Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Chinese Patients With Neovascular Age-Related Macular Degeneration

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04047472
Phase
PHASE3
Status
Completed

Conditions

  • Neovascular Age-Related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Brolucizumab 6mg — DRUG
    Intravitreal injection
  • Aflibercept 2 mg — DRUG
    Intravitreal injection

Study Details

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

Key Dates

Start date
Nov 29, 2019
Status verified
Oct 2024
Primary completion
Feb 28, 2024
Completion
Feb 28, 2024

Study Design

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

Arms

  • Experimental: Brolucizumab 6 mg
    3 monthly intravitreal injections of brolucizumab 6 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 12 weeks (q12w regimen) or 8 weeks (q8w) up to Week 40 or Week 44, depending on disease activity status.
  • Active Comparator: Aflibercept 2 mg
    3 monthly intravitreal injections of aflibercept 2 mg in the loading treatment period (q4w regimen) up to Week 8 followed by injections every 8 weeks (q8w) up to Week 40.

Primary Outcome Measure

Change From Baseline at Week 48 in Best-Corrected Visual Acuity in Study Eye [ Time Frame: Baseline, Week 48 ]

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