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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04058067
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brolucizumab — DRUG
    5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance
  • Aflibercept — DRUG
    5 x every 4 weeks loading then every 8 weeks maintenance

Study Details

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.

Key Dates

Start date
Aug 23, 2019
Status verified
Oct 2024
Primary completion
Jan 31, 2023
Completion
Jan 31, 2023

Study Design

Enrollment
266 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brolucizumab 6 mg
    5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance
  • Active Comparator: Aflibercept 2 mg
    5 x every 4 weeks loading then every 8 weeks maintenance

Primary Outcome Measure

Change From Baseline at Week 52 in Best-corrected Visual Acuity (BCVA) for the Study Eye. [ Time Frame: Baseline to Week 52 ]

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