Neovascular Age-related Macular Degeneration
Conditions
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.
Interventions
DRUGFYB203 (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.
Sponsors
Bioeq GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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: 1. Not a woman of childbearing potential (WOCBP), OR 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness | Through study completion, until Week 56 (Visit 9) | 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 |
| 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 | Through study completion, until Week 56 (Week 9) | 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 |
| Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time | Through study completion, until Week 56 (Visit 9) | Percentage of patients with fluid-free macula at Baseline (Visit 1), Week 24 (Visit 5), Week 56 (Visit 9) - FAS |
| Evaluate and Compare Functional Changes of the Retina by BCVA Over Time | Through study completion, until Week 56 (Visit 9) | 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 |
| Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) | Through study completion, until Week 56 (Visit 9) | 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. |
| Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum | Through study completion, until Week 56 (Visit 9) | Number of patients with anti-drug antibodies (ADAs) at Baseline (Visit 1), Week 24 (Visit 5) and Week 56 (Visit 9) - SAF |
| Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) | Through study completion, until Week 56 (Visit 9) | Frequency of local and systemic adverse events (AEs) and serious adverse events (SAEs) - SAF |
| Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm) | At Baseline and Visit 3a (48 hours after the 3rd dose) | 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) |
Countries
Bulgaria, Czechia, Hungary, Israel, Italy, Japan, Poland, Russia, Ukraine
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 215 |
| 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. | 218 |
| Total | 433 |
Baseline characteristics
| Characteristic | FYB203 (Proposed Aflibercept Biosimilar) | Total | Eylea® (Aflibercept) |
|---|---|---|---|
| Age, Continuous | 73.7 years STANDARD_DEVIATION 7.72 | 73.5 years STANDARD_DEVIATION 7.71 | 73.3 years STANDARD_DEVIATION 7.7 |
| Age, Customized Age, Categorical >= 85 years | 17 Participants | 30 Participants | 13 Participants |
| Age, Customized Age, Categorical Between 18 and 64 years | 17 Participants | 42 Participants | 25 Participants |
| Age, Customized Age, Categorical Between 65 and 84 years | 181 Participants | 361 Participants | 180 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 212 Participants | 425 Participants | 213 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 33 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 197 Participants | 398 Participants | 201 Participants |
| Region of Enrollment Bulgaria | 10 participants | 21 participants | 11 participants |
| Region of Enrollment Czechia | 34 participants | 69 participants | 35 participants |
| Region of Enrollment Hungary | 34 participants | 68 participants | 34 participants |
| Region of Enrollment Israel | 6 participants | 12 participants | 6 participants |
| Region of Enrollment Italy | 9 participants | 18 participants | 9 participants |
| Region of Enrollment Japan | 17 participants | 33 participants | 16 participants |
| Region of Enrollment Poland | 37 participants | 77 participants | 40 participants |
| Region of Enrollment Russia | 35 participants | 71 participants | 36 participants |
| Region of Enrollment Ukraine | 33 participants | 64 participants | 31 participants |
| Sex: Female, Male Female | 121 Participants | 248 Participants | 127 Participants |
| Sex: Female, Male Male | 94 Participants | 185 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 215 | 1 / 218 | 0 / 215 | 0 / 218 | 0 / 215 | 0 / 218 |
| other Total, other adverse events | 56 / 215 | 46 / 218 | 44 / 215 | 49 / 218 | 37 / 215 | 32 / 218 |
| serious Total, serious adverse events | 17 / 215 | 23 / 218 | 2 / 215 | 2 / 218 | 0 / 215 | 3 / 218 |
Outcome results
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.
Time frame: Week 8
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| FYB203 (Proposed Aflibercept Biosimilar) | 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. | 6.6 letters | Standard Error 0.73 |
| Eylea® (Aflibercept) | 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. | 5.6 letters | Standard Error 0.73 |
90.4% CI: [-0.3, 2.2]
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.
