Efficacy and Safety of the Aflibercept FYB203 Biosimilar... | NCT04522167 | Trialant
NCT04522167
Sponsor
Bioeq GmbH
Status
Completed
Last Update Posted
Nov 13, 2025Actual
Enrollment
434Actual
Phase
Phase 3
Conditions
Neovascular Age-related Macular Degeneration
Interventions
FYB203 (Proposed aflibercept biosimilar)
Eylea® (Aflibercept)
Countries
Bulgaria
Czechia
Hungary
Israel
Italy
Japan
Poland
Russia
Ukraine
Protocol Section
Identification Module
NCT ID
NCT04522167
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
FYB203-03-01
Secondary IDs
Not provided
Brief Title
Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration
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
Acronym
MAGELLAN-AMD
Organization
Bioeq GmbHINDUSTRY
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 21, 2020Actual
Primary Completion Date
Jun 23, 2022Actual
Completion Date
May 18, 2023Actual
First Submitted Date
Aug 11, 2020
First Submission Date that Met QC Criteria
Aug 19, 2020
First Posted Date
Aug 21, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Aug 8, 2024
Results First Submitted that Met QC Criteria
Oct 31, 2025
Results First Posted Date
Nov 13, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 31, 2025
Last Update Posted Date
Nov 13, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bioeq GmbHINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief 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.
Detailed Description
Not provided
Conditions Module
Conditions
Neovascular Age-related Macular Degeneration
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
434Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
FYB203 (Proposed aflibercept biosimilar)
Experimental
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
Drug: FYB203 (Proposed aflibercept biosimilar)
Eylea® (Aflibercept)
Active Comparator
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Drug: Eylea® (Aflibercept)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
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.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Week 8
Secondary Outcomes
Measure
Description
Time Frame
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
Through study completion, until Week 56 (Visit 9)
Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
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.
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
Exclusion Criteria:
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.
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.
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Only 1 eye was selected from each patient as the study eye. Patients with signs of nAMD in the fellow eye likely to require IVT anti-VEGF treatment during the study were excluded. Any necessary treatment for wAMD in the fellow eye was prohibited for the first eight weeks and could only occur with Eylea at least 14 days after study eye treatment, without classifying the fellow eye as a study eye.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
FYB203 (Proposed Aflibercept Biosimilar)
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
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.
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.
Eylea® (Aflibercept)
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
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
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
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)
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.
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
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
Through study completion, until Week 56 (Visit 9)
Stara Zagora
Bulgaria
Research Site
Hradec Králové
Czechia
Research Site
Ostrava
Czechia
Research Site
Pardubice
Czechia
Research Site
Prague
Czechia
Research Site
Sokolov
Czechia
Research Site
Budapest
Hungary
Research Site
Debrecen
Hungary
Research Site
Pécs
Hungary
Research Site
Szeged
Hungary
Research Site
Székesfehérvár
Hungary
Research Site
Tatabánya
Hungary
Research Site
Zalaegerszeg
Hungary
Research Site
Haifa
Israel
Research Site
Jerusalem
Israel
Research Site
Kfar Saba
Israel
Research Site
Petah Tikva
Israel
Research Site
Rehovot
Israel
Research Site
Rishon LeZiyyon
Israel
Research Site
Tel Aviv
Israel
Research Site
Bologna
Italy
Research Site
Florence
Italy
Research Site
Milan
Italy
Research Site
Roma
Italy
Research Site
Rozzano
Italy
Research Site
Udine
Italy
Research Site
Akita
Japan
Research Site
Amagasaki
Japan
Research Site
Asahikawa
Japan
Research Site
Chiyoda City
Japan
Research Site
Chūō
Japan
Research Site
Fukuoka
Japan
Research Site
Fukushima
Japan
Research Site
Hamamatsu
Japan
Research Site
Himeji
Japan
Research Site
Hirakata
Japan
Research Site
Kita-ku
Japan
Research Site
Kurume
Japan
Research Site
Meguro City
Japan
Research Site
Nagasaki
Japan
Research Site
Nagoya
Japan
Research Site
Sapporo
Japan
Research Site
Shinjuku-Ku
Japan
Research Site
Suita
Japan
Research Site
Toride
Japan
Research Site
Yokosuka
Japan
Research Site
Bielsko-Biala
Poland
Research Site
Bydgoszcz
Poland
Research Site
Krakow
Poland
Research Site
Lodz
Poland
Research Site
Olsztyn
Poland
Research Site
Tarnów
Poland
Research Site
Warsaw
Poland
Research Site
Chelyabinsk
Russia
Research Site
Kazan'
Russia
Research Site
Moscow
Russia
Research Site
Novosibirsk
Russia
Research Site
Saint Petersburg
Russia
Research Site
Kharkiv
Ukraine
Research Site
Kherson
Ukraine
Research Site
Kropyvnytskyi
Ukraine
Research Site
Lutsk
Ukraine
Research Site
Odesa
Ukraine
Research Site
Poltava
Ukraine
Research Site
Zaporizhzhya
Ukraine
FG001
Eylea® (Aflibercept)
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
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.
