<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04450329</url>
  </required_header>
  <id_info>
    <org_study_id>SB15-3001</org_study_id>
    <nct_id>NCT04450329</nct_id>
  </id_info>
  <brief_title>A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)</brief_title>
  <official_title>A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB15 (Proposed Aflibercept Biosimilar) and Eylea® in Subjects With Neovascular Age-related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Bioepis Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Bioepis Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomised, double-masked, parallel group, multicentre study to evaluate the&#xD;
      efficacy, safety, PK, and immunogenicity of SB15 compared to Eylea® in subjects with&#xD;
      neovascular AMD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be randomised in a 1:1 ratio to receive either SB15 or Eylea® (administered via&#xD;
      intravitreal [IVT] injection 2 mg [0.05 mL] every 4 weeks for the first 3 months (i.e., at&#xD;
      Weeks 0, 4, and 8), followed by 2 mg [0.05 mL] once every 8 weeks). At Week 32, subjects in&#xD;
      Eylea® treatment group will be randomised again in a 1:1 ratio to either continue on Eylea®&#xD;
      treatment or be transitioned to SB15 treatment. In the 8-week treatment cycle, IPs (SB15 or&#xD;
      Eylea®) will be administered up to Week 48, and the last assessment will be done at Week 56,&#xD;
      corresponding to the end of follow-up for all subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Actual">March 16, 2022</completion_date>
  <primary_completion_date type="Actual">April 15, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Best Corrected Visual Acuity (BCVA)</measure>
    <time_frame>Baseline and Week 8</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">449</enrollment>
  <condition>Neovascular Age-related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>SB15 (Proposed aflibercept biosimilar)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eylea (Aflibercept)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.&#xD;
At Week 32, subjects in Eylea group will re-randomized into SB15 or Eylea group. After re-randomization, subjects transited to SB15 group will receive SB15 2 mg (0.05 mL) once every 8 weeks until Week 48 and subjects remaining in Eylea group will continue to receive Eylea 2 mg (0.05 mL) once every 8 weeks until Week 48.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SB15 (Proposed aflibercept biosimilar)</intervention_name>
    <description>Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. Starting at Week 32, subjects transited from Eylea to SB15 will receive SB15 2 mg (0.05 mL) via intravitreal injection every 8 weeks.</description>
    <arm_group_label>Eylea (Aflibercept)</arm_group_label>
    <arm_group_label>SB15 (Proposed aflibercept biosimilar)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eylea (Aflibercept)</intervention_name>
    <description>Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.</description>
    <arm_group_label>Eylea (Aflibercept)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 50 years at Screening&#xD;
&#xD;
          2. Treatment naïve, *active subfoveal choroidal neovascularisation (CNV) lesion secondary&#xD;
             to AMD in the study eye&#xD;
&#xD;
          3. The area of CNV must occupy at least 50% of total lesion in the study eye&#xD;
&#xD;
          4. Total lesion area ≤ 9.0 Disc Areas (DA) in size (including blood, scars, and&#xD;
             neovascularisation) in the study eye&#xD;
&#xD;
          5. BCVA of 20/40 to 20/200 (letter score of 73 to 34, inclusive) using ETDRS charts or&#xD;
             2702 series Number charts in the study eye at Screening and at Week 0 (Day 1) prior to&#xD;
             randomisation&#xD;
&#xD;
          6. Non-childbearing potential female, OR childbearing potential female subjects or male&#xD;
             subjects with their (respectively male or female) partners who agree to use at least&#xD;
             two forms of appropriate contraception method that can achieve a failure rate of less&#xD;
             than 1% per year from Screening until 3 months after the last IVT injection of IP&#xD;
&#xD;
          7. Written informed consent form (ICF) must be obtained from the subject prior to any&#xD;
             study related procedure&#xD;
&#xD;
          8. Willingness and ability to undertake all scheduled visits and assessments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Study eye: Sub- or intra-retinal haemorrhage that comprises more than 50% of the&#xD;
             entire lesion or presence of blood with the size of 1 DA or more involving the centre&#xD;
             of fovea&#xD;
&#xD;
          2. Study eye: Scar, fibrosis, or atrophy involving the centre of the fovea&#xD;
&#xD;
          3. Study eye: Presence of CNV due to other causes, such as ocular histoplasmosis, trauma,&#xD;
             multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic&#xD;
             myopia&#xD;
&#xD;
          4. Study eye: Presence of retinal pigment epithelial tears or rips involving the macula&#xD;
&#xD;
          5. Study eye: Presence of macular hole at any stage&#xD;
&#xD;
          6. Study eye: Any concurrent macular abnormality other than AMD which could affect&#xD;
             central vision or the efficacy of IP&#xD;
&#xD;
