Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration

Sponsor
Bioeq GmbH
Study ID
NCT02611778
Phase
PHASE3
Status
Completed

Conditions

  • Age-related Macular Degeneration (AMD)

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to determine the efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration.

Key Dates

First listed
Nov 23, 2015
Start date
Dec 19, 2015
Status verified
Sep 2021
Primary completion
Dec 31, 2017
Completion
Jun 6, 2018

Study Design

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

Arms

  • Experimental: FYB201
    FYB201 is provided as single use vials and will be administered by intra-vitreal injection.
  • Active Comparator: Lucentis
    Lucentis® is provided as single use vials and will be administered by intra-vitreal injection.

Primary Outcome Measure

Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 8 Weeks [ Time Frame: Baseline and Week 8 ]

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