<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/NCT03805100</url>
  </required_header>
  <id_info>
    <org_study_id>XBR1001</org_study_id>
    <nct_id>NCT03805100</nct_id>
  </id_info>
  <brief_title>Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD</brief_title>
  <acronym>XPLORE</acronym>
  <official_title>A Phase III Double-Blind, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of Xlucane Versus Lucentis® in Patients With Neovascular Age-Related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xbrane Biopharma AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stada Arzneimittel AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Xbrane Biopharma AB</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>
      The objectives of the study are to demonstrate the equivalence of Xlucane to Lucentis® in&#xD;
      treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase III multicenter, double-masked, randomized, parallel group study in subjects&#xD;
      with wAMD. Approximately 580 subjects will be enrolled and randomized in a 1:1 ratio to&#xD;
      receive either Lucentis® or the investigational product, Xlucane in the study eye once every&#xD;
      4 weeks for 52 weeks. The study eye will be defined as the eye meeting the enrollment&#xD;
      criteria. The assigned study drug will be administered as an ophthalmic intravitreal (IVT)&#xD;
      injection. A subgroup of 60 subjects at a select number of participating sites will be&#xD;
      sequentially asked to participate in an evaluation of PK.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 19, 2019</start_date>
  <completion_date type="Actual">November 11, 2021</completion_date>
  <primary_completion_date type="Actual">May 11, 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Best Corrected Visual Acuity (BCVA)</measure>
    <time_frame>Week 8</time_frame>
    <description>Change(s) in BCVA letters at Week 8 compared to baseline using the ETDRS protocol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Best Corrected Visual Acuity (BCVA)</measure>
    <time_frame>Week 4, 12, 16, 24, 36 and 52</time_frame>
    <description>Change in BCVA using the ETDRS protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total size of choroidal neovascular leakage area</measure>
    <time_frame>Week 24 and 52</time_frame>
    <description>Change in total size of choroidal neovascular leakage area measured by fluorescein angiography (FA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total size of choroidal neovascularization</measure>
    <time_frame>Week 24 and 52</time_frame>
    <description>Change in total size of choroidal neovascularization measured by FA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Central Foveal Thickness (CFT)</measure>
    <time_frame>Week 2, 4, 8, 16, 24, 36 and 52</time_frame>
    <description>Change in Central Foveal Thickness (CFT) measured by OCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with loss of &lt; 15 letters</measure>
    <time_frame>Week 4, 8, 24 and 52</time_frame>
    <description>Percentage of subjects with loss of &lt; 15 letters using ETDRS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with a gain of ≥ 15 letters</measure>
    <time_frame>Week 4, 8, 24 and 52</time_frame>
    <description>Percentage of subjects with a gain of ≥ 15 letters using ETDRS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra- or subretinal fluid</measure>
    <time_frame>Week 24 and 52</time_frame>
    <description>Number of subjects without intra- or subretinal fluid (ie, completely dry)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinal pigment epithelium detachments</measure>
    <time_frame>Through study completion</time_frame>
    <description>Number of subjects with retinal pigment epithelium detachments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic Ranibizumab concentrations</measure>
    <time_frame>Day 0, Day 1 and week 20</time_frame>
    <description>Systemic Ranibizumab concentrations</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">582</enrollment>
  <condition>Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Xlucane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Xlucane (0.05 mL of 10 mg/mL ranibizumab) in the study eye monthly for 52 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lucentis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lucentis (0.05 mL of 10 mg/mL ranibizumab) in the study eye monthly for 52 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ranibizumab</intervention_name>
    <description>Intravitreal injection</description>
    <arm_group_label>Lucentis</arm_group_label>
    <arm_group_label>Xlucane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written and signed informed consent form obtained at screening, before any&#xD;
             study-related procedures.&#xD;
&#xD;
          -  Willingness and ability to undertake all scheduled visits and assessments as judged by&#xD;
             the investigator.&#xD;
&#xD;
          -  Newly diagnosed, active subfoveal Choroidal Neovascularization (CNV) lesion secondary&#xD;
             to age-related macular degeneration (AMD) in the study eye. Note: Active CNV indicates&#xD;
