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 12, 2022

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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
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

Argentina
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Caba, 1116
Buenos Aires
Argentina
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Ciudad Autonoma de Bs As, C1015ABO
Buenos Aires
Argentina
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Rosario,
Provincia De Santa Fe
Argentina
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Caba,
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Argentina
Australia
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Albury, 2640
New South Wales
Australia
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Liverpool, 2170
New South Wales
Australia
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Parramatta, 2150
New South Wales
Australia
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Strathfield, 2135
New South Wales
Australia
Brazil
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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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Sao Paulo, 01525-001
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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Boisbriand, J7H 1S6
Quebec
Canada
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Quebec, G1S 4L8
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Canada
Chile
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Santiago, 7560994
RM
Chile
China
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Shantou, 515041
Guangdong
China
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Haikou, 570300
Hainan
China
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Wuhan, 430060
Hubei
China
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Wuhan, 430070
Hubei
China
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Nanjing City, 210000
Jiangsu
China
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Nantong, 226000
Jiangsu
China
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Changchun City, 130041
Jilin
China
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Shenyang City, 110000
Liaoning
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Xian, 710004
Shaanxi
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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, 100044
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China
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Beijing, 100050
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China
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Beijing, 100191
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China
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Beijing, 100730
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China
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Chongqing, 400038
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China
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Shanghai, 200080
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China
India
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Ahmedabad, 380016
Gujarat
India
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Coimbatore, 641014
Tamil Nadu
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Tirunelveli, 627003
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DehraDun, 248001
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Chandigarh, 160012
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India
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New Delhi, 110 029
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India
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Nagakute-city, 480-1195
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Sakura, 285-8741
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Yoshida-gun, 910-1193
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Kurume city, 830-0011
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Koriyama, 963-8052
Fukushima
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Asahikawa-city, 078-8510
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Kobe-shi, 650-0017
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Kagoshima city, 890 8520
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Shimotsuke, 329-0498
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Chiyoda-ku, 101-8309
Tokyo
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Hachioji-city, 193-0944
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Meguro-ku, 152-8902
Tokyo
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Shinjuku ku, 162 8666
Tokyo
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Akita, 010-8543
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Japan
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Kyoto, 612-8555
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Japan
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Osaka, 545-8586
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Japan
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Daegu, 705703
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Seoul, 06351
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Mexico
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Philippines
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Ekaterinburg, 620109
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Moscow, 127473
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Moscow, 127486
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Omsk, 644024
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Izmir, 35340
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