<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/NCT04480463</url>
  </required_header>
  <id_info>
    <org_study_id>SCD411-CP101</org_study_id>
    <nct_id>NCT04480463</nct_id>
  </id_info>
  <brief_title>A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD)</brief_title>
  <official_title>A Phase III Randomized, Double-Masked, Parallel Group, Multicenter Study to Compare the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity Between SCD411 and Eylea® in Subjects With Neovascular Age-related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sam Chun Dang Pharm. Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sam Chun Dang Pharm. Co. Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Age-related macular degeneration (AMD) is a leading cause of vision loss in adults. Abnormal&#xD;
      blood vessels grow under the macula at the back of the eye, and also leak blood and fluid,&#xD;
      which damages and scars the macula, affecting vision. The current standard of care for&#xD;
      patients with neovascular (exudative / wet) AMD is anti-vascular endothelial growth factor&#xD;
      (anti-VEGF) therapy, which prevents or slows down the growth of the abnormal blood vessels.&#xD;
      SCD411 is being developed as a biosimilar to the reference product Eylea® (aflibercept), an&#xD;
      anti-VEGF drug. The study aims to prove equivalence of SCD411 to Eylea in adults with wet&#xD;
      AMD, and will look at safety, tolerance, effectiveness, immune response and the movement of&#xD;
      the drug through the body.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 13, 2020</start_date>
  <completion_date type="Anticipated">September 2022</completion_date>
  <primary_completion_date type="Actual">November 2, 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>
    <masking_description>Only the unmasked investigator involved in performing the IVT injections will be unmasked to study treatment. These individuals are not allowed to discuss treatment and/or subject outcome with masked study staff, including the evaluating investigator.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in BCVA (best corrected visual acuity)</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in BCVA (best corrected visual acuity)</measure>
    <time_frame>Baseline to Week 52</time_frame>
    <description>Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with anti-SCD411 antibodies</measure>
    <time_frame>Baseline, Weeks 4, 8, 20, 36 and 52</time_frame>
    <description>Assessed by blood samples</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">576</enrollment>
  <condition>Wet Age-related Macular Degeneration</condition>
  <condition>Neovascular Age-related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>SCD411</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Aflibercept</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SCD411</intervention_name>
    <description>IVT (intravitreal) injection</description>
    <arm_group_label>SCD411</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aflibercept</intervention_name>
    <description>IVT injection</description>
    <arm_group_label>Aflibercept</arm_group_label>
    <other_name>Eylea®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provides written informed consent.&#xD;
&#xD;
          -  Clinical diagnosis of wet (neovascular) age-related macular degeneration (AMD).&#xD;
&#xD;
          -  BCVA (best corrected visual acuity) letter score of 73 to 35 at screening and prior to&#xD;
             randomization.&#xD;
&#xD;
          -  Women of child-bearing potential with negative serum pregnancy test at screening must&#xD;
             agree to use protocol-defined methods of contraception throughout study until 3 months&#xD;
             after last injection of aflibercept/SCD411.&#xD;
&#xD;
          -  Males with female partners of child-bearing potential must agree to use&#xD;
             protocol-defined methods of contraception and refrain from donating sperm throughout&#xD;
             study until 3 months after last injection of aflibercept/SCD411.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any prior eye (study eye and fellow eye) or systemic treatment or surgery for&#xD;
             neovascular AMD, except dietary supplements or vitamins.&#xD;
&#xD;
          -  Any prior or current treatment with another investigational agent to great neovascular&#xD;
             AMD in the study eye, except dietary supplements or vitamins.&#xD;
&#xD;
          -  Fellow eye shows signed of AMD that may need treatment during study period.&#xD;
&#xD;
          -  Any prior treatment with anti-VEGF agents in both eyes.&#xD;
&#xD;
          -  Blood, scars, atrophy, fibrosis, and neovascularization, based on assessment at&#xD;
             screening.&#xD;
&#xD;
          -  Central retina thickness of &lt;300 µm in the study eye.&#xD;
&#xD;
          -  Subretinal hemorrhage.&#xD;
&#xD;
          -  Scar or fibrosis.&#xD;
&#xD;
          -  Scar, fibrosis, or atrophy in the study eye.&#xD;
&#xD;
          -  Presence of retinal pigment epithelial tears or rips involving the macular in the&#xD;
             study eye.&#xD;
&#xD;
          -  Cataract in the study eye that, in the Investigator's opinion, interferes with&#xD;
             visualization of retina or retinal imaging.&#xD;
&#xD;
          -  Inflammation outside the eyeball in either eye, or within the eyeball of the study&#xD;
             eye.&#xD;
&#xD;
          -  History of any vitreous hemorrhage in the study eye.&#xD;
&#xD;
          -  History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any&#xD;
             other vascular disease.&#xD;
&#xD;
          -  History of, treatment or surgery for detached retina.&#xD;
&#xD;
          -  History of uncomplicated surgery within the eyeball or around the study eye, except&#xD;
             lid surgery.&#xD;
&#xD;
          -  Absence of lens in study eye.&#xD;
&#xD;
          -  Uncontrolled hypertension, defined as systolic blood pressure (BP) &gt;180 mmHg or&#xD;
             diastolic BP &gt;100 mmHg under appropriate antihypertensive treatment.&#xD;
&#xD;
          -  Hypersensitivity to aflibercept or medications used in the study (fluorescein,&#xD;
             mydriatic eye drops, etc.).&#xD;
&#xD;
          -  Pregnancy or lactation at Screening or at baseline for women of child-bearing&#xD;
             potential.&#xD;
&#xD;
          -  History of blood clotting events.&#xD;
&#xD;
          -  History or evidence of cardiac conditions, or inability to perform any physical&#xD;
             activity without discomfort; ventricular arrhythmia; and atrial fibrillation.&#xD;
&#xD;
          -  History of laser therapy in the macular region.&#xD;
&#xD;
          -  Any prior or current treatment with corticosteroids inside or immediately around the&#xD;
             study eye.&#xD;
&#xD;
          -  Any prior or current treatment involving the macula with photodynamic therapy (PDT)&#xD;
             with verteporfin, transpupillary thermotherapy, radiation therapy, or retinal laser&#xD;
             treatment in the study eye.&#xD;
&#xD;
          -  Any prior or current treatment with pan-retinal photocoagulation.&#xD;
&#xD;
          -  Any prior or current treatment with ethambutol; deferoxamine and topiramate;&#xD;
             tamoxifen, hydroxychloroquine, chloroquine, or vigabatrin; and amiodarone.&#xD;
