Clinical trial registry record

Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis 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 September 30, 2021.
Where to verify
Open the primary registry below for eligibility, locations, contacts, and current status.
Registry ID
NCT02611778
Last registry update
September 30, 2021
Status
Completed
Phase
Phase 3
Sponsor
Bioeq GmbH
Enrollment
712
Countries
Austria, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Russia, Spain, Ukraine, United Kingdom
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
712
Population
ALL · 50 Years
Duration
2015-12-19 to 2018-06-06
Intervention
ranibizumab
Comparator
Lucentis
Outcomes measured
Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 8 Weeks — Baseline and Week 8; Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 24 Weeks — Baseline and Week 24; Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 48 Weeks — Baseline and Week 48; Change From Baseline in Best Corrected Visual Acuity (BCVA) [Letters] After 12 Months — Baseline and 12 Months; Change in Foveal Centre Point (FCP) Retinal Thickness From Baseline to Week 24 — Baseline and Week 24; Change in Foveal Centre Point (FCP) Retinal Thickness From Baseline to Week 48 — Baseline and Week 48; Change in Foveal Central Subfield (FCS) Retinal Thickness From Baseline to Week 24 — Baseline and Week 24; Change in Foveal Central Subfield (FCS) Retinal Thickness From Baseline to Week 48 — Baseline and Week 48; Change in Total Lesion Area From Baseline to Week 24 — Baseline and Week 24; Change in Total Lesion Area From Baseline to Week 48 — Baseline and Week 48; Change in NEI VFQ-25 Composite Score From Baseline to Week 24 — Baseline and Week 24; Change in NEI VFQ-25 Composite Score From Baseline to Week 48 — Baseline and Week 48; Active CNV Leakage at Week 24 — Baseline and Week 24; Active CNV Leakage at Week 48 — Baseline and Week 48; Fluid-free Macula at Each Visit — Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; Anti-drug Antibodies by Scheduled eCRF Visit — Baseline and Weeks 1, 4, 12, 24, 48; Anti-drug Antibodies Pre- and Post-first Dosing — Baseline and up to Week 48
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 topic terminology. Summary contains controlled topic terminology. Source terminology contains a controlled topic term. Title supplies ageing or longevity context.

Automated source check 100% · update recency 50%. These figures help sort records; they are not medical ratings.