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

A Two-year, Three-arm, Randomized, Double-masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Diabetic Macular Edema

ClinicalTrials.gov Identifier: NCT03481634

Novartis Reference Number: CRTH258B2301

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

Condition 
Diabetic Macular Edema
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
571 participants
Start date 
Jul 23, 2018
Completion date 
Oct 14, 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:

Written informed consent before any assessment
Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening
Medication for the management of diabetes stable within 3 months prior to randomization and is expected to remain stable during the course of the study

Exclusion Criteria:

Active proliferative diabetic retinopathy in the study eye
Active intraocular or periocular infection or active intraocular inflammation in study eye
Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 millimeters mercury (mmHg)
Previous treatment with anti-VEGF drugs or investigational drugs in the study eye
Stroke or myocardial infarction during the 6-month period prior to baseline
Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg

Other protocol-specified inclusion/exclusion criteria may apply

Study Locations

United States
Novartis Investigative Site
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Phoenix, 85053
Arizona
United States
Novartis Investigative Site
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Beverly Hills, 90211
California
United States
Novartis Investigative Site
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La Jolla, 92093
California
United States
Novartis Investigative Site
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Mountain View, 94040
California
United States
Novartis Investigative Site
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Santa Barbara, 93103
California
United States
Novartis Investigative Site
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Colorado Springs, 80909
Colorado
United States
Novartis Investigative Site
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Danbury, 06810
Connecticut
United States
Novartis Investigative Site
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Miami, 33136
Florida
United States
Novartis Investigative Site
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Pensacola, 32503
Florida
United States
Novartis Investigative Site
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Stuart, 34994
Florida
United States
Novartis Investigative Site
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'Aiea, 96701
Hawaii
United States
Novartis Investigative Site
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Urbana, 61801
Illinois
United States
Novartis Investigative Site
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Wheaton, 60187
Illinois
United States
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Indianapolis, 46280
Indiana
United States
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New Albany, 47150
Indiana
United States
Novartis Investigative Site
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Leawood, 66211
Kansas
United States
Novartis Investigative Site
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Shawnee Mission, 66204
Kansas
United States
Novartis Investigative Site
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Paducah, 42001
Kentucky
United States
Novartis Investigative Site
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Springfield, 01107
Massachusetts
United States
Novartis Investigative Site
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Stoneham, 02180
Massachusetts
United States
Novartis Investigative Site
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Reno, 89502
Nevada
United States
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Cincinnati, 45242
Ohio
United States
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Cleveland, 44122
Ohio
United States
Novartis Investigative Site
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Cleveland, 44195
Ohio
United States
Novartis Investigative Site
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Kingston, 95403
Pennsylvania
United States
Novartis Investigative Site
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Philadelphia, 19107
Pennsylvania
United States
Novartis Investigative Site
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Memphis, 38119
Tennessee
United States
Novartis Investigative Site
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Nashville, 37232
Tennessee
United States
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Austin, 78705
Texas
United States
Novartis Investigative Site
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Austin, 78731
Texas
United States
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Austin, 78793
Texas
United States
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Harlingen, 78550
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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Tyler, 75701
Texas
United States
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Silverdale, 98383
Washington
United States
Novartis Investigative Site
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Spokane, 99204
Washington
United States
Novartis Investigative Site
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Madison, 53705-3611
Wisconsin
United States
Argentina
Novartis Investigative Site
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Rosario,
Provincia De Santa Fe
Argentina
Novartis Investigative Site
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Caba, 1425
-
Argentina
Novartis Investigative Site
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Caba,
-
Argentina
Novartis Investigative Site
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Ciudad Autonoma de Bs As, C1015ABO
-
Argentina
Novartis Investigative Site
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Cordoba, X5000AAJ
-
Argentina
Australia
Novartis Investigative Site
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Liverpool, 2170
New South Wales
Australia
Novartis Investigative Site
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Parramatta, 2150
New South Wales
Australia
Novartis Investigative Site
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Sydney, 2000
New South Wales
Australia
Novartis Investigative Site
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Westmead, 2145
New South Wales
Australia
Novartis Investigative Site
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Adelaide, 5000
South Australia
Australia
Novartis Investigative Site
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Clayton, 3168
Victoria
Australia
Novartis Investigative Site
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Melbourne, 3002
Victoria
Australia
Novartis Investigative Site
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Nedlands, 6009
Western Australia
Australia
Austria
Novartis Investigative Site
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Graz, A-8036
-
Austria
Novartis Investigative Site
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Innsbruck, 6020
-
Austria
Novartis Investigative Site
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Vienna, 1090
-
