Clinical trial registry record

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

A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.

Plain-language guide

Five questions to ask about this record

What this is
A clinical study registration, not a result or recommendation.
Why it may matter
The registry currently reports Completed.
Evidence
Registered phase 3 study.
Main limitation
Registration does not prove that the intervention works, is safe, or is available to you.
What changed
Registry metadata was last updated November 13, 2025.
Where to verify
Open the primary registry below for eligibility, locations, contacts, and current status.
Registry ID
NCT04522167
Last registry update
November 13, 2025
Status
Completed
Phase
Phase 3
Sponsor
Bioeq GmbH
Enrollment
434
Countries
Bulgaria, Czechia, Hungary, Israel, Italy, Japan, Poland, Russia, Ukraine
Match confidence
100%
Source feed
ClinicalTrials.gov
Automated source synopsis

A registered PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.

Evidence snapshot

What the source actually supports

Evidence stage
Phase 3
Study design
RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE
Evidence population
Human clinical study registration
Participants
434
Population
ALL · 50 Years
Duration
2020-07-21 to 2023-05-18
Intervention
FYB203 (Proposed aflibercept biosimilar); Eylea® (Aflibercept)
Comparator
Eylea® (Aflibercept)
Outcomes measured
Evaluate and Compare Functional Changes in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy…; Evaluate and Compare Functional Changes of the Retina by BCVA Over Time — Through study completion, until Week 56 (Visi…; Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness — Through study completion, until Week 56 (…; Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy S…; Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time — Through study completion, until We…; Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm) — A…; Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Func…; Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum — Through study completion, until W…; Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) — Through study completion, unti…
Reported result
No reusable finding-level result is available in this record.

Main limitationThis is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.

Safety and approvalEligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians. Trial registration is not regulatory approval and does not establish that an intervention is available.

Source supportStructured registry protocol metadata; no finding-level conclusion is generated.

Trial stage · Phase 3A trial phase describes development stage; it does not establish a positive result.
Phase 1Phase 2Phase 3Phase 4

Registration and recruitment status do not establish safety, efficacy, or regulatory approval.

Why this record appears here · 100% topic match

The title, summary, or source keywords matched one or more topics followed by immortal.life. A higher percentage means a stronger topic match; it does not rate safety, effectiveness, or study quality.

  • Vision ageing · 100%Title contains controlled term: age-related macular degeneration. Source terminology contains: age-related macular degeneration. Title supplies longevity context: age-related. Study type is explicitly identified as INTERVENTIONAL.

Automated source check 100% · update recency 85%. These figures help sort records; they are not medical ratings.