Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
CONDOR
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
1 other identifier
interventional
689
16 countries
120
Brief Summary
The purpose of this study was 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2020
Typical duration for phase_3
120 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
February 20, 2020
CompletedStudy Start
First participant enrolled
November 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2024
CompletedResults Posted
Study results publicly available
August 20, 2024
CompletedOctober 16, 2025
October 1, 2025
2.9 years
February 18, 2020
June 24, 2024
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 54 for the Study Eye
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of \>= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values.
Baseline, Week 54
Secondary Outcomes (12)
Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 54 for the Study Eye
Week 54
Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 96 for the Study Eye
Week 96
Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 54 for the Study Eye
Up to Week 54
Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 96 for the Study Eye
Up to Week 96
Area Under the Curve in Change From Baseline in BCVA up to Week 54 and up to Week 96 - for the Study Eye
Baseline, up to Week 54 and up to Week 96
- +7 more secondary outcomes
Study Arms (2)
Brolucizumab 6 mg
EXPERIMENTALIntra-vitreal injection. 3 x q6w loading injections, followed by q12w maintenance through Week 90
Panretinal photocoagulation laser Arm
ACTIVE COMPARATORInitial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed
Interventions
3 x q6w loading injections, followed by q12w maintenance through Week 90
initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (120)
Retina Associates SW
Tucson, Arizona, 85704, United States
Retina- Vitreous Assoc Medical Group
Beverly Hills, California, 90211, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
Salehi Retina Institute
Huntington Beach, California, 92647, United States
Retina Consultants of Southern California
Redlands, California, 92374, United States
Premiere Practice Management LLC
Torrance, California, 90505, United States
Lundquist Inst BioMed at Harbor
Torrance, California, 90509-2910, United States
Miramar Eye Specialists
Ventura, California, 93003, United States
Advanced Research LLC
Deerfield Beach, Florida, 33064, United States
Rand Eye Institute
Deerfield Beach, Florida, 33064, United States
Pinnacle Research Institute
Fort Lauderdale, Florida, 33309, United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912-7125, United States
Florida Retina Institute
Jacksonville, Florida, 32216, United States
Blue Oc Clin Res at Palm Bch Eye Ct
Lakeland, Florida, 33801, United States
MedEye Associates
Miami, Florida, 33143, United States
Florida Retina Institute
Orlando, Florida, 32804, United States
Eye Center of North Florida
Panama City, Florida, 32405, United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324, United States
Retina Associates
Elmhurst, Illinois, 60126, United States
Midwest Eye Institute
Indianapolis, Indiana, 46280, United States
John-Kenyon American Eye Institute PC
New Albany, Indiana, 47150, United States
Retina Associates PA
Lenexa, Kansas, 66215, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740, United States
University of Mississippi Med Ctr
Jackson, Mississippi, 39216, United States
Retina Associates Of Cleveland
Cleveland, Ohio, 44122, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
Cascade Medical Research Institute
Springfield, Oregon, 97477, United States
Erie Retinal Surgery
Erie, Pennsylvania, 16507, United States
Charleston Neuroscience Institute
Ladson, South Carolina, 29456, United States
Southeastern Retina Associates P C
Knoxville, Tennessee, 37923, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Texan Eye P A
Austin, Texas, 78731, United States
Retina And Vitreous Of Texas
Bellaire, Texas, 77401, United States
Retina Consultants TX Rsrch Ctr
Bellaire, Texas, 77401, United States
Texas Retina Associates
Fort Worth, Texas, 76104, United States
Valley Retina Institute PA
Harlingen, Texas, 78550, United States
Retina Consultants of Houston PA
Houston, Texas, 77030, United States
Medical Center Opthamology Assoc
San Antonio, Texas, 78240, United States
Retina Associates Of South Texas PA
San Antonio, Texas, 78240, United States
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
Novartis Investigative Site
Caba, Buenos Aires, 1116, Argentina
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Ciudad Autonoma de Bs As, Buenos Aires, C1015ABO, Argentina
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Rosario, De Santa Fe, B7602, Argentina
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CABA, C1061AAE, Argentina
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Albury, New South Wales, 2640, Australia
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Liverpool, New South Wales, 2170, Australia
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Parramatta, New South Wales, 2150, Australia
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Strathfield, New South Wales, 2135, Australia
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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
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Blumenau, Santa Catarina, 89052-504, Brazil
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São Paulo, São Paulo, 01427-002, Brazil
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Sorocaba, São Paulo, 18031-060, Brazil
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Ottawa, Ontario, K2B 7E9, Canada
