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

Last updated: February 24, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Diabetic Retinopathy

Diabetic Vitreous Hemorrhage

Retina

Treatment

Panretinal photocoagulation laser

Brolucizumab 6 mg

Clinical Study ID

NCT04278417
CRTH258D2301
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Concomitant conditions or ocular disorders in the study eye at Screening or Baselinethat 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 Design

Total Participants: 689
Treatment Group(s): 2
Primary Treatment: Panretinal photocoagulation laser
Phase: 3
Study Start date:
November 19, 2020
Estimated Completion Date:
August 19, 2024

Study Description

The study is an ongoing, Phase III, 96-week, two-arm, randomized (1:1 ratio), single-masked, multi-center, active-controlled study to evaluate the efficacy and safety of brolucizumab compared to Panretinal photocoagulation (PRP) in subjects with Proliferative diabetic retinopathy (PDR). Subjects who met all the inclusion and none of the exclusion criteria were randomized in a 1:1 ratio to one of the following treatments:

  • Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.

  • PRP: initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment (may split into 2-4 sessions) as needed up to Week 90. Visits occurred every 6 weeks throughout the study, regardless of treatment or not.

Connect with a study center

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, Buenos Aires C1015ABO
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Rosario, De Santa Fe B7602
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Caba, C1061AAE
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Albury, New South Wales 2640
    Australia

    Site Not Available

  • Novartis Investigative Site

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Novartis Investigative Site

    Parramatta, New South Wales 2150
    Australia

    Site Not Available

  • Novartis Investigative Site

    Strathfield, New South Wales 2135
    Australia

    Site Not Available

  • Novartis Investigative Site

    Porto Alegre, RS 90035-903
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Blumenau, SC 89052-504
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sao Paulo, SP 01427-002
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sorocaba, SP 18031-060
    Brazil

    Site Not Available

  • Novartis Investigative Site

    São Paulo, SP 01525-001
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Ottawa, Ontario K2B 7E9
    Canada

    Site Not Available

  • Novartis Investigative Site

    Toronto, Ontario M5T 2S8
    Canada

    Site Not Available

  • Novartis Investigative Site

    Boisbriand, Quebec J7H 1S6
    Canada

    Site Not Available

  • Novartis Investigative Site

    Quebec, G1S 4L8
    Canada

    Site Not Available

  • Novartis Investigative Site

    Santiago, RM 7560994
    Chile

    Site Not Available

  • Novartis Investigative Site

    Shantou, Guangdong 515041
    China

    Site Not Available

  • Novartis Investigative Site

    Haikou, Hainan 570300
    China

    Site Not Available

  • Novartis Investigative Site

    Wuhan, Hubei 430060
    China

    Site Not Available

  • Novartis Investigative Site

    Nanjing City, Jiangsu 210000
    China

    Site Not Available

  • Novartis Investigative Site

    Nantong, Jiangsu 226000
    China

    Site Not Available

  • Novartis Investigative Site

    Changchun, Jilin 130041
    China

    Site Not Available

  • Novartis Investigative Site

    Changchun City, Jilin 130041
    China

    Site Not Available

  • Novartis Investigative Site

    Shenyang City, Liaoning 110000
    China

    Site Not Available

  • Novartis Investigative Site

    Xian, Shaanxi 710004
    China

    Site Not Available

  • Novartis Investigative Site

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Novartis Investigative Site

    Tianjin, Tianjin 300020
    China

    Site Not Available

  • Novartis Investigative Site

    Wenzhou, Zhejiang 325027
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing, 100050
    China

    Site Not Available

  • Novartis Investigative Site

    Chongqing, 400038
    China

    Site Not Available

  • Novartis Investigative Site

    Shanghai, 200080
    China

    Site Not Available

  • Novartis Investigative Site

    Ahmedabad, Gujarat 380016
    India

    Site Not Available

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu 641014
    India

    Site Not Available

  • Novartis Investigative Site

    Tirunelveli, Tamilnadu 627003
    India

    Site Not Available

  • Novartis Investigative Site

    DehraDun, Uttarakhand 248001
    India

    Site Not Available

  • Novartis Investigative Site

    Chandigarh, 160012
    India

    Site Not Available

  • Novartis Investigative Site

    New Delhi, 110 029
    India

    Site Not Available

  • Novartis Investigative Site

    Nagakute-city, Aichi 480-1195
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nagoya, Aichi 466 8560
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sakura, Chiba 285-8741
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yoshida-gun, Fukui 910-1193
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kurume city, Fukuoka 830-0011
    Japan

