NCT04058067

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is a randomized, double-masked, multi-center, active-controlled, 2-arm study in Chinese patients with Diabetic macular edema (DME). Approximately 335 Chinese patients were planned to be screened (20% screening failure rate expected) and approximately 268 (134 per arm) patients were planned to be randomized in approximately 25 centers. Patients who met all the inclusion and none of the exclusion criteria were randomized in a 1:1 ratio to one of two treatment arms: * Brolucizumab 6 mg: 5 × every 6 weeks (q6w) loading then every 12 weeks (q12w) or every 8 weeks (q8w) maintenance * Aflibercept 2 mg: 5 × every 4 weeks (q4w) loading then q8w maintenance Disease activity assessments (DAAs) were conducted by the masked investigator for both treatment arms at Weeks 32, 36, and 48. In the brolucizumab arm, subjects who qualified for q12w during this initial q12w interval continued on a q12w treatment frequency unless disease activity was identified at the subsequent DAA visit at Week 48, in which case subjects were switched to a q8w treatment interval until Week 52.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-08-23
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2019-08-15
• Last updated: 2024-10-09
• Results posted: 2024-09-19

Locations

24 sites across 1 country: China