          7. Study eye: Any concurrent ocular condition which, in the opinion of the Investigator,&#xD;
             could either confound the interpretation of efficacy and safety of IP or require&#xD;
             medical or surgical intervention during the study period&#xD;
&#xD;
          8. Either eye: History or clinical evidence of diabetic retinopathy (except for mild&#xD;
             non-proliferative diabetic retinopathy) or diabetic macular oedema (DME)&#xD;
&#xD;
          9. Study eye: Current vitreous haemorrhage&#xD;
&#xD;
         10. Either eye: Any previous IVT anti-vascular endothelial growth factor (VEGF) treatment&#xD;
&#xD;
         11. Any previous systemic anti-VEGF treatment&#xD;
&#xD;
         12. Study eye: History of treatment involving macula such as macular laser&#xD;
             photocoagulation, photodynamic therapy (PDT), transpupillary thermotherapy (TTT),&#xD;
             radiation therapy, or any ocular treatment for neovascular AMD&#xD;
&#xD;
         13. Any systemic treatment or therapy (including prescribed herbal medication) to treat&#xD;
             neovascular AMD within 30 days prior to randomisation. However, dietary supplements,&#xD;
             vitamins, or minerals will be allowed.&#xD;
&#xD;
         14. Study eye: History of vitrectomy, scleral buckling (encircling), glaucoma filtration&#xD;
             surgery, corneal transplantation, or pan-retinal photocoagulation&#xD;
&#xD;
         15. Study eye: Previous ocular (intraocular and peribulbar) corticosteroids&#xD;
             injection/implant within 1 year prior to randomisation&#xD;
&#xD;
         16. Study eye: Topical ocular corticosteroids administered for ≥ 30 consecutive days or&#xD;
             for ≥ 60 nonconsecutive days within 90 days prior to randomisation&#xD;
&#xD;
         17. Use of systemic corticosteroids for 30 or more consecutive days within 90 days prior&#xD;
             to randomization (inhaled steroid is permitted).&#xD;
&#xD;
         18. Study eye: Any other intraocular surgery or periocular surgery within 90 days prior to&#xD;
             randomisation, except for lid surgery, which may not have taken place within 30 days&#xD;
             prior to randomisation.&#xD;
&#xD;
         19. Current use of medications known to be toxic to the lens, retina, or optic nerve at&#xD;
             Screening.&#xD;
&#xD;
         20. Study eye: Previous radiation therapy near the region of the study eye&#xD;
&#xD;
         21. Previous participation in clinical studies with IP to treat neovascular AMD in either&#xD;
             eye.&#xD;
&#xD;
         22. Previous participation in clinical studies with IP to treat disease other than&#xD;
             neovascular AMD within 90 days prior to randomisation (excluding dietary&#xD;
             supplementary, vitamins, and minerals).&#xD;
&#xD;
         23. Subject with only one functional eye (defined as BCVA of counting finger or less on&#xD;
             the eye with worse vision)&#xD;
&#xD;
         24. Study eye: Spherical equivalent of the refractive error demonstrating more than 6&#xD;
             diopters of myopia. For subjects who have undergone previous refractive or cataract&#xD;
             surgery in the study eye, the preoperative refractive error in the study eye cannot&#xD;
             exceed 6 diopters of myopia.&#xD;
&#xD;
         25. Study eye: Aphakia or absence of the posterior capsule (unless it occurred as a result&#xD;
             of a YAG laser posterior capsulotomy in association with prior posterior chamber IOL&#xD;
             implantation)&#xD;
&#xD;
         26. Either eye: Active or suspected ocular and periocular infection at Screening or at&#xD;
             randomisation&#xD;
&#xD;
         27. Either eye: Active intraocular inflammation including scleritis at Screening or at&#xD;
             randomisation&#xD;
&#xD;
         28. Either eye: History of idiopathic or autoimmune-associated uveitis&#xD;
&#xD;
         29. Study eye: Uncontrolled ocular hypertension (defined as intraocular pressure [IOP] ≥&#xD;
             25 mmHg despite treatment with anti-glaucoma medication) at Screening&#xD;
&#xD;
         30. Known allergic reactions and/or hypersensitivity to any component of Eylea or SB15&#xD;
&#xD;
         31. History of allergy to the fluorescein sodium for injection in angiography&#xD;
&#xD;
         32. History of a medical condition that would preclude scheduled study visits or safe use&#xD;
             of IP in the opinion of the Investigator&#xD;
&#xD;
         33. Uncontrolled systemic disease including but not limited to uncontrolled diabetes&#xD;
             mellitus (in the opinion of the Investigator), uncontrolled systemic hypertension&#xD;
             (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg on&#xD;
             optimal medical regimen), or uncontrolled atrial fibrillation (resting heart rate ≥&#xD;
             110 beats per minutes) at Screening&#xD;
&#xD;
         34. Stroke, transient ischaemic attacks, or myocardial infarction within 180 days prior to&#xD;
             randomisation&#xD;
&#xD;
         35. History of recurrent significant infections and/or current treatment for systemic&#xD;
             infection&#xD;
&#xD;
         36. Severe renal impairment with dialysis or a history of renal transplant&#xD;
&#xD;
         37. Malignancy (other than non-melanoma skin cancer) under treatment or with history of&#xD;
