Neovascular Age-related Macular DegenerationPhase 3MAGELLAN-AMDNCT04522167
Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration
A Phase 3 study testing FYB203 (Proposed aflibercept biosimilar) and Eylea® (Aflibercept) in people with Neovascular Age-related Macular Degeneration, run by Bioeq GmbH at 66 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- FYB203 (Proposed aflibercept biosimilar) and Eylea® (Aflibercept)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 66 sitesin 9 countries
- Study dates
- 21 Jul 2020to 18 May 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years at Screening.
- Male or female:
- Male: A male patient must agree to use contraception as defined in this protocol during the treatment period and for at least 4 weeks after the last dose of study treatment.
- Female: A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- Not a woman of childbearing potential (WOCBP), OR
- A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.
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- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Willingness and ability to undertake all scheduled visits and assessments.
- Newly diagnosed choroidal neovascularization (CNV) lesion secondary to wet AMD
Who cannot join
- Patients are not eligible for the study if any of the following criteria apply:
- Employees of clinical study sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized.
- Study eye requiring immediate treatment.
- Any prior treatment with VEGF agent or any investigational products to treat AMD in either eye.
- Uncontrolled ocular hypertension or glaucoma in the SE (defined as intraocular pressure [IOP] ≥ 30 mmHg, despite treatment with anti-glaucomatous medication).
- Ocular disorders in the SE (i.e. retinal detachment, pre-retinal membrane of the macula or cataract with significant impact on VA) at the time of screening that may confound interpretation of study results and compromise VA.
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- Any concurrent intraocular condition in the SE (e.g. glaucoma, cataract, or diabetic retinopathy) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results.
- Use of other investigational drugs (excluding vitamins, minerals) within 30 days or 5 half lives from randomization, whichever is longer.
- Any type of advanced, severe, or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
- Stroke or myocardial infarction within 6 months prior to randomization.
- Known hypersensitivity to the IMP (aflibercept or any component of the aflibercept formulation) or to drugs of similar chemical class or to fluorescein or any other component of fluorescein formulation.
Trial locations and contacts
66 sites in 9 countries.
66 sites in 9 countries
Japan20 sites
Research Site
Akita
Research Site
Amagasaki
Research Site
Asahikawa
Research Site
Chiyoda City
Research Site
Chūō
Research Site
Fukuoka
Research Site
Fukushima
Research Site
Hamamatsu
Research Site
Himeji
Research Site
Hirakata
Research Site
Kita-ku
Research Site
Kurume
Research Site
Meguro City
Research Site
Nagasaki
Research Site
Nagoya
Research Site
Sapporo
Research Site
Shinjuku-Ku
Research Site
Suita
Research Site
Toride
Research Site
Yokosuka
Hungary7 sites
Research Site
Budapest
Research Site
Debrecen
Research Site
Pécs
Research Site
Szeged
Research Site
Székesfehérvár
Research Site
Tatabánya
Research Site
Zalaegerszeg
Israel7 sites
Research Site
Haifa
Research Site
Jerusalem
Research Site
Kfar Saba
Research Site
Petah Tikva
Research Site
Rehovot
Research Site
Rishon LeZiyyon
Research Site
Tel Aviv
Poland7 sites
Research Site
Bielsko-Biala
Research Site
Bydgoszcz
Research Site
Krakow
Research Site
Lodz
Research Site
Olsztyn
Research Site
Tarnów
Research Site
Warsaw
Ukraine7 sites
Research Site
Kharkiv
Research Site
Kherson
Research Site
Kropyvnytskyi
Research Site
Lutsk
Research Site
Odesa
Research Site
Poltava
Research Site
Zaporizhzhya
Italy6 sites
Research Site
Bologna
Research Site
Florence
Research Site
Milan
Research Site
Roma
Research Site
Rozzano
Research Site
Udine
Czechia5 sites
Research Site
Hradec Králové
Research Site
Ostrava
Research Site
Pardubice
Research Site
Prague
Research Site
Sokolov
Russia5 sites
Research Site
Chelyabinsk
Research Site
Kazan'
Research Site
Moscow
Research Site
Novosibirsk
Research Site
Saint Petersburg
About this study
Official title: A Phase 3 Randomized, Double-masked, Multicenter Study to Compare the Efficacy and Safety of the Proposed Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration
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.
- Being tested
- FYB203 (Proposed aflibercept biosimilar), Eylea® (Aflibercept)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| FYB203 (Proposed aflibercept biosimilar) | Experimental | Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol. Receives: Drug: FYB203 (Proposed aflibercept biosimilar) |
| Eylea® (Aflibercept) | Active comparator | Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol. Receives: Drug: Eylea® (Aflibercept) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Changes in Best Corrected Visual Acuity (BCVA) by ETDRS letters from the Baseline Visit (Visit 1) to Week 8 (Visit 3) were assessed. This involved measuring the number of letters a participant could correctly read using the study eye on the ETDRS chart. An increase in the number of ETDRS letters from baseline signifies an improvement in visual acuity of the study eye. The change from baseline was calculated as the observed post-baseline value minus the baseline value.