FG000215 subjects
FG001219 subjects
COMPLETED
FG000196 subjects
FG001206 subjects
NOT COMPLETED
FG00019 subjects
FG00113 subjects
Safety Analysis Set (SAF)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
FYB203 (Proposed Aflibercept Biosimilar)
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
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.
BG001
Eylea® (Aflibercept)
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
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.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000215
BG001218
BG002433
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00073.7± 7.72
BG00173.3± 7.70
BG00273.5± 7.71
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Age, Categorical
Title
Measurements
Between 18 and 64 years
BG00017
BG00125
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000121
BG001127
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0015
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Bulgaria
Title
Measurements
BG00010
BG00111
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Full Analysis Set (FAS)
Posted
Least Squares Mean
Standard Error
letters
Week 8
ID
Title
Description
OG000
FYB203 (Proposed Aflibercept Biosimilar)
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
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.
OG001
Eylea® (Aflibercept)
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
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.
Units
Counts
Participants
OG000215
OG001218
Title
Denominators
Categories
Title
Measurements
OG0006.6± 0.73
OG0015.6± 0.73
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
LS mean difference
1.0
Standard Error of the Mean
0.76
2-Sided
90.4
-0.3
2.2
Equivalence
If the confidence interval for difference in LSMeans is completely contained in the interval ]-3.5 letters; 3.5 letters[, FBY203 and Eylea are considered equivalent.](streamdown:incomplete-link)
Secondary
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
FAS = Full Analysis Set
Posted
Mean
Standard Deviation
letters
Through study completion, until Week 56 (Visit 9)
ID
Title
Description
OG000
FYB203 (Proposed Aflibercept Biosimilar)
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
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.
OG001
Eylea® (Aflibercept)
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
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.
Units
Counts
Participants
Secondary
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
FAS = Full Analysis Set
Posted
Mean
Standard Deviation
μm
Through study completion, until Week 56 (Visit 9)
ID
Title
Description
OG000
FYB203 (Proposed Aflibercept Biosimilar)
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
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.
OG001
Eylea® (Aflibercept)
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
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.
Units
Counts
Participants
Secondary
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
FAS = Full Analysis Set
Posted
Count of Participants
Participants
Through study completion, until Week 56 (Week 9)
ID
Title
Description
OG000
FYB203 (Proposed Aflibercept Biosimilar)
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
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.
OG001
Eylea® (Aflibercept)
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
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.
Units
Secondary
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
FAS = Full Analysis Set
Posted
Count of Participants
Participants
Through study completion, until Week 56 (Visit 9)
ID
Title
Description
OG000
FYB203 (Proposed Aflibercept Biosimilar)
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
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.
OG001
Eylea® (Aflibercept)
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
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.
Units
Counts
Participants
Secondary
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)
PKS = Plasma Concentration Analysis Set. Baseline values that were reported as \
Posted
Mean
Standard Deviation
ng/mL
At Baseline and Visit 3a (48 hours after the 3rd dose)
ID
Title
Description
OG000
FYB203 (Proposed Aflibercept Biosimilar)
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
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.
OG001
Eylea® (Aflibercept)
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
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.
Secondary
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.
FAS = Full Analysis Set
Posted
Mean
Standard Deviation
score points
Through study completion, until Week 56 (Visit 9)
ID
Title
Description
OG000
FYB203 (Proposed Aflibercept Biosimilar)
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
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.
OG001
Eylea® (Aflibercept)
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
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.
Secondary
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
SAF = Safety Analysis Set
Posted
Count of Participants
Participants
Through study completion, until Week 56 (Visit 9)
ID
Title
Description
OG000
FYB203 (Proposed Aflibercept Biosimilar)
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
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.
OG001
Eylea® (Aflibercept)
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
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.
Units
Counts
Participants
Secondary
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
SAF = Safety Analysis Set
Posted
Count of Participants
Participants
Through study completion, until Week 56 (Visit 9)
ID
Title
Description
OG000
FYB203 (Proposed Aflibercept Biosimilar)
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
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.
