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

ClinicalTrials.gov Identifier: NCT04047472

Novartis Reference Number: CRTH258A2307

Last Update: Dec 16, 2021

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Neovascular Age-Related Macular Degeneration
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Nov 29, 2019
Completion date 
Apr 22, 2024
Gender 
All
Age(s)
50 Years and older (Adult, Older Adult)

Interventions

Drug
Brolucizumab 6mg
Subjects will receive Brolucizumab 3 x q4w up to Week 8 followed by q12w / q8w up to Week 40 or Week 44, depending on disease activity status.
Drug
Aflibercept 2 mg
Subjects will receive Aflibercept 3 x q4w up to Week 8 followed by q8w up to Week 40.
Drug
Brolucizumab 6mg
Subjects will receive Brolucizumab 3 x q4w up to Week 8 followed by q12w / q8w up to Week 40 or Week 44, depending on disease activity status.
Drug
Aflibercept 2 mg
Subjects will receive Aflibercept 3 x q4w up to Week 8 followed by q8w up to Week 40.

Eligibility Criteria

Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.
Active choroidal neovascularization (CNV) lesions secondary to AMD that affect the central subfield in the study eye
Total area of CNV>50% of the total lesion area in the study eye at screening

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
Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) >25 mmHg
Previous treatment with any anti-VEGF drugs in the study eye.
Previous treatment with any approved or investigational drugs for neovascular AMD in the study eye.

Other protocol-specified inclusion or exclusion criteria may apply.

Study Locations

China
Novartis Investigative Site
Recruiting
Guangzhou, 410015
Guangdong
China
Novartis Investigative Site
Recruiting
Guangzhou, 510060
Guangdong
China
Novartis Investigative Site
Recruiting
Shantou, 515041
Guangdong
China
Novartis Investigative Site
Recruiting
Harbin, 150001
Heilongjiang
China
Novartis Investigative Site
Recruiting
Wuhan, 430060
Hubei
China
Novartis Investigative Site
Recruiting
Wuhan, 430070
Hubei
China
Novartis Investigative Site
Recruiting
Nanjing City, 210000
Jiangsu
China
Novartis Investigative Site
Recruiting
Nantong, 226000
Jiangsu
China
Novartis Investigative Site
Recruiting
Changchun City, 130041
Jilin
China
Novartis Investigative Site
Recruiting
Shenyang City, 110000
Liaoning
China
Novartis Investigative Site
Recruiting
Xian, 710004
Shaanxi
China
Novartis Investigative Site
Recruiting
Tianjin, 300020
Tianjin
China
Novartis Investigative Site
Recruiting
Tianjin, 300070
Tianjin
China
Novartis Investigative Site
Recruiting
Hangzhou, 310003
Zhejiang
China
Novartis Investigative Site
Recruiting
Hangzhou, 310014
Zhejiang
China
Novartis Investigative Site
Recruiting
Beijing, 100034
-
China
Novartis Investigative Site
Recruiting
Beijing, 100044
-
China
Novartis Investigative Site
Recruiting
Beijing, 100050
-
China
Novartis Investigative Site
Recruiting
Beijing, 100191
-
China
Novartis Investigative Site
Recruiting
Beijing, 100730
-
China
Novartis Investigative Site
Recruiting
Chongqing, 400038
-
China
Novartis Investigative Site
Recruiting
Chongqing, 400042
-
China
Novartis Investigative Site
Recruiting
Nanjing, 210036
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200031
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200080
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200092
-
China
Novartis Investigative Site
Recruiting
Shanghai,
-
China
Novartis Investigative Site
Recruiting
Guangzhou, 410015
Guangdong
China
Novartis Investigative Site
Recruiting
Guangzhou, 510060
Guangdong
China
Novartis Investigative Site
Recruiting
Shantou, 515041
Guangdong
China
Novartis Investigative Site
Recruiting
Harbin, 150001
Heilongjiang
China
Novartis Investigative Site
Recruiting
Wuhan, 430060
Hubei
China
Novartis Investigative Site
Recruiting
Wuhan, 430070
Hubei
China
Novartis Investigative Site
Recruiting
Nanjing City, 210000
Jiangsu
China
Novartis Investigative Site
Recruiting
Nantong, 226000
Jiangsu
China
Novartis Investigative Site
Recruiting
Changchun City, 130041
Jilin
China
Novartis Investigative Site
Recruiting
Shenyang City, 110000
Liaoning
China
Novartis Investigative Site
Recruiting
Xian, 710004
Shaanxi
China
Novartis Investigative Site
Recruiting
Tianjin, 300020
Tianjin
China
Novartis Investigative Site
Recruiting
Tianjin, 300070
Tianjin
China
Novartis Investigative Site
Recruiting
Hangzhou, 310003
Zhejiang
China
Novartis Investigative Site
Recruiting
Hangzhou, 310014
Zhejiang
China
Novartis Investigative Site
Recruiting
Beijing, 100034
-
China
Novartis Investigative Site
Recruiting
Beijing, 100044
-
China
Novartis Investigative Site
Recruiting
Beijing, 100050
-
China
Novartis Investigative Site
Recruiting
Beijing, 100191
-
China
Novartis Investigative Site
Recruiting
Beijing, 100730
-
China
Novartis Investigative Site
Recruiting
Chongqing, 400038
-
China
Novartis Investigative Site
Recruiting
Chongqing, 400042
-
China
Novartis Investigative Site
Recruiting
Nanjing, 210036
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200031
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200080
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200092
-
China
Novartis Investigative Site
Recruiting
Shanghai,
-
China

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]