Neovascular Age-related Macular Degeneration
Conditions
Brief summary
Purpose and rationale: To demonstrate similar efficacy, safety and immunogenicity of SOK583A1 and Eylea EU as per Eylea approved treatment regimen in patients with nAMD. The primary clinical question of interest is: Does SOK583A1 have similar efficacy as Eylea EU in terms of mean change in BCVA score in participants with nAMD who are anti-VEGF naive, without important protocol deviations and adherent to the treatment and completed the treatment to Week 8?
Detailed description
BCVA: Best-Corrected Visual Acuity Eylea EU: Europe-authorized Eylea® nAMD: Neovascular Age-related Macular Degeneration VEGF: Vascular Endothelium Growth Factor
Interventions
BIOLOGICALSOK583A1 (40 mg/mL)
IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
BIOLOGICALEylea EU (40 mg/mL)
IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
Sponsors
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants eligible for inclusion in this study must meet all of the following criteria: 1. Signed informed consent must be obtained prior to participation in the study 2. Participants must be 50 years of age or older at Screening 3. Anti-VEGF treatment-naive patients for either eye and systemically 4. Study eye diagnosed with active CNV lesions (type 1 and/ or type 2) secondary to AMD and/or Retinal Angiomatous Proliferation lesions (type 3), affecting the central subfield. Active CNV lesion is defined by the presence of leakage as evidenced by fluorescein angiography, and intra- or subretinal fluid as evidenced by optical coherence tomography, both confirmed by the CRC at Screening 5. Total area of CNV (including both classic and occult components) must comprise \> 50% of the total lesion area in the study eye, confirmed by the CRC at Screening 6. BCVA between 73 and 38 letters, both inclusive, in the study eye at Screening and Baseline using ETDRS testing charts 7. Willing and able to comply with all study procedures, and be likely to complete the study 8. Clear ocular media and adequate pupil dilatation in both eyes to permit good quality photographic imaging. Participants meeting any of the following criteria are not eligible for inclusion in this study. Ocular conditions and treatments: 1. Previous treatment with any anti-VEGF therapy in either eye or investigational drugs in study eye or fellow eye, at any time prior to Baseline 2. Participant has received any approved treatment for nAMD (other than vitamin and dietary supplements) in the study eye and at any time prior to Baseline 3. Presence of other causes of CNV, including pathologic myopia (spherical equivalent of -8 diopters or more negative), ocular histoplasmosis syndrome, angioid streaks,choroidal rupture, or multifocal choroiditis in the study eye, assessed by imaging at screening by CRC and appropriately stated in the multi-modal eligibility confirmation report 4. Any active or suspected intraocular or periocular infection or suspected active intraocular inflammation (e.g infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in either eye at Screening or Baseline 5. Subfoveal fibrosis, atrophy, or scarring extending \> 50% of total lesion area in the study eye as assessed by the Investigator at Screening and confirmed by the CRC prior to randomization 6. Subretinal hemorrhage that is ≥ 50% of the total lesion area in the study eye, or if the subretinal hemorrhage involving the fovea is 1 or more disc areas (≥ 2.54 mm2 ) in size in the study eye, as assessed by Fluorescein Angiography (FA) and confirmed by the CRC 7. Retinal pigment epithelium (RPE) rip/tear in the study eye at Screening or Baseline 8. Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline 9. History or evidence of the following, in the study eye: * Intraocular (including cataract surgery) or refractive surgery within the 90 day period prior to Baseline. The yttrium aluminum garnet (YAG) posterior capsulotomy is allowed no later than 4 weeks prior to Baseline * Previous penetrating keratoplasty or vitrectomy * Previous panretinal photocoagulation * Previous photodynamic therapy * Previous submacular surgery or other surgical intervention for AMD * Retinal detachment or treatment or surgery for retinal detachment * Any history of macular hole of stage 2 and above * Prior trabeculectomy or other filtration surgery * Ocular trauma within the 6-months period prior to Baseline 10. History of hypersensitivity to any of the study treatments or its excipients, or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigators 11. Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 mmHg on medication or according to Investigator's judgment at Screening or Baseline 12. Aphakia and/or absence of the posterior capsule in the study eye at Screening or Baseline, unless it occurred as a result of a YAG posterior capsulotomy in association with prior posterior chamber intraocular lens implantation 13. Intra or periocular use of corticosteroids in the study eye within a 6 month period prior to Baseline 14. Use of topical ocular corticosteroids in the study eye for 30 or more consecutive days within the 90 days period prior to Baseline 15. Previous therapeutic radiation near the region of the study eye 16. Concomitant conditions or ocular disorders in the study eye, including media opacities, cataract and diabetic macular edema, at Screening or Baseline which could, in the opinion of the Investigator, prevent response to study treatment or may confound interpretation of study results (efficacy and safety), compromise visual acuity or require medical or surgical intervention during the course of the study 17. Presence of amblyopia, amaurosis or ocular disorders with BCVA \<38 letters (ETDRS testing charts) in the fellow eye at Screening (except when due to conditions whose surgery may improve VA, e.g. cataract) 18. Presence of Scleromalacia in either eye 19. Participants requiring anti-VEGF treatment of the fellow eye at Baseline will not be eligible for the PK substudy Systemic conditions and treatments: 20. Previous systemic treatment with any anti-VEGF therapy 21. Use of systemic corticosteroids for 30 or more consecutive days within the 90 days prior to Baseline, with the exception of low stable doses of corticosteroids (defined as ≤ 10 mg prednisolone or equivalent dose used for 90 days or more). 22. Uncontrolled blood pressure defined as a systolic value ≥ 160 mmHg or diastolic value ≥ 100 mmHg at Screening 23. Stroke or myocardial infarction during the 6-month period prior to Baseline 24. Participation in an investigational systemic drug, biologic, or device study within 30 days or duration of 5 half-lives of the investigational product (whichever is longer) prior to Baseline. Note: observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary 25. Presence of infection at screening or active infection within 2 weeks before screening 26. Underlying advanced, severe and uncontrolled concomitant condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, inflammatory, infectious or gastrointestinal), physical examination finding, or clinical laboratory finding which in the opinion of the Investigator place the participant at unacceptable risk from participation in the study 27. History of a medical condition (including, but not limited to chronic disease immunosuppression, metabolic dysfunction, prior exposure to other drugs that may pose risk of infection or allergic reactions) that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product, or that might affect participant safety or interpretation of the study results. 28. Pregnant or nursing (lactating) women and women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 3 months after stopping the medication. Highly effective contraception methods include: * Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. * Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant. * Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best-Corrected Visual Acuity (BCVA) Will be Assessed Using the ETDRS Testing Charts at an Initial Distance of 4 Meters. The Change From Baseline in BCVA in Letters is Defined as Difference Between BCVA Score Between Week 8 and Baseline. | Change from baseline in mean BCVA score at Week 8 | The primary aim of the study is to demonstrate equivalence of change in BCVA score from Baseline at Week 8 between participants with nAMD treated with SOK583A1 and participants treated with Eylea EU. The primary analysis will be performed on the Per-Protocol Set (PPS), which is the most appropriate analysis set to use when testing for equivalence. ETDRS: Early Treatment Diabetic Retinopathy Study EU: European |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU | Week 1, 4, 8, 24 and 52 | Mean change in CSFT using SD-OCT from Baseline to Week 1, 4, 8, 24 and 52 CSFT: Central Subfield Thickness SD-OCT: Spectral-Domain Optical Coherence Tomography |
| Similarity of Efficacy Between SOK583A1 and Eylea EU in Terms of BCVA | Week 24 and 52 | Mean change from Baseline in BCVA score using EDTRS testing charts at Week 24 and 52 |
| Similarity Between SOK583A1 and Eylea EU in Terms of Immunogenicity | Week 52 | Development of binding and neutralizing Anti-drug antibodies (ADAs) up to Week 52 |
| Systemic Exposure to SOK583A1 and Eylea EU in Participants of the Pharmacokinetic (PK) Assessment | Baseline (pre-dose) and 24 hours after the first injection (day 2) and third injection (day 58) | Aflibercept concentration assessments at Baseline (pre-dose) and 24 hours after the first and third injections |
| Similarity Between SOK583A1 and Eylea EU in Terms of Safety | 52 weeks | Number and proportion of subjects with ocular and non-ocular Adverse Events (AEs) over 52 weeks including serious AEs, regardless of relationship to study treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Analysis Systemic VEGF Concentrations in Patients Treated With Aflibercept | Assessment at Week 48 (pre-dose) and Week 52 | Mean VEGF concentrations |
Countries
Australia, Austria, Bulgaria, Czechia, France, Germany, Hungary, Israel, Japan, Latvia, Lithuania, Poland, Portugal, Slovakia, Spain, United States
Participant flow
Pre-assignment details
485 subjects were randomized in the study, and 484 subjects received at least 1 dose of SOK583 or Eylea EU and comprised the Safety Set. Of these 484 subject, 1 subject in the SOK583 group had no post-baseline BCVA assessments and was therefore excluded from the Full Analysis Set. The Full Analysis Set therefore comprises 483 subjects.