Measured: Week 8
Secondary outcomes (8)
Evaluate and Compare Functional Changes of the Retina by BCVA Over Time
Change of BCVA by ETDRS letters over the whole study from Baseline Visit (Visit 1) to Week 24 (Visit 5) and Week 56 (Visit 9) - FAS
Measured: Through study completion, until Week 56 (Visit 9)
Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness
Change from Baseline Visit (Visit 1) in foveal center point FCP retinal thickness to Week 4 (Visit 2), Week 24 (Visit 5) and Week 56 (Visit 9) - FAS
Measured: Through study completion, until Week 56 (Visit 9)
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
Proportion of patients who gain or lose ≥ 5, 10, or 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters from Baseline Visit (Visit 1) to Week 24 (Visit 5) and Week 56 (Visit 9) - FAS
Measured: Through study completion, until Week 56 (Week 9)
Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time
Percentage of patients with fluid-free macula at Baseline (Visit 1), Week 24 (Visit 5), Week 56 (Visit 9) - FAS
Measured: Through study completion, until Week 56 (Visit 9)
Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm)
Systemic concentrations (close to maximum concentration [Cmax]) of free aflibercept in a subgroup at selected sites - PKS:
- 48 hours after the 3rd dose (Visit 3a)
Measured: At Baseline and Visit 3a (48 hours after the 3rd dose)
Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)
Change from Baseline Visit (Visit 1) in vision-related functioning and well-being measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) to Week 24 (Visit 5) and Week 56 (Visit 9) - FAS. The NEI VFQ-25 includes 12 subscales (e.g., general vision, ocular pain, driving, peripheral vision) scored from 0 to 100, where higher scores indicate better functioning. Subscales are averaged to produce a composite score, excluding the general health subscale. Both subscale and composite scores range from 0 (worst) to 100 (best), representing the percentage of the highest possible score achieved.
Measured: Through study completion, until Week 56 (Visit 9)
Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum
Number of patients with anti-drug antibodies (ADAs) at Baseline (Visit 1), Week 24 (Visit 5) and Week 56 (Visit 9) - SAF
Measured: Through study completion, until Week 56 (Visit 9)
Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs)
Frequency of local and systemic adverse events (AEs) and serious adverse events (SAEs) - SAF
Measured: Through study completion, until Week 56 (Visit 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start21 Jul 2020
- Primary completion23 Jun 2022
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioeq GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Official, Study director, Bioeq GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522167
- Sponsor's protocol ID
- FYB203-03-01
- Acronym
- MAGELLAN-AMD
- Status last verified
- Oct 2024
- First submitted
- 11 Aug 2020
- Last updated
- 13 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balser S, Capsius B, Hole R, Papp A, Preissinger N, Rozenknop A, Tiko T. Randomised, double-masked trial to compare the efficacy, safety and immunogenicity of the biosimilar aflibercept FYB203 with reference aflibercept in patients with neovascular age-related macular degeneration. BMJ Open Ophthalmol. 2026 Jan 5;11(1):e002398. doi: 10.1136/bmjophth-2025-002398.
PubMed 41494750
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-masked, Multicenter Study to Compare the Efficacy and Safety of the Proposed Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT04522167
- Acronym / sponsor ID
- MAGELLAN-AMD / FYB203-03-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Bioeq GmbHIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Posted 13 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FYB203 (Proposed aflibercept biosimilar) | Experimental | Drug: FYB203 (Proposed aflibercept biosimilar)Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol. |
| Eylea® (Aflibercept) | Active comparator | Drug: Eylea® (Aflibercept)Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 50 years at Screening.
- Male or female:
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Willingness and ability to undertake all scheduled visits and assessments.
- Newly diagnosed choroidal neovascularization (CNV) lesion secondary to wet AMD
Key exclusion criteria (11 listed)
- Employees of clinical study sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized.
- Study eye requiring immediate treatment.
- Any prior treatment with VEGF agent or any investigational products to treat AMD in either eye.
- Uncontrolled ocular hypertension or glaucoma in the SE (defined as intraocular pressure [IOP] ≥ 30 mmHg, despite treatment with anti-glaucomatous medication).
- Ocular disorders in the SE (i.e. retinal detachment, pre-retinal membrane of the macula or cataract with significant impact on VA) at the time of screening that may confound interpretation of study results and compromise VA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | FYB203 (Proposed aflibercept biosimilar) |
| 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. | Drug | Eylea® (Aflibercept) |
Primary outcome
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
Changes in Best Corrected Visual Acuity (BCVA) by ETDRS letters from the Baseline Visit (Visit 1) to Week 8 (Visit 3) were assessed. This involved measuring the number of letters a participant could correctly read using the study eye on the ETDRS chart. An increase in the number of ETDRS letters from baseline signifies an improvement in visual acuity of the study eye. The change from baseline was calculated as the observed post-baseline value minus the baseline value.
8 secondary outcomes
Evaluate and Compare Functional Changes of the Retina by BCVA Over Time
Time frame: Through study completion, until Week 56 (Visit 9)
Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness
Time frame: Through study completion, until Week 56 (Visit 9)
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
Time frame: Through study completion, until Week 56 (Week 9)
Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time
Time frame: Through study completion, until Week 56 (Visit 9)
Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm)
Time frame: At Baseline and Visit 3a (48 hours after the 3rd dose)
Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)
Time frame: Through study completion, until Week 56 (Visit 9)
Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum
Time frame: Through study completion, until Week 56 (Visit 9)
Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Through study completion, until Week 56 (Visit 9)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41494750Balser S, Capsius B, Hole R, Papp A, Preissinger N, Rozenknop A, Tiko T. Randomised, double-masked trial to compare the efficacy, safety and immunogenicity of the biosimilar aflibercept FYB203 with reference aflibercept in patients with neovascular age-related macular degeneration. BMJ Open Ophthalmol. 2026 Jan 5;11(1):e002398. doi: 10.1136/bmjophth-2025-002398.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Official study director
Bioeq GmbH
66 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FYB203 (Proposed aflibercept biosimilar) and Eylea® (Aflibercept) in people with Neovascular Age-related Macular Degeneration, run by Bioeq GmbH at 66 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in Japan, Hungary, Israel, Poland, Ukraine and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04522167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.