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

A 12-Month, 2-Arm, Randomized, Double-Masked, Multicenter Phase III Study Assessing the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (KINGFISHER)

ClinicalTrials.gov Identifier: NCT03917472

Novartis Reference Number: CRTH258B2305

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to evaluate the efficacy and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to DME.

Condition 
Diabetic Macular Edema
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
521 participants
Start date 
Jul 17, 2019
Completion date 
Aug 13, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Brolucizumab
Intravitreal injection
Drug
Aflibercept
Intravitreal injection

Eligibility Criteria

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study.
Patients with type 1 or type 2 diabetes mellitus (DM) and Hemoglobin A1c (HbA1c) ≤ 12% at screening.

Study eye: Visual impairment due to DME with:

Best-corrected visual acuity (BCVA) score between 73 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters
DME involving the center of the macula, with Central Subfield Thickness (CSFT) ≥ 320 µm on Spectral Domain Optical Coherence Tomography (SD-OCT)

Exclusion Criteria:

High-risk proliferative diabetic retinopathy (PDR) in the study eye
Concomitant conditions or ocular disorders in the study eye which confound interpretation of study results, compromise visual acuity or require medical or surgical intervention
Any active intraocular or periocular infection or active intraocular inflammation in the either eye
Uncontrolled glaucoma in the study eye
Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA <20/200
Use of anti-VEGF therapies, intraocular surgery or laser photocoagulation (macular or panretinal) in the study eye during the 3-month period prior to baseline
Use of intraocular or periocular corticosteroids in the study eye during the 6-month period prior to baseline, and use of fluocinolone acetonide intravitreal (IVT) implant (Iluvien) at any time prior to baseline
Prior investigational drugs in either eye, vitreoretinal surgery in the study eye at any time prior to baseline

Study Locations

United States
Novartis Investigative Site
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Phoenix, 85016
Arizona
United States
Novartis Investigative Site
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Phoenix, 85020
Arizona
United States
Novartis Investigative Site
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Phoenix, 85021
Arizona
United States
Novartis Investigative Site
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Phoenix, 85053
Arizona
United States
Novartis Investigative Site
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Tucson, 85704-5614
Arizona
United States
Novartis Investigative Site
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Beverly Hills, 90211
California
United States
Novartis Investigative Site
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Campbell, 95008
California
United States
Novartis Investigative Site
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Fresno, 93720
California
United States
Novartis Investigative Site
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Huntington Beach, 92647
California
United States
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Loma Linda, 92354
California
United States
Novartis Investigative Site
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Mountain View, 94040
California
United States
Novartis Investigative Site
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Oakland, 94609
California
United States
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Pasadena, 91107
California
United States
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Poway, 92064
California
United States
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Rancho Cordova, 95670
California
United States
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Redlands, 92374
California
United States
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Riverside, 92501
California
United States
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Sacramento, 95817
California
United States
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Sacramento, 95841
California
United States
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San Francisco, 94107
California
United States
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Santa Ana, 92705
California
United States
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Santa Barbara, 93103
California
United States
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Torrance, 90509-2910
California
United States
Novartis Investigative Site
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Ventura, 93003
California
United States
Novartis Investigative Site
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Altamonte Springs, 32701
Florida
United States
Novartis Investigative Site
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Deerfield Beach, 33064
Florida
United States
Novartis Investigative Site
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Fort Lauderdale, 33309
Florida
United States
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Fort Myers, 33912-7125
Florida
United States
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Orlando, 32804
Florida
United States
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Pinellas Park, 33782
Florida
United States
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Saint Petersburg, 33711
Florida
United States
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Stuart, 34994
Florida
United States
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Tampa, 33609
Florida
United States
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Winter Haven, 33880
Florida
United States
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Atlanta, 30342
Georgia
United States
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Marietta, 30060
Georgia
United States
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'Aiea, 96701
Hawaii
United States
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Bloomington, 61704
Illinois
United States
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Oak Forest, 60452
Illinois
United States
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Springfield, 62704
Illinois
United States
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Indianapolis, 46280
Indiana
United States
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New Albany, 47150
Indiana
United States
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West Des Moines, 50266
Iowa
United States
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Leawood, 66211
Kansas
United States
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Shawnee Mission, 66204
Kansas
United States
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Hagerstown, 21740
Maryland
United States
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Boston, 02114
Massachusetts
United States
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Royal Oak, 48073
Michigan
United States
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Edina, 55435
Minnesota
United States
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Kansas City, 64133
Missouri
United States
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Reno, 89502
Nevada
United States
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Bloomfield, 07003
New Jersey
United States
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Teaneck, 07666
New Jersey
United States
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Rochester, 14620
New York
United States
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Asheville, 28803
North Carolina
United States
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Charlotte, 28210
North Carolina
United States
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Hickory, 28602
North Carolina
United States
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Southern Pines, 28387
North Carolina
United States
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Cleveland, 44122
Ohio
United States
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Columbus, 43210
Ohio
United States
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Dublin, 43016
Ohio
United States
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Edmond, 73013
Oklahoma
United States
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Eugene, 97401
Oregon
United States
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Portland, 97210
Oregon
United States
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Kingston, 95403
Pennsylvania
United States
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Chattanooga, 37421
Tennessee
United States
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Germantown, 38138
Tennessee
United States
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Abilene, 79606
Texas
United States
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Austin, 78705
Texas
United States
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Austin, 78731
Texas
United States
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Austin, 78793
Texas
United States
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Dallas, 75231
Texas
United States
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Fort Worth, 76104
Texas
United States
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Grapevine, 76051
Texas
United States
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Harlingen, 78550
Texas
United States
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Houston, 77025
Texas
United States
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Houston, 77030
Texas
United States
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San Antonio, 78240
Texas
United States
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Norfolk, 23502
Virginia
United States
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Morgantown, 26506
West Virginia
United States
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Madison, 53705-3611
Wisconsin
United States
Hungary
Novartis Investigative Site
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Pecs, 7621
Baranya
Hungary
Novartis Investigative Site
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Zalaegerszeg, 8900
Zala
Hungary
Novartis Investigative Site
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Budapest, 1083
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Hungary
Novartis Investigative Site
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Debrecen, 4032
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Hungary
Novartis Investigative Site
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Szeged, H 6725
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Hungary
Israel
Novartis Investigative Site
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Haifa, 3339419
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Israel
Novartis Investigative Site
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Haifa, 3436212
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Israel
Novartis Investigative Site
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Kfar Saba, 4428164
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Israel
Novartis Investigative Site
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Petach Tikva, 49100
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Israel
Novartis Investigative Site
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Tel Aviv, 6789140
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Israel
Puerto Rico
Novartis Investigative Site
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Arecibo, 00612
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Puerto Rico
Slovakia
Novartis Investigative Site
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Banska Bystrica, 97517
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Slovakia
Novartis Investigative Site
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Bratislava, 82606
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Slovakia
Novartis Investigative Site
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Bratislava, 85107
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Slovakia
Novartis Investigative Site
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Poprad, 058 45
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Slovakia
Novartis Investigative Site
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Trebisov, 075 01
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Slovakia
Novartis Investigative Site
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Trencin, 91171
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Slovakia
Novartis Investigative Site
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Zvolen, 960 01
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Slovakia

Have a question?

Call 1-999-669-6682 or email [email protected]