Participants by arm
| Arm | Count |
|---|---|
| SOK583A1 (40 mg/mL) Intravitreal (IVT) administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
SOK583A1 (40 mg/mL): IVT administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48. | 243 |
| Eylea EU (40 mg/mL) IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
EU: European
Eylea EU (40 mg/mL): IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48. | 240 |
| Total | 483 |
Baseline characteristics
| Characteristic | SOK583A1 (40 mg/mL) | Eylea EU (40 mg/mL) | Total |
|---|---|---|---|
| Age, Continuous | 75.8 years STANDARD_DEVIATION 7.82 | 75.7 years STANDARD_DEVIATION 7.72 | 75.7 years STANDARD_DEVIATION 7.76 |
| Age, Customized <75 years | 103 Participants | 98 Participants | 201 Participants |
| Age, Customized ≥75 years | 140 Participants | 142 Participants | 282 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 9 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 225 Participants | 225 Participants | 450 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 12 Participants | 28 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 13 Participants | 25 Participants |
| Race (NIH/OMB) White | 215 Participants | 214 Participants | 429 Participants |
| Region of Enrollment Australia | 10 Participants | 13 Participants | 23 Participants |
| Region of Enrollment Europe | 158 Participants | 161 Participants | 319 Participants |
| Region of Enrollment Israel | 15 Participants | 12 Participants | 27 Participants |
| Region of Enrollment Japan | 14 Participants | 12 Participants | 26 Participants |
| Region of Enrollment United States | 46 Participants | 42 Participants | 88 Participants |
| Sex: Female, Male Female | 137 Participants | 136 Participants | 273 Participants |
| Sex: Female, Male Male | 106 Participants | 104 Participants | 210 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 244 | 1 / 240 |
| other Total, other adverse events | 58 / 244 | 63 / 240 |
| serious Total, serious adverse events | 39 / 244 | 30 / 240 |
Outcome results
Primary
Best-Corrected Visual Acuity (BCVA) Will be Assessed Using the ETDRS Testing Charts at an Initial Distance of 4 Meters. The Change From Baseline in BCVA in Letters is Defined as Difference Between BCVA Score Between Week 8 and Baseline.
The primary aim of the study is to demonstrate equivalence of change in BCVA score from Baseline at Week 8 between participants with nAMD treated with SOK583A1 and participants treated with Eylea EU. The primary analysis will be performed on the Per-Protocol Set (PPS), which is the most appropriate analysis set to use when testing for equivalence. ETDRS: Early Treatment Diabetic Retinopathy Study EU: European
Time frame: Change from baseline in mean BCVA score at Week 8
Population: Per-Protocol Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOK583A1 (40 mg/mL) | Best-Corrected Visual Acuity (BCVA) Will be Assessed Using the ETDRS Testing Charts at an Initial Distance of 4 Meters. The Change From Baseline in BCVA in Letters is Defined as Difference Between BCVA Score Between Week 8 and Baseline. | 6.5 BCVA score in letters | Standard Deviation 8.98 |
| Eylea EU (40 mg/mL) | Best-Corrected Visual Acuity (BCVA) Will be Assessed Using the ETDRS Testing Charts at an Initial Distance of 4 Meters. The Change From Baseline in BCVA in Letters is Defined as Difference Between BCVA Score Between Week 8 and Baseline. | 6.8 BCVA score in letters | Standard Deviation 7.46 |
Secondary
Similarity Between SOK583A1 and Eylea EU in Terms of Immunogenicity
Development of binding and neutralizing Anti-drug antibodies (ADAs) up to Week 52
Time frame: Week 52
