A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03481660
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Brolucizumab — DRUG
    Intravitreal injection
  • Aflibercept — DRUG
    Intravitreal injection

Study Details

This was a Phase III, randomized, double-masked, multi-center, active-controlled, two-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg compared to the active control, aflibercept 2 mg used per authorized label, in subjects with visual impairment due to diabetic macular edema (DME).

Key Dates

Start date
Jul 27, 2018
Status verified
Jan 2025
Primary completion
Jun 29, 2020
Completion
Jun 8, 2021

Study Design

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

Arms

  • Experimental: Brolucizumab 6 mg
    Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule
  • Active Comparator: Aflibercept 2 mg
    Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks

Primary Outcome Measure

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

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