Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration
A Twelve-Month, Randomized, Double-Masked, Multicenter, Phase III, Two-Arm Study Comparing the Efficacy and Safety of Brolucizumab 6 mg Versus Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration
1 other identifier
interventional
397
1 country
30
Brief Summary
To compare brolucizumab to aflibercept in Chinese patients with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2019
Typical duration for phase_3
30 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
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
August 6, 2019
CompletedStudy Start
First participant enrolled
November 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedResults Posted
Study results publicly available
December 9, 2024
CompletedDecember 9, 2024
October 1, 2024
4.3 years
July 1, 2019
October 18, 2024
October 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline at Week 48 in Best-Corrected Visual Acuity in 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 between 78 and 23 ETDRS letters (inclusive) at Screening and 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 48
Secondary Outcomes (50)
Average Change From Baseline Over the Period of Week 36 to Week 48 in Best-Corrected Visual Acuity in Study Eye
Baseline, over the period Week 36 to Week 48
q12w Treatment Status at Week 48 (for Subjects Randomized to Brolucizumab 6 mg Only) - Probability
Week 44
q12w Treatment Status at Week 48 Within the Subjects With no q8w Need During the First q12w Cycle (Week 16 and Week 20) (for Subjects Randomized to Brolucizumab 6 mg Only) - Probability
Week 44
Number (%) of Participants With q8w Treatment Need as Assessed by the Investigator at First Disease Activity Assessment (DAA) Visit
Week 16
Change From Baseline at Each Study Visit in Best-Corrected Visual Acuity in Study Eye
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44
- +45 more secondary outcomes
Study Arms (2)
Brolucizumab 6 mg
EXPERIMENTAL3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.
Aflibercept 2 mg
ACTIVE COMPARATOR3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent must be obtained before any assessment was performed.
- Male or female Chinese participants ≥ 50 years of age at the time of screening.
- Active CNV lesions secondary to AMD that affect the central subfield (including retinal angiomatous proliferation lesions with a CNV component) in the study eye at screening and confirmed by the Central Reading Center (CRC).
- Total area of CNV (including both classic and occult components) must comprise \> 50% of the total lesion area in the study eye at screening and confirmed by the CRC.
- Intra and/or subretinal fluid affecting the central subfield of the study eye at screening and confirmed by the CRC.
- BCVA between 78 and 23 letters, inclusive, in the study eye at screening and baseline using ETDRS testing.
You may not qualify if:
- Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at baseline.
- Central subfield of the study eye affected by fibrosis or geographic atrophy assessed by color fundus photography at screening and confirmed by the CRC.
- Total area of fibrosis ≥ 50% of the total lesion in the study eye at screening and confirmed by the CRC.
- Subretinal blood affecting the foveal center point and/or ≥ 50% of the lesion of the study eye at screening and confirmed by the CRC.
- Previous treatment with any approved or investigational drugs for nAMD in the study eye (other than vitamin supplements).
- Retinal pigment epithelium rip/tear in the study eye at screening.
- Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to baseline.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Novartis Investigative Site
Beijing, Beijing Municipality, 100044, China
Novartis Investigative Site
Guangzhou, Guangdong, 410015, China
Novartis Investigative Site
Guangzhou, Guangdong, 510060, China
Novartis Investigative Site
Shantou, Guangdong, 515041, China
Novartis Investigative Site
Harbin, Heilongjiang, 150001, China
Novartis Investigative Site
Wuhan, Hubei, 430060, China
Novartis Investigative Site
Wuhan, Hubei, 430070, China
Novartis Investigative Site
Nanjing, Jiangsu, 210000, China
Novartis Investigative Site
Nanjing, Jiangsu, 210029, China
Novartis Investigative Site
Nantong, Jiangsu, 226000, China
Novartis Investigative Site
Yixing, Jiangsu, 214299, China
Novartis Investigative Site
Changchun, Jilin, 130041, China
Novartis Investigative Site
Shenyang, Liaoning, 110000, China
Novartis Investigative Site
Xi'an, Shaanxi, 710004, China
Novartis Investigative Site
Jinan, Shandong, 250004, China
Novartis Investigative Site
Taiyuan, Shanxi, 030002, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300020, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310003, China
Novartis Investigative Site
Hangzhou, Zhejiang, 310014, China
Novartis Investigative Site
Beijing, 100034, China
Novartis Investigative Site
Beijing, 100050, China
Novartis Investigative Site
Beijing, 100191, China
Novartis Investigative Site
Beijing, 100730, China
Novartis Investigative Site
Chongqing, 400038, China
Novartis Investigative Site
Chongqing, 400042, China
Novartis Investigative Site
Jinan, 250012, China
Novartis Investigative Site
Shanghai, 200001, China
Novartis Investigative Site
Shanghai, 200031, China
Novartis Investigative Site
Shanghai, 200080, China
Novartis Investigative Site
Shanghai, 200092, China
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
July 1, 2019
First Posted
August 6, 2019
Study Start
November 29, 2019
Primary Completion
February 28, 2024
Study Completion
February 28, 2024
Last Updated
December 9, 2024
Results First Posted
December 9, 2024
Record last verified: 2024-10
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