Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration

Sponsor
Bioeq GmbH
Study ID
NCT04522167
Phase
PHASE3
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • FYB203 (Proposed aflibercept biosimilar) — DRUG
    Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
  • Eylea® (Aflibercept) — DRUG
    Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.

Study Details

This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.

Key Dates

Start date
Jul 21, 2020
Status verified
Oct 2024
Primary completion
Jun 23, 2022
Completion
May 18, 2023

Study Design

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

Arms

  • Experimental: FYB203 (Proposed aflibercept biosimilar)
    Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
  • Active Comparator: Eylea® (Aflibercept)
    Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.

Primary Outcome Measure

Evaluate and Compare Functional Changes in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at Week 8 of Treatment With FYB203 or Eylea Compared to Baseline. [ Time Frame: Week 8 ]

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