Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

A 96-week, Two-arm, Randomized, Single-masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

ClinicalTrials.gov Identifier: NCT04278417

Novartis Reference Number: CRTH258D2301

Last Update: Aug 30, 2021

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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 compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.

Condition 
Proliferative Diabetic Retinopathy
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
706 participants
Start date 
Nov 19, 2020
Completion date 
Jan 10, 2025
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Biological
Brolucizumab 6 mg
3 x q6w loading injections, followed by q12w maintenance through Week 90
Procedure
Panretinal photocoagulation laser
initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed

Eligibility Criteria

Inclusion Criteria:

Signed informed consent must be obtained prior to participation
Able to complete adequate fundus photographs and retinal images
Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening
DM treatment stable for at least 3 months
PDR diagnosis with no previous PRP treatment in the study eye

Exclusion Criteria:

Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment.
Presence of diabetic macular edema in the study eye Active infection or inflammation in the study eye
Uncontrolled glaucoma (IOP greater than 25 mmHg)
Intravitreal anti-VEGF treatment within 6 months
Treatment with intraocular corticosteroids
End stage renal disease requiring dialysis or kidney transplant
Uncontrolled blood pressure
Systemic anti-VEGF therapy at any time Other protocol-defined inclusion/exclusion criteria may apply -

Study Locations

United States
Novartis Investigative Site
Recruiting
Beverly Hills, 90211
California
United States
Novartis Investigative Site
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Fullerton, 92835
California
United States
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Huntington Beach, 92647
California
United States
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Loma Linda, 92354
California
United States
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Rancho Cordova, 95670
California
United States
Novartis Investigative Site
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Redlands, 92374
California
United States
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Sacramento, 95817
California
United States
Novartis Investigative Site
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Torrance, 90505
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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Coral Springs, 33067
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
Novartis Investigative Site
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Fort Myers, 33912-7125
Florida
United States
Novartis Investigative Site
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Jacksonville, 32216
Florida
United States
Novartis Investigative Site
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Lakeland, 33801
Florida
United States
Novartis Investigative Site
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Miami, 33126
Florida
United States
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Miami, 33143
Florida
United States
Novartis Investigative Site
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Orlando, 32804
Florida
United States
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Panama City, 32405
Florida
United States
Novartis Investigative Site
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Plantation, 33324
Florida
United States
Novartis Investigative Site
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Winter Haven, 33880
Florida
United States
Novartis Investigative Site
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Atlanta, 30342
Georgia
United States
Novartis Investigative Site
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Elmhurst, 60126
Illinois
United States
Novartis Investigative Site
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Indianapolis, 46280
Indiana
United States
Novartis Investigative Site
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New Albany, 47150
Indiana
United States
Novartis Investigative Site
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Lenexa, 66215
Kansas
United States
Novartis Investigative Site
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Hagerstown, 21740
Maryland
United States
Novartis Investigative Site
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Hattiesburg, 39402
Mississippi
United States
Novartis Investigative Site
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Kansas City, 64133
Missouri
United States
Novartis Investigative Site
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Cleveland, 44122
Ohio
United States
Novartis Investigative Site
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Oklahoma City, 73104
Oklahoma
United States
Novartis Investigative Site
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Springfield, 97477
Oregon
United States
Novartis Investigative Site
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Erie, 16507
Pennsylvania
United States
Novartis Investigative Site
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Monroeville, 15146
Pennsylvania
United States
Novartis Investigative Site
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West Mifflin, 15122
Pennsylvania
United States
Novartis Investigative Site
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Ladson, 29456
South Carolina
United States
Novartis Investigative Site
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Germantown, 38138
Tennessee
United States
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Knoxville, 37923
Tennessee
United States
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Austin, 78705
Texas
United States
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Austin, 78731
Texas
United States
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Bellaire, 77401
Texas
United States
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Fort Worth, 76104
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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Tyler, 75701
Texas
United States
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Norfolk, 23502
Virginia
United States
Australia
Novartis Investigative Site
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Albury, 2640
New South Wales
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
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Strathfield, 2135
New South Wales
Australia
Brazil
Novartis Investigative Site
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Porto Alegre, 90035-903
RS
Brazil
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Blumenau, 89052-504
SC
Brazil
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Sao Paulo, 01427-002
SP
Brazil
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Sorocaba, 18031-060
SP
Brazil
Canada
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Ottawa, K2B 7E9
Ontario
Canada
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Toronto, M5T 2S8
Ontario
Canada
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Quebec, G1S 4L8
-
Canada
China
Novartis Investigative Site
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Changchun City, 130041
Jilin
China
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Xian, 710004
Shaanxi
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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Beijing, 100050
-
China
Novartis Investigative Site
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Beijing, 100730
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China
India
Novartis Investigative Site
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Ahmedabad, 380016
Gujarat
India
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Chandigarh, 160012
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India
Japan
Novartis Investigative Site
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Nagoya, 466 8560
Aichi
Japan
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Sakura, 285-8741
Chiba
Japan
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Koriyama, 963-8052
Fukushima
Japan
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Asahikawa-city, 078-8510
Hokkaido
Japan
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Kobe-shi, 650-0017
Hyogo
Japan
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Kita-gun, 761-0793
Kagawa
Japan
Novartis Investigative Site
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Kagoshima city, 890 8520
Kagoshima
Japan
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Tsu-city, 514-8507
Mie
Japan
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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
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Meguro-ku, 152-8902
Tokyo
Japan
Novartis Investigative Site
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Kyoto, 612-8555
-
Japan
Korea, Republic of
Novartis Investigative Site
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Bundang Gu, 13620
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
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Seoul, 06591
Seocho Gu
Korea, Republic of
Novartis Investigative Site
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Daegu, 705703
-
Korea, Republic of
Novartis Investigative Site
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Seoul, 06351
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Korea, Republic of
Philippines
Novartis Investigative Site
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Makati, 1229
NCR
Philippines
Novartis Investigative Site
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Makati, 1229
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Philippines
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Pasig City, 1605
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Philippines
Puerto Rico
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Arecibo, 00612
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Puerto Rico
Russian Federation
Novartis Investigative Site
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Cheboksary, 428028
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Russian Federation
Novartis Investigative Site
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Ekaterinburg, 620109
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Russian Federation
Novartis Investigative Site
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Kazan, 420012
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Russian Federation
Novartis Investigative Site
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Kazan, 420066
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Russian Federation
Novartis Investigative Site
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Moscow, 127486
-
Russian Federation
Novartis Investigative Site
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Omsk, 644024
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Russian Federation
Novartis Investigative Site
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Sterlitamak, 453128
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Russian Federation
Taiwan
Novartis Investigative Site
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Hualien, 970
-
Taiwan
Novartis Investigative Site
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Kaohsiung, 80756
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Taiwan
Turkey
Novartis Investigative Site
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Ankara, 06100
-
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06500
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
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Novartis Pharmaceuticals
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