Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
KESTREL
A Two-year, Three-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 Diabetic Macular Edema
2 other identifiers
interventional
566
13 countries
108
Brief Summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2018
Typical duration for phase_3
108 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
March 13, 2018
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedStudy Start
First participant enrolled
July 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2021
CompletedResults Posted
Study results publicly available
October 28, 2022
CompletedJanuary 30, 2023
January 1, 2023
2.3 years
March 13, 2018
May 27, 2022
January 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52
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 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning. This endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.
Baseline, Week 52
Secondary Outcomes (33)
Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52
Baseline and Week 40 through Week 52 (average)
Patients Maintained at q12w - Probability of Maintaining on q12w
Baseline (Week 0), Weeks 32, 36 and 48
Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w
Weeks 36 and 48
Change From Baseline in BCVA at Each Visit up to Week 52
Baseline (Week 0), Weeks 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52
BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF)
Baseline, and Week 88 through Week 100 (average)
- +28 more secondary outcomes
Study Arms (3)
Brolucizumab 3 mg
EXPERIMENTALBrolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule. To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP).
Brolucizumab 6 mg
EXPERIMENTALBrolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule. To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP).
Aflibercept 2 mg
ACTIVE COMPARATORAflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks. To fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP).
Interventions
Intravitreal injection
Eligibility Criteria
You may qualify if:
- Written informed consent before any assessment
- Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening
- Medication for the management of diabetes stable within 3 months prior to randomization and is expected to remain stable during the course of the study
You may not qualify if:
- Active proliferative diabetic retinopathy in the study eye
- Active intraocular or periocular infection or active intraocular inflammation in study eye
- Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 millimeters mercury (mmHg)
- Previous treatment with anti-VEGF drugs or investigational drugs in the study eye
- Stroke or myocardial infarction during the 6-month period prior to baseline
- Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (116)
Novartis Investigative Site
Phoenix, Arizona, 85053, United States
Novartis Investigative Site
Beverly Hills, California, 90211, United States
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La Jolla, California, 92093, United States
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Mountain View, California, 94040, United States
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Santa Barbara, California, 93103, United States
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Colorado Springs, Colorado, 80909, United States
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Danbury, Connecticut, 06810, United States
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Miami, Florida, 33136, United States
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Pensacola, Florida, 32503, United States
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Stuart, Florida, 34994, United States
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‘Aiea, Hawaii, 96701, United States
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Urbana, Illinois, 61801, United States
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Wheaton, Illinois, 60187, United States
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Indianapolis, Indiana, 46280, United States
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New Albany, Indiana, 47150, United States
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Leawood, Kansas, 66211, United States
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Lenexa, Kansas, 66215, United States
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Paducah, Kentucky, 42001, United States
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Springfield, Massachusetts, 01107, United States
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Stoneham, Massachusetts, 02180, United States
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Reno, Nevada, 89502, United States
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Cincinnati, Ohio, 45242, United States
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Cleveland, Ohio, 44122, United States
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Cleveland, Ohio, 44195, United States
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Kingston, Pennsylvania, 95403, United States
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Philadelphia, Pennsylvania, 19107, United States
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Memphis, Tennessee, 38119, United States
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Nashville, Tennessee, 37232, United States
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Austin, Texas, 78705, United States
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Austin, Texas, 78731, United States
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Austin, Texas, 78750, United States
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Bellaire, Texas, 77401, United States
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Harlingen, Texas, 78550, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78240, United States
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Tyler, Texas, 75701, United States
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Silverdale, Washington, 98383, United States
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Spokane, Washington, 99204, United States
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Madison, Wisconsin, 53705-3611, United States
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Ciudad Autonoma de Bs As, Buenos Aires, C1015ABO, Argentina
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Rosario, Santa Fe Province, Argentina
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CABA, 1425, Argentina
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CABA, Argentina
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Córdoba, X5000AAJ, Argentina
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Liverpool, New South Wales, 2170, Australia
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Parramatta, New South Wales, 2150, Australia
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Sydney, New South Wales, 2000, Australia
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Westmead, New South Wales, 2145, Australia
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Adelaide, South Australia, 5000, Australia
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Clayton, Victoria, 3168, Australia
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Melbourne, Victoria, 3002, Australia
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Nedlands, Western Australia, 6009, Australia
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Graz, A-8036, Austria
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Innsbruck, 6020, Austria
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Vienna, 1090, Austria
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Ottawa, Ontario, K1Z 8R2, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5C 2T2, Canada
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Québec, G1S 4L8, Canada
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Medellín, Antioquia, 001, Colombia
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Medellín, Antioquia, Colombia
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Bogotá, 110221, Colombia
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Haifa, 3109601, Israel
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Haifa, 3339419, Israel
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Haifa, 3436212, Israel
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Jerusalem, 9112001, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 4941492, Israel
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Rehovot, 7610001, Israel
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Tel Aviv, 6423906, Israel
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Chieti, CH, 66100, Italy
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Catania, CT, 95124, Italy
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Milan, MI, 20100, Italy
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Milan, MI, 20132, Italy
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Padua, PD, 35128, Italy
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Roma, RM, 00144, Italy
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Nagoya, Aichi-ken, 455-8530, Japan
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Nagoya, Aichi-ken, 457-8511, Japan
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Nagoya, Aichi-ken, 462-0825, Japan
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Nagoya, Aichi-ken, 466 8560, Japan
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Kurume, Fukuoka, 830-8543, Japan
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Amagasaki, Hyōgo, 660 8550, Japan
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Tsuchiura, Ibaragi, 300-0817, Japan
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Ishioka, Ibaraki, 315-0037, Japan
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Kagoshima, Kagoshima-ken, 890 8520, Japan
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Matsumoto, Nagano, 390-8621, Japan
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Saitama-shi, Saitama, 336-0963, 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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Shinjuku Ku, Tokyo, 162 8666, Japan
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Taito-ku, Tokyo, 111-0051, Japan
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Kumamoto, Japan
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Osaka, 543-0027, Japan
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Amsterdam, 1105 AZ, Netherlands
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Rotterdam, 3011 BH, Netherlands
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Tilburg, 5022 GC, Netherlands
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Coimbra, 3000-548, Portugal
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Coimbra, 3030-363, Portugal
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Leiria, 2410-187, Portugal
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Porto, 4099-001, Portugal
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Porto, 4200 319, Portugal
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Santa Maria da Feira, 4520 211, Portugal
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Vila Franca de Xira, 2600-009, Portugal
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Arecibo, 00612, Puerto Rico
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Valladolid, Castille and León, 47011, Spain
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Barcelona, Catalonia, 08036, Spain
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Sant Cugat del Vallès, Catalonia, 08190, Spain
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Valencia, Valencia, 46014, Spain
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Barcelona, 08025, Spain
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Zaragoza, 50009, Spain
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Frimley, Surrey, GU16 7UJ, United Kingdom
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Birmingham, B18 7QH, United Kingdom
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Hull, HU3 2JZ, United Kingdom
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London, NW10 7NS, United Kingdom
Novartis Investigative Site
Nottingham, NG7 2UH, United Kingdom
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2018
First Posted
March 29, 2018
Study Start
July 23, 2018
Primary Completion
November 11, 2020
Study Completion
October 18, 2021
Last Updated
January 30, 2023
Results First Posted
October 28, 2022
Record last verified: 2023-01
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.