    Site Not Available

  • Novartis Investigative Site

    Koriyama, Fukushima 963-8052
    Japan

    Site Not Available

  • Novartis Investigative Site

    Asahikawa, Hokkaido 078 8510
    Japan

    Site Not Available

  • Novartis Investigative Site

    Asahikawa-city, Hokkaido 078-8510
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kita-gun, Kagawa 761-0793
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kagoshima city, Kagoshima 890 8520
    Japan

    Site Not Available

  • Novartis Investigative Site

    Tsu-city, Mie 514-8507
    Japan

    Site Not Available

  • Novartis Investigative Site

    Matsumoto, Nagano 390-8621
    Japan

    Site Not Available

  • Novartis Investigative Site

    Matsumoto-city, Nagano 390-8621
    Japan

    Site Not Available

  • Novartis Investigative Site

    Shimotsuke, Tochigi 329-0498
    Japan

    Site Not Available

  • Novartis Investigative Site

    Chiyoda-ku, Tokyo 101-8309
    Japan

    Site Not Available

  • Novartis Investigative Site

    Hachioji-city, Tokyo 193-0944
    Japan

    Site Not Available

  • Novartis Investigative Site

    Meguro-ku, Tokyo 152-8902
    Japan

    Site Not Available

  • Novartis Investigative Site

    Shinjuku ku, Tokyo 162 8666
    Japan

    Site Not Available

  • Novartis Investigative Site

    Akita, 010-8543
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kobe-shi, 650-0017
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kyoto, 612-8555
    Japan

    Site Not Available

  • Novartis Investigative Site

    Osaka, 545-8586
    Japan

    Site Not Available

  • Novartis Investigative Site

    Bundang Gu, Gyeonggi Do 13620
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Seoul, Seocho Gu 06591
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Daegu, 705703
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Ciudad De, Distrito Federal 06800
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Ciudad De Mexico, Distrito Federal 06800
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Guadalajara, Jalisco 44160
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Ciudad de Mexico, 06760
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Tijuana, 22010
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Makati, 1229
    Philippines

    Site Not Available

  • Novartis Investigative Site

    Pasig City, 1605
    Philippines

    Site Not Available

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612
    Puerto Rico

    Site Not Available

  • Novartis Investigative Site

    Arecibo, 00612
    Puerto Rico

    Site Not Available

  • Novartis Investigative Site

    Cheboksary, 428028
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Ekaterinburg, 620109
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Kazan, 420012
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Kirov, 610027
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Moscow, 127486
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Omsk, 644024
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Sterlitamak, 453128
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Ulyanovsk, 432063
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Hualien, 970
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Kaohsiung, 80756
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Ankara, 06100
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Istanbul, 34420
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Izmir, 35340
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Retina Associates SW

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Novartis Investigative Site

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Retina Vitreous Assoc Medical Group .

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Retina- Vitreous Assoc Medical Group .

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Novartis Investigative Site

    Fullerton, California 92835
    United States

    Site Not Available

  • Retina Consultants of Orange County

    Fullerton, California 92835
    United States

    Site Not Available

  • Novartis Investigative Site

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Salehi Retina Institute

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Novartis Investigative Site

    Loma Linda, California 92354
    United States

    Site Not Available

  • Novartis Investigative Site

    Rancho Cordova, California 95670
    United States

    Site Not Available

  • Novartis Investigative Site

    Redlands, California 92374
    United States

    Site Not Available

  • Retina Consultants of Southern California .

    Redlands, California 92374
    United States

    Site Not Available

  • Novartis Investigative Site

    Sacramento, California 95817
    United States

    Site Not Available

  • Lundquist Inst BioMed at Harbor .