Austria
Canada
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Ottawa, K1Z 8R2
Ontario
Canada
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Toronto, M4N 3M5
Ontario
Canada
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Toronto, M5C 2T2
Ontario
Canada
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Quebec, G1S 4L8
-
Canada
Colombia
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Medellin, 001
Antioquia
Colombia
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Medellin,
Antioquia
Colombia
Novartis Investigative Site
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Bogota, 110221
-
Colombia
Israel
Novartis Investigative Site
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Haifa, 3339419
-
Israel
Novartis Investigative Site
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Haifa, 3436212
-
Israel
Novartis Investigative Site
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Haifa, 3525408
-
Israel
Novartis Investigative Site
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Jerusalem, 91120
-
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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Rehovot, 7610001
-
Israel
Novartis Investigative Site
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Tel Aviv, 6423906
-
Israel
Italy
Novartis Investigative Site
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Chieti, 66100
CH
Italy
Novartis Investigative Site
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Catania, 95124
CT
Italy
Novartis Investigative Site
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Milano, 20100
MI
Italy
Novartis Investigative Site
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Milano, 20132
MI
Italy
Novartis Investigative Site
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Padova, 35128
PD
Italy
Novartis Investigative Site
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Roma, 00198
RM
Italy
Japan
Novartis Investigative Site
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Nagoya-city, 462-0825
Aichi
Japan
Novartis Investigative Site
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Nagoya, 455-8530
Aichi
Japan
Novartis Investigative Site
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Nagoya, 457-8511
Aichi
Japan
Novartis Investigative Site
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Nagoya, 466 8560
Aichi
Japan
Novartis Investigative Site
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Kurume-city, 830-8543
Fukuoka
Japan
Novartis Investigative Site
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Amagasaki city, 660 8550
Hyogo
Japan
Novartis Investigative Site
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Tsuchiura, 300-0817
Ibaragi
Japan
Novartis Investigative Site
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Ishioka, 315-0037
Ibaraki
Japan
Novartis Investigative Site
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Kagoshima city, 890 8520
Kagoshima
Japan
Novartis Investigative Site
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Matsumoto-city, 390-8621
Nagano
Japan
Novartis Investigative Site
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Saitama-shi, 336-0963
Saitama
Japan
Novartis Investigative Site
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Shimotsuke, 329-0498
Tochigi
Japan
Novartis Investigative Site
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Chiyoda-ku, 101-8309
Tokyo
Japan
Novartis Investigative Site
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Hachioji-city, 193-0944
Tokyo
Japan
Novartis Investigative Site
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Shinjuku ku, 162 8666
Tokyo
Japan
Novartis Investigative Site
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Taito-ku, 111-0051
Tokyo
Japan
Novartis Investigative Site
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Kumamoto,
-
Japan
Novartis Investigative Site
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Osaka, 543-0027
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Japan
Netherlands
Novartis Investigative Site
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Amsterdam, 1105 AZ
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Netherlands
Novartis Investigative Site
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Rotterdam, 3011 BH
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Netherlands
Novartis Investigative Site
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Tilburg, 5022 GC
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Netherlands
Portugal
Novartis Investigative Site
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Coimbra, 3000-354
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Portugal
Novartis Investigative Site
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Coimbra, 3030-163
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Portugal
Novartis Investigative Site
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Leiria, 2410-187
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Portugal
Novartis Investigative Site
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Porto, 4099-001
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Portugal
Novartis Investigative Site
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Porto, 4200 319
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Portugal
Novartis Investigative Site
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Santa Maria da Feira, 4520 211
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Portugal
Novartis Investigative Site
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Vila Franca de Xira, 2600-009
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Portugal
Puerto Rico
Novartis Investigative Site
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Arecibo, 00612
-
Puerto Rico
Spain
Novartis Investigative Site
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Valladolid, 47011
Castilla Y Leon
Spain
Novartis Investigative Site
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Barcelona, 08036
Catalunya
Spain
Novartis Investigative Site
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Sant Cugat, 08190
Catalunya
Spain
Novartis Investigative Site
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Valencia, 46014
Comunidad Valenciana
Spain
Novartis Investigative Site
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Barcelona, 08025
-
Spain
Novartis Investigative Site
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Santa Cruz de Tenerife, 38009
-
Spain
Novartis Investigative Site
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Zaragoza, 50009
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Spain
United Kingdom
Novartis Investigative Site
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Frimley, GU16 7UJ
Surrey
United Kingdom
Novartis Investigative Site
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Birmingham, B18 7QH
-
United Kingdom
Novartis Investigative Site
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Hull, HU3 2JZ
-
United Kingdom
Novartis Investigative Site
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London, NW10 7NS
-
United Kingdom
Novartis Investigative Site
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Nottingham, NG7 2UH
-
United Kingdom

Have a question?

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