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

ClinicalTrials.gov Identifier: NCT03810313

Novartis Reference Number: CRTH258C2302

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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 central retinal vein occlusion (CRVO).

Condition 
Central Retinal Vein Occlusion
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
750 participants
Start date 
Jul 03, 2019
Completion date 
Feb 07, 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

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 CRVO 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 CRVO, retinal detachment, macular hole, or choroidal neovascularization of any cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular edema).
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
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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
Withdrawn
Oakland, 94609
California
United States
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Oakland, 94609
California
United States
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Orange, 92868
California
United States
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Palo Alto, 94303
California
United States
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Santa Barbara, 93103
California
United States
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Colorado Springs, 80909
Colorado
United States
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Fort Myers, 33912-7125
Florida
United States
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Pensacola, 32503
Florida
United States
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Saint Petersburg, 33711
Florida
United States
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Marietta, 30060
Georgia
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
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Shawnee Mission, 66204
Kansas
United States
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New Orleans, 70115-8139
Louisiana
United States
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Stoneham, 02180
Massachusetts
United States
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Edina, 55435
Minnesota
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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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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Cleveland, 44195
Ohio
United States
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Monroeville, 15146
Pennsylvania
United States
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Memphis, 38119
Tennessee
United States
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Nashville, 37203
Tennessee
United States
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Abilene, 79606
Texas
United States
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Arlington, 76012
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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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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Madison, 53705-3611
Wisconsin
United States
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Milwaukee, 53226
Wisconsin
United States
Australia
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Albury, 2640
New South Wales
Australia
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Parramatta, 2150
New South Wales
Australia
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Strathfield, 2135
New South Wales
Australia
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Sydney, 2000
New South Wales
Australia
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Hobart, 7000
Tasmania
Australia
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Melbourne, 3002
Victoria
Australia
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Nedlands, 6009
Western Australia
Australia
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
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Canada
China
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Guangzhou, 510060
Guangdong
China
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Wuhan, 430070
Hubei
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
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China
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Shanghai, 200080
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China
Czechia
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Hradec Kralove, 505 05
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Czechia
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Praha 10, 100 34
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Czechia
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Praha, 12808
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Czechia
Finland
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Kuopio, 70211
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Finland
France
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Creteil, 94000
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France
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Dijon, 21034
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France
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Ecully, 69130
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France
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Lyon CEDEX 04, 69317
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France
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Nantes Cedex 1, 44093
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France
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Nantes, 44000
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France
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Paris cedex 10, 75010
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France
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Paris Cedex 19, 75940
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France
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Strasbourg Cedex, 67091
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France
Germany
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Regensburg, 93053
Bavaria
Germany
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Duesseldorf, 40225
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Germany
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Freiburg, 79106
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Germany
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Gottingen, 37075
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Germany
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Hannover, 30625
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Germany
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Heidelberg, 69120
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Germany
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Leipzig, 04103
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Germany
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Muenchen, 81675
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Germany
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Muenster, 48145
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Germany
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Ulm, 89075
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Germany
Greece
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Larissa, 411 10
GR
Greece
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Heraklion Crete, 711 10
-
Greece
Hungary
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Budapest, 1083
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Hungary
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Debrecen, 4012
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Hungary
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Szeged, H 6725
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Hungary
Israel
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Jerusalem, 91120
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Israel
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Petach Tikva, 49100
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Israel
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Rehovot, 7610001
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Israel
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Tel Aviv, 6423906
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Israel
Italy
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Milano, 20100
MI
Italy
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Milano, 20122
MI
Italy
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Milano, 20132
MI
Italy
Japan
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Nagakute-city, 480-1195
Aichi
Japan
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Nagoya-city, 467-8602
Aichi
Japan
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Tsu-city, 514-8507
Mie
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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Hachioji-city, 193-0944
Tokyo
Japan
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Taito-ku, 111-0051
Tokyo
Japan
Malaysia
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Batu Caves, 68100
Selangor
Malaysia
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Shah Alam, 40000
Selangor
Malaysia
Netherlands
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Amsterdam, 1081
-
Netherlands
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Rotterdam, 3079 DZ
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Netherlands
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Tilburg, 5022 GC
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Netherlands
Puerto Rico
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Arecibo, 00612
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Puerto Rico
Russian Federation
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Ekaterinburg, 620109
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Russian Federation
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Kazan, 420066
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Russian Federation
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St-Petersburg, 197022
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Russian Federation
Spain
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San Sebastian, 20080
Pais Vasco
Spain
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Barcelona, 08025
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Spain
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Barcelona, 8022
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Spain
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Madrid, 28046
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Spain
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Valencia, 46004
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Spain
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Zaragoza, 50009
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Spain
Thailand
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Songkhla, 90110
Hat Yai
Thailand
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Khon Kaen, 40002
THA
Thailand
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Bangkok, 10330
-
Thailand
United Kingdom
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Colchester, CO4 5JL
Essex
United Kingdom
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Bury Saint Edmonds, IP33 2QZ
Suffolk
United Kingdom
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Derby, DE22 3NE
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United Kingdom
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Leeds, LS9 7TF
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United Kingdom
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Liverpool, L7 8XP
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United Kingdom
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London, EC1V 2PD
-
United Kingdom
Novartis Investigative Site
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Newcastle Upon Tyne, NE1 4LP
-
United Kingdom

Contacts

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

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