OG001
Eylea® (Aflibercept)
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
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.
Units
Counts
Participants
Time Frame
All AEs reported until the final end of study visit at week 56 are included.
Description
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
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.
In this column all systemic AEs by patient for the FYB203 group are given.
4
215
17
215
56
215
EG001
Eylea® (Aflibercept), Systemic AE
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
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.
In this column all systemic AEs by patient for the Eylea® group are given.
1
218
23
218
46
218
EG002
FYB203 (Proposed Aflibercept Biosimilar), Ocular AE, Study Eye
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
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.
In this column all ocular AEs by patient for the FYB203 group occurring in the study eye are given.
0
215
2
215
44
215
EG003
Eylea® (Aflibercept), Ocular AE, Study Eye
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
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.
In this column all ocular AEs by patient for the Eylea® group occurring in the study eye are given.
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
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.
The fellow eye could be treated with Eylea®, which was allowed after Visit 3 and was to be separated by at least 14 days from study eye treatment. In this group, 19 patients choose to get treatment for the fellow eye (from 1 to 6 injections).
In this column all ocular AEs by patient for the FYB203 group occurring in the fellow eye are given.
0
215
0
215
37
215
EG005
Eylea® (Aflibercept), Ocular AE, Fellow Eye
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
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.
The fellow eye could be treated with Eylea®, which was allowed after Visit 3 and was to be separated by at least 14 days from study eye treatment. In this group, 20 patients choose to get treatment for the fellow eye (from 1 to 6 injections).
In this column all ocular AEs by patient for the Eylea® group occurring in the fellow eye are given.
0
218
3
218
32
218
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
COVID-19
Infections and infestations
MedDRA v 23.0 Mixed
Systematic Assessment
EG0004 events4 affected215 at risk
EG0011 events1 affected218 at risk
EG0020 events0 affected215 at risk
EG0030 events0 affected218 at risk
EG0040 events0 affected215 at risk
EG0050 events0 affected218 at risk
COVID-19 pneumonia
Infections and infestations
MedDRA v 23.0 Mixed
Systematic Assessment
EG0001 events1 affected215 at risk
EG0012 events2 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Appendicitis
Infections and infestations
MedDRA v 23.0 Mixed
Systematic Assessment
EG0000 events0 affected215 at risk
EG0012 events2 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v 23.0 Mixed
Systematic Assessment
EG0003 events1 affected215 at risk
EG0011 events1 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v 23.0 Mixed
Systematic Assessment
EG0001 events1 affected215 at risk
EG0010 events0 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Colonic abscess
Infections and infestations
MedDRA v 23.0 Mixed
Systematic Assessment
EG0000 events0 affected215 at risk
EG0011 events1 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Coronavirus infection
Infections and infestations
MedDRA v 23.0 Mixed
Systematic Assessment
EG0001 events1 affected215 at risk
EG0010 events0 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Gallbladder empyema
Infections and infestations
MedDRA v 23.0 Mixed
Systematic Assessment
EG0001 events1 affected215 at risk
EG0010 events0 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Peritonitis
Infections and infestations
MedDRA v 23.0 Mixed
Systematic Assessment
EG0000 events0 affected215 at risk
EG0011 events1 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Toxic shock syndrome
Infections and infestations
MedDRA v 23.0 Mixed
Systematic Assessment
EG0001 events1 affected215 at risk
EG0010 events0 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Urosepsis
Infections and infestations
MedDRA v 23.0 Mixed
Systematic Assessment
EG0001 events1 affected215 at risk
EG0010 events0 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v 23.0 Mixed
Systematic Assessment
EG0001 events1 affected215 at risk
EG0010 events0 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Adenocarcinoma gastric
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v 23.0 Mixed
Systematic Assessment
EG0000 events0 affected215 at risk
EG0011 events1 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v 23.0 Mixed
Systematic Assessment
EG0001 events1 affected215 at risk
EG0010 events0 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v 23.0 Mixed
Systematic Assessment
EG0000 events0 affected215 at risk
EG0011 events1 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Gallbladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v 23.0 Mixed
Systematic Assessment
EG0000 events0 affected215 at risk
EG0012 events1 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v 23.0 Mixed
Systematic Assessment
EG0001 events1 affected215 at risk
EG0010 events0 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Oesophageal carcinoma stage 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v 23.0 Mixed
Systematic Assessment
EG0001 events1 affected215 at risk
EG0010 events0 affected218 at risk
EG0020 events0 affected215 at risk
EG003
Parathyroid tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)