    Torrance, California 90509-2910
    United States

    Site Not Available

  • Novartis Investigative Site

    Torrance, California 90505
    United States

    Site Not Available

  • Premiere Practice Management LLC

    Torrance, California 90505
    United States

    Site Not Available

  • Novartis Investigative Site

    Ventura, California 93003
    United States

    Site Not Available

  • Novartis Investigative Site

    Altamonte Springs, Florida 32701
    United States

    Site Not Available

  • Advanced Research LLC

    Coral Springs, Florida 33067
    United States

    Site Not Available

  • Novartis Investigative Site

    Coral Springs, Florida 33067
    United States

    Site Not Available

  • Advanced Research LLC

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Novartis Investigative Site

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Rand Eye Institute

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Novartis Investigative Site

    Fort Lauderdale, Florida 33309
    United States

    Site Not Available

  • National Ophthalmic Research Institute Ophthalmology

    Fort Myers, Florida 33912-7125
    United States

    Site Not Available

  • Novartis Investigative Site

    Fort Myers, Florida 33912-7125
    United States

    Site Not Available

  • Florida Retina Institute

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Novartis Investigative Site

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Novartis Investigative Site

    Lakeland, Florida 33801
    United States

    Site Not Available

  • MedEye Associates Ophthalmology

    Miami, Florida 33143
    United States

    Site Not Available

  • Novartis Investigative Site

    Miami, Florida 33143
    United States

    Site Not Available

  • Florida Retina Institute Ophthalmology

    Orlando, Florida 32804
    United States

    Site Not Available

  • Novartis Investigative Site

    Orlando, Florida 32804
    United States

    Site Not Available

  • Eye Center of North Florida

    Panama City, Florida 32405
    United States

    Site Not Available

  • Novartis Investigative Site

    Panama City, Florida 32405
    United States

    Site Not Available

  • Fort Lauderdale Eye Institute .

    Plantation, Florida 33324
    United States

    Site Not Available

  • Novartis Investigative Site

    Plantation, Florida 33324
    United States

    Site Not Available

  • Novartis Investigative Site

    Vero Beach, Florida 32960
    United States

    Site Not Available

  • Novartis Investigative Site

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Novartis Investigative Site

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Novartis Investigative Site

    Elmhurst, Illinois 60126
    United States

    Site Not Available

  • Retina Associates

    Elmhurst, Illinois 60126
    United States

    Site Not Available

  • Midwest Eye Institute .

    Indianapolis, Indiana 46280
    United States

    Site Not Available

  • Novartis Investigative Site

    Indianapolis, Indiana 46280
    United States

    Site Not Available

  • John-Kenyon American Eye Institute PC

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Novartis Investigative Site

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Novartis Investigative Site

    Lenexa, Kansas 66215
    United States

    Site Not Available

  • Retina Associates PA

    Lenexa, Kansas 66215
    United States

    Site Not Available

  • Novartis Investigative Site

    Shawnee Mission, Kansas 66204
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Novartis Investigative Site

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Novartis Investigative Site

    Hattiesburg, Mississippi 39402
    United States

    Site Not Available

  • Novartis Investigative Site

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • University of Mississippi Med Ctr .

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Novartis Investigative Site

    Kansas City, Missouri 64133
    United States

    Site Not Available

  • Novartis Investigative Site

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Retina Associates Of Cleveland .

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Dean McGee Eye Institute

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Novartis Investigative Site

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Cascade Medical Research Institute

    Springfield, Oregon 97477
    United States

    Site Not Available

  • Novartis Investigative Site

    Springfield, Oregon 97477
    United States

    Site Not Available

  • Erie Retinal Surgery

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • Novartis Investigative Site

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • Novartis Investigative Site

    Monroeville, Pennsylvania 15146
    United States

    Site Not Available

  • Novartis Investigative Site

    West Mifflin, Pennsylvania 15122
    United States

    Site Not Available

  • Charleston Neuroscience Institute

    Ladson, South Carolina 29456
    United States

    Site Not Available

  • Novartis Investigative Site

    Ladson, South Carolina 29456
    United States

    Site Not Available

  • Novartis Investigative Site

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Novartis Investigative Site

    Knoxville, Tennessee 37923
    United States

    Site Not Available

  • Southeastern Retina Associates P C .

    Knoxville, Tennessee 37923
    United States

    Site Not Available

  • Southeastern Retina Associates P C Southeastern Retina Assoc PC-

    Knoxville, Tennessee 37923
    United States

    Site Not Available

  • Austin Retina Associates

    Austin, Texas 78705
    United States

    Site Not Available

  • Novartis Investigative Site

    Austin, Texas 78731
    United States

    Site Not Available

  • Texan Eye P A

    Austin, Texas 78731
    United States

    Site Not Available

  • Novartis Investigative Site

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Retina And Vitreous Of Texas Ophthalmology 3

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Retina Consultants TX Rsrch Ctr

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Novartis Investigative Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Texas Retina Associates

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Novartis Investigative Site

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Valley Retina Institute PA .

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Novartis Investigative Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Retina Consultants of Houston PA .

    Houston, Texas 77030
    United States

    Site Not Available

  • Medical Center Opthamology Assoc .

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Medical Center Opthamology Associates .

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Novartis Investigative Site

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Retina Associates Of South Texas PA CRFB002H2301

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Novartis Investigative Site

    Tyler, Texas 75701
    United States

    Site Not Available

  • Novartis Investigative Site

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Virginia Eye Consultants

    Norfolk, Virginia 23502
    United States

    Site Not Available

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