Population: Immunogenicity analysis set including all randomized subjects who received at least 1 dose of study treatment and had immunogenicity blood samples collected and analyzed at baseline and at least 1 post-baseline time point. Subjects with positive ADA results at baseline were excluded from the IAS. Subjects who received both treatments into the study eye were excluded from the IAS. Subjects were analyzed according to the study treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SOK583A1 (40 mg/mL) | Similarity Between SOK583A1 and Eylea EU in Terms of Immunogenicity | ADA positive | 2 Participants |
| SOK583A1 (40 mg/mL) | Similarity Between SOK583A1 and Eylea EU in Terms of Immunogenicity | ADA negative | 232 Participants |
| Eylea EU (40 mg/mL) | Similarity Between SOK583A1 and Eylea EU in Terms of Immunogenicity | ADA positive | 6 Participants |
| Eylea EU (40 mg/mL) | Similarity Between SOK583A1 and Eylea EU in Terms of Immunogenicity | ADA negative | 225 Participants |
Secondary
Similarity Between SOK583A1 and Eylea EU in Terms of Safety
Number and proportion of subjects with ocular and non-ocular Adverse Events (AEs) over 52 weeks including serious AEs, regardless of relationship to study treatment
Time frame: 52 weeks
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SOK583A1 (40 mg/mL) | Similarity Between SOK583A1 and Eylea EU in Terms of Safety | Ocular AEs in the study eye | 84 Participants |
| SOK583A1 (40 mg/mL) | Similarity Between SOK583A1 and Eylea EU in Terms of Safety | Ocular AEs in the fellow eye | 55 Participants |
| SOK583A1 (40 mg/mL) | Similarity Between SOK583A1 and Eylea EU in Terms of Safety | Non-ocular AEs | 141 Participants |
| Eylea EU (40 mg/mL) | Similarity Between SOK583A1 and Eylea EU in Terms of Safety | Ocular AEs in the study eye | 78 Participants |
| Eylea EU (40 mg/mL) | Similarity Between SOK583A1 and Eylea EU in Terms of Safety | Ocular AEs in the fellow eye | 51 Participants |
| Eylea EU (40 mg/mL) | Similarity Between SOK583A1 and Eylea EU in Terms of Safety | Non-ocular AEs | 141 Participants |
Secondary
Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU
Mean change of CNV lesion size using FA from Screening to Week 8 and 52 CNV: Choroidal neovascularization FA: Fundus Angiography
Time frame: Week 8 and 52
Population: Full Analysis Set (subjects with baseline value). Results are provided for subjects with data available at a certain visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOK583A1 (40 mg/mL) | Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU | Week 8 | -1.7877 mm^2 | Standard Deviation 3.97567 |
| SOK583A1 (40 mg/mL) | Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU | Week 52 | -3.7845 mm^2 | Standard Deviation 5.21911 |
| Eylea EU (40 mg/mL) | Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU | Week 8 | -1.7274 mm^2 | Standard Deviation 3.77398 |
| Eylea EU (40 mg/mL) | Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU | Week 52 | -3.5026 mm^2 | Standard Deviation 4.96036 |
Secondary
Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU
Mean change in CSFT using SD-OCT from Baseline to Week 1, 4, 8, 24 and 52 CSFT: Central Subfield Thickness SD-OCT: Spectral-Domain Optical Coherence Tomography
Time frame: Week 1, 4, 8, 24 and 52
Population: Full Analysis Set (subjects with baseline value). Results are provided for subjects with data available at a certain visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOK583A1 (40 mg/mL) | Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU | Week 4 | -152.9 μm | Standard Deviation 123.55 |
| SOK583A1 (40 mg/mL) | Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU | Week 24 | -136.4 μm | Standard Deviation 140.19 |
| SOK583A1 (40 mg/mL) | Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU | Week 8 | -165.7 μm | Standard Deviation 144.35 |
| SOK583A1 (40 mg/mL) | Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU | Week 52 | -187.9 μm | Standard Deviation 150.7 |
| SOK583A1 (40 mg/mL) | Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU | Week 1 | -103.6 μm | Standard Deviation 89.91 |