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Toronto, Ontario, M5T 2S8, Canada
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Boisbriand, Quebec, J7H 1S6, Canada
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Québec, Quebec, G1S 4L8, Canada
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Santiago, RM, 7560994, Chile
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Beijing, Beijing Municipality, 100044, China
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Shantou, Guangdong, 515041, China
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Wuhan, Hubei, 430060, China
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Wuhan, Hubei, 430070, China
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Nanjing, Jiangsu, 210000, China
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Nantong, Jiangsu, 226000, China
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Changchun, Jilin, 130041, China
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Shenyang, Liaoning, 110000, China
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Xi'an, Shaanxi, 710004, China
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Chengdu, Sichuan, 610041, China
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Tianjin, Tianjin Municipality, 300020, China
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Wenzhou, Zhejiang, 325027, China
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Beijing, 100050, China
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Beijing, 100191, China
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Beijing, 100730, China
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Shanghai, 200080, China
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Ahmedabad, Gujarat, 380 016, India
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Coimbatore, Tamil Nadu, 641014, India
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Tirunelveli, Tamil Nadu, 627003, India
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Chandigarh, 160012, India
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New Delhi, 110 029, India
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Nagakute, Aichi-ken, 480-1195, Japan
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Nagoya, Aichi-ken, 466 8560, Japan
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Sakura, Chiba, 285-8741, Japan
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Yoshida-gun, Fukui, 910-1193, Japan
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Kurume, Fukuoka, 830-0011, Japan
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Kōriyama, Fukushima, 963-8052, Japan
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Asahikawa, Hokkaido, 078 8510, Japan
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Kita-gun, Kagawa-ken, 761-0793, Japan
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Tsu, Mie-ken, 514-8507, Japan
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Matsumoto, Nagano, 390-8621, Japan
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Shimotsuke, Tochigi, 329-0498, Japan
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Chiyoda-ku, Tokyo, 101-8309, Japan
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Hachiōji, Tokyo, 193-0944, Japan
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Meguro-ku, Tokyo, 152-8902, Japan
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Akita, 010-8543, Japan
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Kobe, 650-0017, Japan
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Osaka, 545-8586, Japan
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Ciudad de, Mexico City, 06800, Mexico
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Mexico City, 06760, Mexico
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Tijuana, 22010, Mexico
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Makati, NCR, 1229, Philippines
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Makati, 1229, Philippines
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Pasig, 1605, Philippines
Emanuelli Research and Development Center LLC
Arecibo, 00612, Puerto Rico
Novartis Investigative Site
Cheboksary, 428028, Russia
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Moscow, 119021, Russia
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Moscow, 127473, Russia
Novartis Investigative Site
Moscow, 127486, Russia
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Omsk, 644024, Russia
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Sterlitamak, 453128, Russia
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Ulyanovsk, 432063, Russia
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Yekaterinburg, 620109, Russia
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Bundang Gu, Gyeonggi-do, 13620, South Korea
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Seoul, Seocho Gu, 06591, South Korea
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Daegu, 705703, South Korea
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Seoul, 06351, South Korea
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Hualien City, 970, Taiwan
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Kaohsiung City, 80756, Taiwan
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Ankara, 06100, Turkey (Türkiye)
Novartis Investigative Site
Ankara, 06230, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, 34420, Turkey (Türkiye)
Novartis Investigative Site
Izmir, 35340, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2020
First Posted
February 20, 2020
Study Start
November 19, 2020
Primary Completion
October 30, 2023
Study Completion
August 19, 2024
Last Updated
October 16, 2025
Results First Posted
August 20, 2024
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.