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Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration

NCT ID: NCT04047472

Last Updated: 2024-12-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

397 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-29

Study Completion Date

2024-02-28

Brief Summary

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To compare brolucizumab to aflibercept in Chinese patients with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)

Detailed Description

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This was a randomized, double-masked, multicenter, parallel-group, active-controlled study. The study included 14 scheduled visits over 48 weeks. After confirmation of eligibility at baseline, participants were randomized in a 1:1 ratio to one of the 2 treatment arms:

* Brolucizumab 6 mg: 3 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: 3 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. Disease activity assessments (DAAs) were conducted by the masked investigator for both treatment arms at Weeks 16, 20, 32 and 44 to determine the regimen of brolucizumab arm (i.e., q12w or q8w).

Conditions

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Neovascular Age-Related Macular Degeneration

Keywords

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Macular degeneration age-related macular degeneration (AMD) vision loss macula damage retina damage wet macular degeneration AMD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Brolucizumab 6 mg

3 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.

Group Type EXPERIMENTAL

Brolucizumab 6mg

Intervention Type DRUG

Intravitreal injection

Aflibercept 2 mg

3 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.

Group Type ACTIVE_COMPARATOR

Aflibercept 2 mg

Intervention Type DRUG

Intravitreal injection

Interventions

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Brolucizumab 6mg

Intravitreal injection

Intervention Type DRUG

Aflibercept 2 mg

Intravitreal injection

Intervention Type DRUG

Other Intervention Names

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Beovu Eylea

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Beijing, Beijing Municipality, China

Site Status

Novartis Investigative Site

Guangzhou, Guangdong, China

Site Status

Novartis Investigative Site

Guangzhou, Guangdong, China

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Novartis Investigative Site

Shantou, Guangdong, China

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Novartis Investigative Site

Harbin, Heilongjiang, China

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Novartis Investigative Site

Wuhan, Hubei, China

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Novartis Investigative Site

Wuhan, Hubei, China

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Novartis Investigative Site

Nanjing, Jiangsu, China

Site Status

Novartis Investigative Site

Nanjing, Jiangsu, China

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Novartis Investigative Site

Nantong, Jiangsu, China

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Novartis Investigative Site

Yixing, Jiangsu, China

Site Status

Novartis Investigative Site

Changchun, Jilin, China

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Novartis Investigative Site

Shenyang, Liaoning, China

Site Status

Novartis Investigative Site

Xi'an, Shaanxi, China

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Novartis Investigative Site

Jinan, Shandong, China

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Novartis Investigative Site

Taiyuan, Shanxi, China

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Novartis Investigative Site

Tianjin, Tianjin Municipality, China

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Novartis Investigative Site

Hangzhou, Zhejiang, China

Site Status

Novartis Investigative Site

Hangzhou, Zhejiang, China

Site Status

Novartis Investigative Site

Beijing, , China

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Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Beijing, , China

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Novartis Investigative Site

Chongqing, , China

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Novartis Investigative Site

Chongqing, , China

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Novartis Investigative Site

Jinan, , China

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Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CRTH258A2307

Identifier Type: -

Identifier Source: org_study_id