Time frame: Through study completion, until Week 56 (Visit 9)
Population: FAS = Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) | to Week 24 (Visit 5) | 3.8 score points | Standard Deviation 11.06 |
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) | to Week 56 (Visit 9) | 3.8 score points | Standard Deviation 12.22 |
| Eylea® (Aflibercept) | Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) | to Week 24 (Visit 5) | 1.8 score points | Standard Deviation 10.97 |
| Eylea® (Aflibercept) | Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) | to Week 56 (Visit 9) | 1.7 score points | Standard Deviation 12.46 |
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
Time frame: Through study completion, until Week 56 (Visit 9)
Population: FAS = Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness | to Week 4 (Visit 2) | -163.9 μm | Standard Deviation 142.17 |
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness | to Week 24 (Visit 5) | -165.9 μm | Standard Deviation 174.98 |
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness | to Week 56 (Visit 9) | -188.4 μm | Standard Deviation 181.08 |
| Eylea® (Aflibercept) | Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness | to Week 4 (Visit 2) | -168.4 μm | Standard Deviation 126.36 |
| Eylea® (Aflibercept) | Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness | to Week 24 (Visit 5) | -172.4 μm | Standard Deviation 153 |
| Eylea® (Aflibercept) | Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness | to Week 56 (Visit 9) | -202.4 μm | Standard Deviation 156.96 |
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
Time frame: Through study completion, until Week 56 (Visit 9)
Population: FAS = Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare Functional Changes of the Retina by BCVA Over Time | to Week 24 (Visit 5) | 7.0 letters | Standard Deviation 9.45 |
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare Functional Changes of the Retina by BCVA Over Time | to Week 56 (Visit 9) | 8.3 letters | Standard Deviation 10.37 |
| Eylea® (Aflibercept) | Evaluate and Compare Functional Changes of the Retina by BCVA Over Time | to Week 24 (Visit 5) | 6.6 letters | Standard Deviation 9.51 |
| Eylea® (Aflibercept) | Evaluate and Compare Functional Changes of the Retina by BCVA Over Time | to Week 56 (Visit 9) | 6.6 letters | Standard Deviation 11.47 |
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)
Time frame: At Baseline and Visit 3a (48 hours after the 3rd dose)
Population: PKS = Plasma Concentration Analysis Set. Baseline values that were reported as \<LLOQ were analyzed with a numeric value of 0.5\*LLOQ.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm) | Baseline (Visit 1) | 2.000 ng/mL | Standard Deviation 0 |
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm) | Visit 3a (48h after 3rd dose) | 122.166 ng/mL | Standard Deviation 30.5161 |
| Eylea® (Aflibercept) | Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm) | Baseline (Visit 1) | 2.000 ng/mL | Standard Deviation 0 |
| Eylea® (Aflibercept) | Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm) | Visit 3a (48h after 3rd dose) | 120.112 ng/mL | Standard Deviation 28.9556 |
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
Time frame: Through study completion, until Week 56 (Visit 9)
Population: FAS = Full Analysis Set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time | Baseline (Visit 1) | Assessment / Response = Yes | 0 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time | Baseline (Visit 1) | Assessment / Response = No | 214 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time | Week 24 (Visit 5) | Assessment / Response = Yes | 71 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time | Week 24 (Visit 5) | Assessment / Response = No | 127 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time | Week 56 (Visit 9) | Assessment / Response = Yes | 79 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time | Week 56 (Visit 9) | Assessment / Response = No | 108 Participants |
| Eylea® (Aflibercept) | Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time | Week 56 (Visit 9) | Assessment / Response = Yes | 100 Participants |
| Eylea® (Aflibercept) | Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time | Baseline (Visit 1) | Assessment / Response = Yes | 0 Participants |
| Eylea® (Aflibercept) | Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time | Week 24 (Visit 5) | Assessment / Response = No | 135 Participants |
| Eylea® (Aflibercept) | Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time | Baseline (Visit 1) | Assessment / Response = No | 217 Participants |
| Eylea® (Aflibercept) | Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time | Week 56 (Visit 9) | Assessment / Response = No | 98 Participants |
| Eylea® (Aflibercept) | Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time | Week 24 (Visit 5) | Assessment / Response = Yes | 65 Participants |
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
Time frame: Through study completion, until Week 56 (Visit 9)
Population: SAF = Safety Analysis Set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum | Week 1 (Baseline) | Negative | 209 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum | Week 24 (Visit 5) | Negative | 191 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum | Week 1 (Baseline) | Positive | 4 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum | Week 56 (Visit 9) | Positive | 5 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum | Week 56 (Visit 9) | Negative | 189 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum | Week 24 (Visit 5) | Positive | 4 Participants |
| Eylea® (Aflibercept) | Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum | Week 56 (Visit 9) | Negative | 190 Participants |
| Eylea® (Aflibercept) | Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum | Week 1 (Baseline) | Positive | 3 Participants |
| Eylea® (Aflibercept) | Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum | Week 1 (Baseline) | Negative | 201 Participants |
| Eylea® (Aflibercept) | Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum | Week 24 (Visit 5) | Positive | 1 Participants |
