Study of 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
NCT03481634
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 in treatment of patients with visual impairment due to diabetic macular edema (DME).

Key Dates

Start date
Jul 23, 2018
Status verified
Jan 2023
Primary completion
Nov 11, 2020
Completion
Oct 18, 2021

Study Design

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

Arms

  • Experimental: Brolucizumab 3 mg
    Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule. To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP).
  • Experimental: Brolucizumab 6 mg
    Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule. To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP).
  • Active Comparator: Aflibercept 2 mg
    Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks. To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP).

Primary Outcome Measure

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

Locations (39)

FacilityCityStateZIPSite coordinators
Novartis Investigative SitePhoenixArizona85053-
Novartis Investigative SiteBeverly HillsCalifornia90211-
Novartis Investigative SiteLa JollaCalifornia92093-
Novartis Investigative SiteMountain ViewCalifornia94040-
Novartis Investigative SiteSanta BarbaraCalifornia93103-
Novartis Investigative SiteColorado SpringsColorado80909-
Novartis Investigative SiteDanburyConnecticut06810-
Novartis Investigative SiteMiamiFlorida33136-
Novartis Investigative SitePensacolaFlorida32503-
Novartis Investigative SiteStuartFlorida34994-
Novartis Investigative Site‘AieaHawaii96701-
Novartis Investigative SiteUrbanaIllinois61801-
Novartis Investigative SiteWheatonIllinois60187-
Novartis Investigative SiteIndianapolisIndiana46280-
Novartis Investigative SiteNew AlbanyIndiana47150-
Novartis Investigative SiteLeawoodKansas66211-
Novartis Investigative SiteLenexaKansas66215-
Novartis Investigative SitePaducahKentucky42001-
Novartis Investigative SiteSpringfieldMassachusetts01107-
Novartis Investigative SiteStonehamMassachusetts02180-
Novartis Investigative SiteRenoNevada89502-
Novartis Investigative SiteCincinnatiOhio45242-
Novartis Investigative SiteClevelandOhio44122-
Novartis Investigative SiteClevelandOhio44195-
Novartis Investigative SiteKingstonPennsylvania95403-
Novartis Investigative SitePhiladelphiaPennsylvania19107-
Novartis Investigative SiteMemphisTennessee38119-
Novartis Investigative SiteNashvilleTennessee37232-
Novartis Investigative SiteAustinTexas78705-
Novartis Investigative SiteAustinTexas78731-
Novartis Investigative SiteAustinTexas78750-
Novartis Investigative SiteBellaireTexas77401-
Novartis Investigative SiteHarlingenTexas78550-
Novartis Investigative SiteHoustonTexas77030-
Novartis Investigative SiteSan AntonioTexas78240-
Novartis Investigative SiteTylerTexas75701-
Novartis Investigative SiteSilverdaleWashington98383-
Novartis Investigative SiteSpokaneWashington99204-
Novartis Investigative SiteMadisonWisconsin53705-3611-

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By specialty
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By research site
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