&#xD;
          -  Any investigational product for the treatment of eye conditions and systemic&#xD;
             conditions, 30 days or 5 half-lives (whichever is longer), prior to randomization, and&#xD;
             throughout the study, except dietary supplements or vitamins.&#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>Byung Jhip Ha</last_name>
    <role>Study Director</role>
    <affiliation>Sam Chun Dang Pharm. Co. Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Campbell</city>
        <state>California</state>
        <zip>95008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Coral Springs</city>
        <state>Florida</state>
        <zip>33067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Stuart</city>
        <state>Florida</state>
        <zip>34994</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Winter Haven</city>
        <state>Florida</state>
        <zip>33880</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Lemont</city>
        <state>Illinois</state>
        <zip>60439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Liverpool</city>
        <state>New York</state>
        <zip>13088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Springfield</city>
        <state>Oregon</state>
        <zip>97477</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Abilene</city>
        <state>Texas</state>
        <zip>79606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77384</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Willow Park</city>
        <state>Texas</state>
        <zip>76087</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Castle Hill</city>
        <state>New South Wales</state>
        <zip>2154</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Liverpool</city>
        <state>New South Wales</state>
        <zip>2170</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>East Melbourne</city>
        <state>Victoria</state>
        <zip>3002</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Sofia</city>
        <state>Sofia-Grad</state>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Sofia</city>
        <state>Sofia-Grad</state>
        <zip>1784</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Sofia</city>
        <zip>1618</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Varna</city>
        <zip>9002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Pardubice</city>
        <state>Pardubicky Kraj</state>
        <zip>530 02</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Praha</city>
        <zip>128 08</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1062</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1085</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1133</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1204</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Nyíregyháza</city>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Pécs</city>
        <zip>7621</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Wardha</city>
        <state>Maharashtra</state>
        <zip>442001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Bhubaneswar</city>
        <state>Orissa</state>
        <zip>751024</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302015</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Lucknow</city>
        <state>Uttar Pradesh</state>
        <zip>226001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700020</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700073</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Haifa</city>
        <zip>31048</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Haifa</city>
        <zip>34362</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>H̱olon</city>
        <zip>58100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Kfar Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Nahariya</city>
        <zip>22100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Petach Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Petah tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Reẖovot</city>
        <zip>76100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Tiberias</city>
        <zip>15208</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCD Research Site</name>
      <address>
        <city>Zerifin</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
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  <keyword>AMD</keyword>
  <keyword>Neovascular</keyword>
  <keyword>Exudative</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 1, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04480463
org study id: SCD411-CP101
nct id: NCT04480463
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Age-related macular degeneration (AMD) is a leading cause of vision loss in adults. Abnormal
      blood vessels grow under the macula at the back of the eye, and also leak blood and fluid,
      which damages and scars the macula, affecting vision. The current standard of care for
      patients with neovascular (exudative / wet) AMD is anti-vascular endothelial growth factor
      (anti-VEGF) therapy, which prevents or slows down the growth of the abnormal blood vessels.
      SCD411 is being developed as a biosimilar to the reference product Eylea® (aflibercept), an
      anti-VEGF drug. The study aims to prove equivalence of SCD411 to Eylea in adults with wet
      AMD, and will look at safety, tolerance, effectiveness, immune response and the movement of
      the drug through the body.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Only the unmasked investigator involved in performing the IVT injections will be unmasked to study treatment. These individuals are not allowed to discuss treatment and/or subject outcome with masked study staff, including the evaluating investigator.
measure: Change from baseline in BCVA (best corrected visual acuity)
time frame: Baseline to Week 8
description: Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts
measure: Change from baseline in BCVA (best corrected visual acuity)
time frame: Baseline to Week 52
description: Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts
measure: Percentage of subjects with anti-SCD411 antibodies
time frame: Baseline, Weeks 4, 8, 20, 36 and 52
description: Assessed by blood samples
arm group label: SCD411
arm group type: Experimental
arm group label: Aflibercept
arm group type: Active Comparator
intervention type: Drug
intervention name: SCD411
description: IVT (intravitreal) injection
arm group label: SCD411
intervention type: Drug
intervention name: Aflibercept
description: IVT injection
arm group label: Aflibercept
other name: Eylea®
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Byung Jhip Ha
role: Study Director
affiliation: Sam Chun Dang Pharm. Co. Ltd.
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country: Australia
country: Bulgaria
country: Czechia
country: Hungary
country: India
country: Israel
country: Japan
country: Korea, Republic of
country: Latvia
country: Poland
country: Russian Federation
country: Slovakia
country: Spain
country: United States
url: http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
url: http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
description: FDA Recalls, Market Withdrawals, and Safety Alerts
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Wet Macular Degeneration
mesh term: Aflibercept
sharing ipd: No
submitted: September 1, 2023