| Eylea EU (40 mg/mL) | Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU | Week 52 | -172.9 μm | Standard Deviation 142.74 |
| Eylea EU (40 mg/mL) | Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU | Week 1 | -99.2 μm | Standard Deviation 86.18 |
| Eylea EU (40 mg/mL) | Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU | Week 4 | -140.7 μm | Standard Deviation 120.25 |
| Eylea EU (40 mg/mL) | Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU | Week 8 | -154.2 μm | Standard Deviation 133.43 |
| Eylea EU (40 mg/mL) | Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU | Week 24 | -127.5 μm | Standard Deviation 137.87 |
Secondary
Similarity of Efficacy Between SOK583A1 and Eylea EU in Terms of BCVA
Mean change from Baseline in BCVA score using EDTRS testing charts at Week 24 and 52
Time frame: Week 24 and 52
Population: Full Analysis Set (subjects with baseline value). Results are provided for subjects with data available at a certain visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOK583A1 (40 mg/mL) | Similarity of Efficacy Between SOK583A1 and Eylea EU in Terms of BCVA | Week 24 | 6.9 score on a scale | Standard Deviation 8.93 |
| SOK583A1 (40 mg/mL) | Similarity of Efficacy Between SOK583A1 and Eylea EU in Terms of BCVA | Week 52 | 6.4 score on a scale | Standard Deviation 11.91 |
| Eylea EU (40 mg/mL) | Similarity of Efficacy Between SOK583A1 and Eylea EU in Terms of BCVA | Week 24 | 7.4 score on a scale | Standard Deviation 9.95 |
| Eylea EU (40 mg/mL) | Similarity of Efficacy Between SOK583A1 and Eylea EU in Terms of BCVA | Week 52 | 7.7 score on a scale | Standard Deviation 11.62 |
Secondary
Systemic Exposure to SOK583A1 and Eylea EU in Participants of the Pharmacokinetic (PK) Assessment
Aflibercept concentration assessments at Baseline (pre-dose) and 24 hours after the first and third injections
Time frame: Baseline (pre-dose) and 24 hours after the first injection (day 2) and third injection (day 58)
Population: PK Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOK583A1 (40 mg/mL) | Systemic Exposure to SOK583A1 and Eylea EU in Participants of the Pharmacokinetic (PK) Assessment | Day 1 (Baseline) | 0.0 ng/ml | Standard Deviation 0 |
| SOK583A1 (40 mg/mL) | Systemic Exposure to SOK583A1 and Eylea EU in Participants of the Pharmacokinetic (PK) Assessment | Day 2 | 32.0 ng/ml | Standard Deviation 24 |
| SOK583A1 (40 mg/mL) | Systemic Exposure to SOK583A1 and Eylea EU in Participants of the Pharmacokinetic (PK) Assessment | Day 58 | 31.7 ng/ml | Standard Deviation 21.9 |
| Eylea EU (40 mg/mL) | Systemic Exposure to SOK583A1 and Eylea EU in Participants of the Pharmacokinetic (PK) Assessment | Day 1 (Baseline) | 0.0 ng/ml | Standard Deviation 0 |
| Eylea EU (40 mg/mL) | Systemic Exposure to SOK583A1 and Eylea EU in Participants of the Pharmacokinetic (PK) Assessment | Day 2 | 33.3 ng/ml | Standard Deviation 24.6 |
| Eylea EU (40 mg/mL) | Systemic Exposure to SOK583A1 and Eylea EU in Participants of the Pharmacokinetic (PK) Assessment | Day 58 | 33.6 ng/ml | Standard Deviation 25.8 |
Other Pre-specified
Analysis Systemic VEGF Concentrations in Patients Treated With Aflibercept
Mean VEGF concentrations
Time frame: Assessment at Week 48 (pre-dose) and Week 52
Population: VEGF Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOK583A1 (40 mg/mL) | Analysis Systemic VEGF Concentrations in Patients Treated With Aflibercept | Week 52 | 75.14 pg/mL | Standard Deviation 20.892 |
| SOK583A1 (40 mg/mL) | Analysis Systemic VEGF Concentrations in Patients Treated With Aflibercept | Week 48 (pre-dose) | 86.44 pg/mL | Standard Deviation 77.962 |
| Eylea EU (40 mg/mL) | Analysis Systemic VEGF Concentrations in Patients Treated With Aflibercept | Week 48 (pre-dose) | 80.09 pg/mL | Standard Deviation 92.155 |
| Eylea EU (40 mg/mL) | Analysis Systemic VEGF Concentrations in Patients Treated With Aflibercept | Week 52 | 73.38 pg/mL | Standard Deviation 20.169 |