Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03917472
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Brolucizumab — DRUG
    Intravitreal injection
  • Aflibercept — DRUG
    Intravitreal injection

Study Details

The purpose of this study was to evaluate the efficacy and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to diabetic macular edema (DME).

Key Dates

Start date
Jul 17, 2019
Status verified
Aug 2022
Primary completion
Mar 24, 2021
Completion
Mar 24, 2021

Study Design

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

Arms

  • Experimental: Brolucizumab 6mg q4w
    Brolucizumab 6 mg/0.05 mL every 4 weeks.
  • Active Comparator: Aflibercept 2mg q4w
    Aflibercept 2mg/0.05 mL every 4 weeks

Primary Outcome Measure

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

Locations (74)

FacilityCityStateZIPSite coordinators
Novartis Investigative SitePhoenixArizona85016-
Novartis Investigative SitePhoenixArizona85053-
Novartis Investigative SiteTucsonArizona85704-5614-
Novartis Investigative SiteBeverly HillsCalifornia90211-
Novartis Investigative SiteCampbellCalifornia95008-
Novartis Investigative SiteFresnoCalifornia93720-
Novartis Investigative SiteHuntington BeachCalifornia92647-
Novartis Investigative SiteLoma LindaCalifornia92354-
Novartis Investigative SiteMountain ViewCalifornia94040-
Novartis Investigative SiteOaklandCalifornia94609-
Novartis Investigative SitePasadenaCalifornia91107-
Novartis Investigative SitePowayCalifornia92064-
Novartis Investigative SiteRancho CordovaCalifornia95670-
Novartis Investigative SiteRedlandsCalifornia92374-
Novartis Investigative SiteRiversideCalifornia92505-
Novartis Investigative SiteSacramentoCalifornia95817-
Novartis Investigative SiteSacramentoCalifornia95841-
Novartis Investigative SiteSan FranciscoCalifornia94107-
Novartis Investigative SiteSanta AnaCalifornia92705-
Novartis Investigative SiteSanta BarbaraCalifornia93103-
Novartis Investigative SiteTorranceCalifornia90509-2910-
Novartis Investigative SiteVenturaCalifornia93003-
Novartis Investigative SiteAltamonte SpringsFlorida32701-
Novartis Investigative SiteDeerfield BeachFlorida33064-
Novartis Investigative SiteFort LauderdaleFlorida33309-
Novartis Investigative SiteFort MyersFlorida33912-7125-
Novartis Investigative SiteOrlandoFlorida32804-
Novartis Investigative SitePinellas ParkFlorida33782-
Novartis Investigative SiteSt. PetersburgFlorida33711-
Novartis Investigative SiteTampaFlorida33609-
Novartis Investigative SiteAtlantaGeorgia30342-
Novartis Investigative SiteMariettaGeorgia30060-
Novartis Investigative Site‘AieaHawaii96701-
Novartis Investigative SiteBloomingtonIllinois61704-
Novartis Investigative SiteOak ForestIllinois60452-
Novartis Investigative SiteSpringfieldIllinois62704-
Novartis Investigative SiteIndianapolisIndiana46280-
Novartis Investigative SiteNew AlbanyIndiana47150-
Novartis Investigative SiteWest Des MoinesIowa50266-
Novartis Investigative SiteLeawoodKansas66211-
Novartis Investigative SiteLenexaKansas66215-
Novartis Investigative SiteHagerstownMaryland21740-
Novartis Investigative SiteBostonMassachusetts02114-
Novartis Investigative SiteRoyal OakMichigan48073-
Novartis Investigative SiteMinneapolisMinnesota55435-
Novartis Investigative SiteKansas CityMissouri64133-
Novartis Investigative SiteRenoNevada89502-
Novartis Investigative SiteBloomfieldNew Jersey07003-
Novartis Investigative SiteTeaneckNew Jersey07666-
Novartis Investigative SiteRochesterNew York14620-
Novartis Investigative SiteHickoryNorth Carolina28602-
Novartis Investigative SiteSouthern PinesNorth Carolina28387-
Novartis Investigative SiteClevelandOhio44122-
Novartis Investigative SiteColumbusOhio43210-
Novartis Investigative SiteDublinOhio43016-
Novartis Investigative SiteEugeneOregon97401-
Novartis Investigative SiteKingstonPennsylvania95403-
Novartis Investigative SiteChattanoogaTennessee37421-
Novartis Investigative SiteGermantownTennessee38138-
Novartis Investigative SiteAbileneTexas79606-
Novartis Investigative SiteAustinTexas78705-
Novartis Investigative SiteAustinTexas78731-
Novartis Investigative SiteAustinTexas78750-
Novartis Investigative SiteBellaireTexas77401-
Novartis Investigative SiteDallasTexas75231-
Novartis Investigative SiteFort WorthTexas76104-
Novartis Investigative SiteHarlingenTexas78550-
Novartis Investigative SiteHoustonTexas77025-
Novartis Investigative SiteHoustonTexas77030-
Novartis Investigative SiteSan AntonioTexas78240-
Novartis Investigative SiteSouthlakeTexas76092-
Novartis Investigative SiteNorfolkVirginia23502-
Novartis Investigative SiteMorgantownWest Virginia26506-
Novartis Investigative SiteMadisonWisconsin53705-3611-

Find similar trials in Phoenix, AZ

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Novartis Investigative Site· Phoenix, AZNovartis Investigative Site· Tucson, AZNovartis Investigative Site· Beverly Hills, CANovartis Investigative Site· Campbell, CANovartis Investigative Site· Fresno, CANovartis Investigative Site· Huntington Beach, CA

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