach, CANovartis Investigative Site· Mountain View, CANovartis Investigative Site· Oakland, CANovartis Investigative Site· Oxnard, CA

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