| Eylea® (Aflibercept) | Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum | Week 24 (Visit 5) | Negative | 192 Participants |
| Eylea® (Aflibercept) | Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum | Week 56 (Visit 9) | Positive | 2 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
Time frame: Through study completion, until Week 56 (Week 9)
Population: FAS = Full Analysis Set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| FYB203 (Proposed Aflibercept Biosimilar) | 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 | to Week 24 (Visit 5) | > -5 and < 5 letters (gain or loss up to 4) | 52 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | 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 | to Week 56 (Visit 9) | ≥ 15 letters (gain 15 or more) | 52 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | 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 | to Week 24 (Visit 5) | ≥ 15 letters (gain 15 or more) | 45 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | 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 | to Week 56 (Visit 9) | ≥ 10 and < 15 letters (gain 10-14) | 43 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | 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 | to Week 24 (Visit 5) | > -10 and ≤ -5 letters (loss 5-9) | 12 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | 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 | to Week 56 (Visit 9) | ≥ 5 and < 10 letters (gain 5-9) | 34 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | 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 | to Week 24 (Visit 5) | ≥ 5 and < 10 letters (gain 5-9) | 41 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | 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 | to Week 56 (Visit 9) | > -5 and < 5 letters (gain or loss up to 4) | 39 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | 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 | to Week 56 (Visit 9) | > -10 and ≤ -5 letters (loss 5-9) | 12 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | 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 | to Week 24 (Visit 5) | > -15 and ≤ -10 letters (loss 10-14) | 6 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | 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 | to Week 56 (Visit 9) | > -15 and ≤ -10 letters (loss 10-14) | 6 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | 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 | to Week 24 (Visit 5) | ≥ 10 and < 15 letters (gain 10-14) | 41 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | 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 | to Week 56 (Visit 9) | ≤ -15 letters (loss 15 or more) | 2 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | 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 | to Week 24 (Visit 5) | ≤ -15 letters (loss 15 or more) | 4 Participants |
| Eylea® (Aflibercept) | 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 | to Week 56 (Visit 9) | ≤ -15 letters (loss 15 or more) | 9 Participants |
| Eylea® (Aflibercept) | 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 | to Week 24 (Visit 5) | ≥ 15 letters (gain 15 or more) | 38 Participants |
| Eylea® (Aflibercept) | 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 | to Week 24 (Visit 5) | ≥ 10 and < 15 letters (gain 10-14) | 39 Participants |
| Eylea® (Aflibercept) | 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 | to Week 24 (Visit 5) | ≥ 5 and < 10 letters (gain 5-9) | 47 Participants |
| Eylea® (Aflibercept) | 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 | to Week 24 (Visit 5) | > -5 and < 5 letters (gain or loss up to 4) | 58 Participants |
| Eylea® (Aflibercept) | 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 | to Week 24 (Visit 5) | > -10 and ≤ -5 letters (loss 5-9) | 13 Participants |
| Eylea® (Aflibercept) | 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 | to Week 24 (Visit 5) | > -15 and ≤ -10 letters (loss 10-14) | 2 Participants |
| Eylea® (Aflibercept) | 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 | to Week 24 (Visit 5) | ≤ -15 letters (loss 15 or more) | 6 Participants |
| Eylea® (Aflibercept) | 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 | to Week 56 (Visit 9) | ≥ 15 letters (gain 15 or more) | 49 Participants |
| Eylea® (Aflibercept) | 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 | to Week 56 (Visit 9) | ≥ 10 and < 15 letters (gain 10-14) | 36 Participants |
| Eylea® (Aflibercept) | 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 | to Week 56 (Visit 9) | ≥ 5 and < 10 letters (gain 5-9) | 39 Participants |
| Eylea® (Aflibercept) | 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 | to Week 56 (Visit 9) | > -10 and ≤ -5 letters (loss 5-9) | 13 Participants |
| Eylea® (Aflibercept) | 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 | to Week 56 (Visit 9) | > -15 and ≤ -10 letters (loss 10-14) | 7 Participants |
| Eylea® (Aflibercept) | 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 | to Week 56 (Visit 9) | > -5 and < 5 letters (gain or loss up to 4) | 48 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
Time frame: Through study completion, until Week 56 (Visit 9)
Population: SAF = Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FYB203 (Proposed Aflibercept Biosimilar) | Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) | local AEs, study eye | 67 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 19 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) | local AEs, fellow eye | 45 Participants |
| FYB203 (Proposed Aflibercept Biosimilar) | Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) | systemic AEs | 124 Participants |
| Eylea® (Aflibercept) | Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) | systemic AEs | 113 Participants |
| Eylea® (Aflibercept) | Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) | local AEs, fellow eye | 48 Participants |
| Eylea® (Aflibercept) | Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 28 Participants |
| Eylea® (Aflibercept) | Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs) | local AEs, study eye | 75 Participants |