             metastatic disease&#xD;
&#xD;
         38. Women of childbearing potential who are pregnant, planning to become pregnant,&#xD;
             lactating, or not using adequate birth control, as specified in protocol. For women of&#xD;
             childbearing potential, a serum pregnancy test must result negative at Screening.&#xD;
&#xD;
         39. Employees of investigational sites, individuals directly involved with the conduct of&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Se Joon Woo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital, South Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Abilene</city>
        <state>Texas</state>
        <zip>79606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Osijek</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Rijeka</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Brno</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Hradec Králové</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Praha 10</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Praha 5</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Kohtla-Järve</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Tallinn</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Pécs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Szeged</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Zalaegerszeg</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Aichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Inashiki-gun</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Kagoshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Nagasaki-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Ansan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Seongnam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Bydgoszcz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Tarnów</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Łódź</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Kovrov</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Novosibirsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SB Investigative Site</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>Hungary</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Latvia</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <disposition_first_submitted>April 12, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>April 12, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 15, 2022</disposition_first_posted>
  <last_update_submitted>April 12, 2022</last_update_submitted>
  <last_update_submitted_qc>April 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Wet Macular Degeneration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aflibercept</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04450329
org study id: SB15-3001
nct id: NCT04450329
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a randomised, double-masked, parallel group, multicentre study to evaluate the
      efficacy, safety, PK, and immunogenicity of SB15 compared to Eylea® in subjects with
      neovascular AMD.
Subjects will be randomised in a 1:1 ratio to receive either SB15 or Eylea® (administered via
      intravitreal [IVT] injection 2 mg [0.05 mL] every 4 weeks for the first 3 months (i.e., at
      Weeks 0, 4, and 8), followed by 2 mg [0.05 mL] once every 8 weeks). At Week 32, subjects in
      Eylea® treatment group will be randomised again in a 1:1 ratio to either continue on Eylea®
      treatment or be transitioned to SB15 treatment. In the 8-week treatment cycle, IPs (SB15 or
      Eylea®) will be administered up to Week 48, and the last assessment will be done at Week 56,
      corresponding to the end of follow-up for all subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in Best Corrected Visual Acuity (BCVA)
time frame: Baseline and Week 8
arm group label: SB15 (Proposed aflibercept biosimilar)
arm group type: Experimental
description: Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.
arm group label: Eylea (Aflibercept)
arm group type: Active Comparator
description: Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.
At Week 32, subjects in Eylea group will re-randomized into SB15 or Eylea group. After re-randomization, subjects transited to SB15 group will receive SB15 2 mg (0.05 mL) once every 8 weeks until Week 48 and subjects remaining in Eylea group will continue to receive Eylea 2 mg (0.05 mL) once every 8 weeks until Week 48.
intervention type: Drug
intervention name: SB15 (Proposed aflibercept biosimilar)
description: Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. Starting at Week 32, subjects transited from Eylea to SB15 will receive SB15 2 mg (0.05 mL) via intravitreal injection every 8 weeks.
arm group label: Eylea (Aflibercept)
arm group label: SB15 (Proposed aflibercept biosimilar)
intervention type: Drug
intervention name: Eylea (Aflibercept)
description: Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.
arm group label: Eylea (Aflibercept)
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Se Joon Woo
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital, South Korea
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country: Croatia
country: Czechia
country: Estonia
country: Hungary
country: Japan
country: Korea, Republic of
country: Latvia
country: Poland
country: Russian Federation
country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Wet Macular Degeneration
mesh term: Aflibercept