Efficacy and Safety of RTH258 Versus Aflibercept - Study 1

Part of paid clinical trials in Fort Worth, Texas.

Sponsor
Alcon Research
Study ID
NCT02307682
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
  • Aflibercept ophthalmic solution — DRUG
    Ophthalmic solution for IVT injection

Study Details

The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection at two dosage levels (3 mg and 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
Dec 8, 2014
Status verified
Jan 2025
Primary completion
Apr 22, 2017
Completion
Mar 28, 2018

Study Design

Enrollment
1,775 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brolucizumab 3 mg
    Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose 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
  • Experimental: Brolucizumab 6 mg
    Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
  • Active Comparator: Aflibercept 2 mg
    Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose 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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Contact Alcon Call Center for Trial LocationsFort WorthTexas76134-

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