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

NCT04522167 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 434

Last updated 2025-11-13

Study results available
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Summary

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.

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

DRUG

FYB203 (Proposed aflibercept biosimilar)

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.

DRUG

Eylea® (Aflibercept)

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.

Sponsors & Collaborators

  • Bioeq GmbH

    lead INDUSTRY

Principal Investigators

  • Study Official · Bioeq GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-21
Primary Completion
2022-06-23
Completion
2023-05-18
FDA Drug
Yes

Countries

  • Bulgaria
  • Czechia
  • Hungary
  • Israel
  • Italy
  • Japan
  • Poland
  • Russia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04522167 on ClinicalTrials.gov