Efficacy and Safety of RTH258 Versus Aflibercept - Study 2

Sponsor
Alcon Research
Study ID
NCT02434328
Phase
PHASE3
Status
Completed

Conditions

  • Choroidal Neovascularization
  • Neovascular Age-Related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Brolucizumab ophthalmic solution — DRUG
    Ophthalmic solution for IVT injection administered as a 6 mg/50 µL dose
  • Aflibercept ophthalmic solution — DRUG
    Ophthalmic solution for IVT injection administered as a 2 mg/50 µL dose

Study Details

The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection (6 mg) to aflibercept ophthalmic solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.

Key Dates

Start date
Jul 28, 2015
Status verified
Jan 2025
Primary completion
Apr 5, 2017
Completion
Mar 8, 2018

Study Design

Enrollment
1,048 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brolucizumab 6 mg
    Single intravitreal (IVT) injection of brolucizumab at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
  • Active Comparator: Aflibercept 2 mg
    Single IVT injection of aflibercept ophthalmic solution at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit

Primary Outcome Measure

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

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