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

Summary

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

Timeline

Start

2019-08-23

Primary completion

2023-01-31

Completion

2023-01-31

Outcome

Missed primary endpoint

registry analysis (superiority test); Brolucizumab 6 mg vs Aflibercept 2 mg; p = 0.013; LS mean difference -1.3 (95% CI -3.7 to 1.1); ANOVA NCT04058067 ↗

registry analysis (superiority test); Brolucizumab 6 mg vs Aflibercept 2 mg; p = 0.035; LS mean difference -1.9 (95% CI -4.2 to 0.4); ANOVA NCT04058067 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Aflibercept	Protein / enzyme biologic	2 mg	—
Subject	Brolucizumab	Other / unclassified	6 mg	—

Indications