To Compare Brolucizumab to Aflibercept in Chinese Patients With Visual Impairment Due to Diabetic Macular Edema

A One-Year, Randomized, Double-Masked, Multicenter, Phase III, Two-Arm Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Chinese Patients With Visual Impairment Due to Diabetic Macular Edema

ClinicalTrials.gov Identifier: NCT04058067

Novartis Reference Number: CRTH258B2304

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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

The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of Chinese patients with visual impairment due to Diabetic Macular Edema.

Condition 
Diabetic Macular Edema
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
268 participants
Start date 
Aug 23, 2019
Completion date 
Mar 14, 2023
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Brolucizumab
5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance
Drug
Aflibercept
5 x every 4 weeks loading then every 8 weeks maintenance

Eligibility Criteria

Inclusion Criteria:

Patients with type 1 or type 2 diabetes mellitus
Visual impairment due to Diabetic Macular Edema

Exclusion Criteria:

Any active intraocular or periocular infection or active intraocular inflammation
Structural damage of the fovea
Uncontrolled glaucoma
Neovascularization of the iris

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

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, 430070
Hubei
China
Novartis Investigative Site
Recruiting
Nanjing, 210029
Jiangsu
China
Novartis Investigative Site
Recruiting
Wuxi,
Jiangsu
China
Novartis Investigative Site
Recruiting
Chengdu, 610041
Sichuan
China
Novartis Investigative Site
Recruiting
Tianjin, 300020
Tianjin
China
Novartis Investigative Site
Recruiting
Tianjin, 300070
Tianjin
China
Novartis Investigative Site
Recruiting
Hangzhou, 310014
Zhejiang
China
Novartis Investigative Site
Recruiting
Beijing, 100034
-
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
Shanghai, 200080
-
China

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]