Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion

An Eighteen-Month, Two-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 Macular Edema Secondary to Branch Retinal Vein Occlusion

ClinicalTrials.gov Identifier: NCT03802630

Novartis Reference Number: CRTH258C2301

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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 macular edema (ME) secondary to branch retinal vein occlusion (BRVO).

Condition 
Branch Retinal Vein Occlusion
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
500 participants
Start date 
Jul 02, 2019
Completion date 
May 26, 2023
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Brolucizumab 6 mg
Solution for injection (intravitreal use)
Drug
Aflibercept 2 mg
Solution for injection (Intravitreal use)
Other
Sham injection
Empty sterile syringe without a needle administered as a sham injection for masking purposes

Eligibility Criteria

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study.
Patients with visual impairment due to ME secondary to BRVO diagnosed < 6 months prior to screening.
BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/320) at both screening and baseline visits.

Exclusion criteria

Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the first 12-month study period (e.g. structural damage of the fovea, vitreous hemorrhage, retinal vascular occlusion other than BRVO, retinal detachment, macular hole, or choroidal neovascularization of any cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular edema). Hemiretinal vein occlusion should be excluded.
Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline
Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator's judgment, at screening or baseline
Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 20/200 at screening (except when due to conditions whose surgery may improve VA, e.g. cataract)
Previous treatment with any anti-VEGF therapy or investigational drugs in the study eye at any time prior to baseline
Previous use of intraocular or periocular steroids in study eye at any time prior to baseline
Macular laser photocoagulation (focal/grid) in the study eye at any time prior to baseline and peripheral laser photocoagulation in the study eye within 3 months prior to the baseline
Intraocular surgery in the study eye during the 3-month period prior to baseline
Vitreoretinal surgery in the study eye at any time prior to baseline
Aphakia with the absence of posterior capsule in the study eye

Study Locations

United States
Novartis Investigative Site
Recruiting
Phoenix, 85020
Arizona
United States
Novartis Investigative Site
Recruiting
Mountain View, 94040
California
United States
Novartis Investigative Site
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Orange, 92868
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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Pensacola, 32503
Florida
United States
Novartis Investigative Site
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Saint Petersburg, 33711
Florida
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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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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New Orleans, 70115-8139
Louisiana
United States
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Stoneham, 02180
Massachusetts
United States
Novartis Investigative Site
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Reno, 89502
Nevada
United States
Novartis Investigative Site
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Bloomfield, 07003
New Jersey
United States
Novartis Investigative Site
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Asheville, 28803
North Carolina
United States
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Charlotte, 28210
North Carolina
United States
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Cleveland, 44122
Ohio
United States
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Monroeville, 15146
Pennsylvania
United States
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Abilene, 79606
Texas
United States
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Arlington, 76012
Texas
United States
Novartis Investigative Site
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Austin, 78731
Texas
United States
Novartis Investigative Site
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Austin, 78793
Texas
United States
Novartis Investigative Site
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Houston, 77025
Texas
United States
Novartis Investigative Site
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Houston, 77030
Texas
United States
Novartis Investigative Site
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San Antonio, 78240
Texas
United States
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Madison, 53705-3611
Wisconsin
United States
Austria
Novartis Investigative Site
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Graz, A-8036
-
Austria
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Linz, A 4020
-
Austria
Novartis Investigative Site
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Vienna, 1140
-
Austria
Canada
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Calgary, T2H0C8
Alberta
Canada
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London, N6A 4V2
Ontario
Canada
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Ottawa, K1H 8L6
Ontario
Canada
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Ottawa, K1Z 8R2
Ontario
Canada
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Toronto, M5T 2S8
Ontario
Canada
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Quebec, G1S 4L8
-
Canada
China
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Guangzhou, 510060
Guangdong
China
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Wuhan, 430070
Hubei
China
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Wuxi,
Jiangsu
China
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Chengdu, 610041
Sichuan
China
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Tianjin, 300020
Tianjin
China
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Tianjin, 300070
Tianjin
China
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Wenzhou, 325027
Zhejiang
China
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Beijing, 100730
-
China
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Chongqing, 400038
-
China
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Shanghai, 200080
-
China
Denmark
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Copenhagen, 2100
-
Denmark
France
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Saint Cys Sur Loire, 37540
Indre Et Loire
France
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Bordeaux, 33000
-
France
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Creteil, 94000
-
France
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Marseille, F 13008
-
France
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Paris cedex 10, 75010
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France
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Paris, 75015
-
France
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Strasbourg, 67000
-
France
Germany
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Regensburg, 93053
Bavaria
Germany
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Bonn, 53105
-
Germany
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Düsseldorf, 40212
-
Germany
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Freiburg, 79106
-
Germany
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Glauchau, 08371
-
Germany
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Gottingen, 37075
-
Germany
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Hamburg, 20246
-
Germany
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Koeln, 50924
-
Germany
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Leipzig, 04103
-
Germany
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Ludwigshafen, 67063
-
Germany
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Mainz, 55131
-
Germany
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Muenster, 48145
-
Germany
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Ulm, 89075
-
Germany
Hong Kong
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Hongkong,
-
Hong Kong
Israel
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Jerusalem, 91031
-
Israel
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Zerifin, 6093000
-
Israel
Italy
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Catania, 95123
CT
Italy
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Roma, 00198
RM
Italy
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Recruiting
Udine, 33100
UD
Italy
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Roma, 00133
-
Italy
Japan
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Nagoya-city, 467-8602
Aichi
Japan
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Amagasaki city, 660 8550
Hyogo
Japan
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Ishioka, 315-0037
Ibaraki
Japan
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Matsumoto-city, 390-8621
Nagano
Japan
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Chiyoda-ku, 101-8309
Tokyo
Japan
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Taito-ku, 111-0051
Tokyo
Japan
Puerto Rico
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Arecibo, 00612
-
Puerto Rico
Russian Federation
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Cheboksary, 428028
-
Russian Federation
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Moscow, 119021
-
Russian Federation
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Saratov, 410012
-
Russian Federation
Slovakia
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Recruiting
Bratislava, 85107
-
Slovakia
Novartis Investigative Site
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Nitra, 950 01
-
Slovakia
Spain
Novartis Investigative Site
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Sevilla, 41009
Andalucia
Spain
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Sant Cugat, 08190
Catalunya
Spain
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Santiago de Compostela, 15706
Galicia
Spain
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Barcelona, 08021
-
Spain
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Madrid, 28040
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Spain
Switzerland
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Lausanne, 1006
Vaud
Switzerland
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Binningen, 4102
-
Switzerland
Taiwan
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Changhua, 50006
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Taiwan
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Taipei, 10002
-
Taiwan
United Kingdom
Novartis Investigative Site
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Westcliff-on-Sea, SS0 0RY
Essex
United Kingdom
Novartis Investigative Site
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Bradford, BD9 6RJ
West Yorkshire
United Kingdom
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Birmingham, B18 7QH
-
United Kingdom
Novartis Investigative Site
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Cheshire, CW1 4QJ
-
United Kingdom
Novartis Investigative Site
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Liverpool, L7 8XP
-
United Kingdom
Novartis Investigative Site
Recruiting
London, NW3 2QG
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

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