             the presence of leakage as evidenced by Fluorescein Angiography (FA) and intra- or&#xD;
             subretinal fluid as evidenced by Optical Coherence Tomography (OCT) which must be&#xD;
             confirmed by the central reading center during Screening:&#xD;
&#xD;
               1. The area of CNV must be ≥ 50% of the total lesion area in the study eye, and&#xD;
&#xD;
               2. Total lesion area ≤ 9.0 Disc Areas (DA) in size (including blood, scars and&#xD;
                  neovascularization) as assessed by FA in the study eye.&#xD;
&#xD;
          -  Best Corrected Visual Acuity (BCVA) of ≤ 73 and ≥ 49 ETDRS letter score in the study&#xD;
             eye, using ETDRS chart (20/40 to 20/100 Snellen equivalent) at Screening.&#xD;
&#xD;
          -  Fellow eye should not be expected to need any anti-VEGF treatment for the duration of&#xD;
             study participation.&#xD;
&#xD;
          -  Age ≥ 50 years at screening.&#xD;
&#xD;
          -  Male and female subjects of childbearing potential must be willing to completely&#xD;
             abstain or agree to use an appropriate method of contraception, from the time of&#xD;
             signing informed consent and for the duration of study participation through 3 months,&#xD;
             following the last dose of study drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any previous intervention including pharmacological treatment, laser and/or surgery&#xD;
             for wAMD in either eye; (Exception: Vitamin supplementation for AMD prevention).&#xD;
&#xD;
          -  Any previous vitreoretinal surgery in the study eye for any cause.&#xD;
&#xD;
          -  Any previous IVT treatment including any anti-VEGF medications, steroids and/or any&#xD;
             other investigational medication in either eye.&#xD;
&#xD;
          -  The use of long-acting steroids, either systemic or intraocular in any eye, in the 18&#xD;
             months before planned initiation of study treatment. (Note: Iluvien® [fluocinolone&#xD;
             acetonide intravitreal], current or planned implantation during the study, is&#xD;
             prohibited.)&#xD;
&#xD;
          -  Subfoveal fibrosis, atrophy or scarring extending &gt; 50% of total lesion area, in the&#xD;
             study eye as assessed by the investigator at screening and confirmed by the central&#xD;
             reading center prior to randomization.&#xD;
&#xD;
          -  Choroidal neovascularization in either eye due to non-AMD causes (eg, DME, RVO, ocular&#xD;
             histoplasmosis or trauma, etc.) as assessed by FA and confirmed by central reading&#xD;
             center.&#xD;
&#xD;
          -  Active or recent (within 28 days prior to randomization) intraocular, extraocular, and&#xD;
             periocular inflammation or infection in either eye.&#xD;
&#xD;
          -  History of idiopathic or autoimmune-associated uveitis in either eye.&#xD;
&#xD;
          -  Infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye.&#xD;
&#xD;
          -  Unmedicated intraocular pressure (IOP) ≥ 30 mmHg at Screening in either eye.&#xD;
&#xD;
          -  Topical ocular corticosteroids administered for ≥ 30 consecutive days in the study eye&#xD;
             within 90 days prior to Screening.&#xD;
&#xD;
          -  Spherical equivalent of the refractive error in the study eye demonstrating more than&#xD;
             8 diopters of myopia.&#xD;
&#xD;
          -  Corneal transplant or corneal dystrophy in the study eye.&#xD;
&#xD;
          -  History of rhegmatogenous retinal detachment in the study eye.&#xD;
&#xD;
          -  History of macular hole in the study eye.&#xD;
&#xD;
          -  Retinal pigment epithelial tear or rip, involving the macula in the study eye as&#xD;
             assessed by FA and confirmed by the central reading center.&#xD;
&#xD;
          -  Current vitreous hemorrhage in the study eye.&#xD;
&#xD;
          -  Subretinal hemorrhage that is ≥ 50% of the total lesion area in the study eye, or if&#xD;
             the subretinal hemorrhage involves the fovea is 1 or more DA (≥ 2.54 mm2) in size in&#xD;
             the study eye, as assessed by FA and confirmed by the central reading center.&#xD;
&#xD;
          -  Other intraocular surgery (including cataract surgery) in the study eye within the 3&#xD;
             months prior to baseline. The yttrium aluminum garnet [YAG] posterior capsulotomy is&#xD;
             allowed not later than 4 weeks prior to screening.&#xD;
&#xD;
          -  Any concurrent intraocular condition in the study eye (eg, cataract or diabetic&#xD;
             retinopathy) that, in the opinion of the investigator, could require treatment during&#xD;
             the study period to prevent or treat loss of visual acuity.&#xD;
&#xD;
          -  Significant media opacities (including cataract) in the study eye interfering with&#xD;
             BCVA assessment or fundus imaging (FA/FP/OCT).&#xD;
&#xD;
          -  Aphakia or absence of the posterior capsule in the study eye, unless it occurred as a&#xD;
             result of a YAG posterior capsulotomy in association with prior posterior chamber&#xD;
             intraocular lens implantation.&#xD;
&#xD;
          -  Presence of advanced glaucoma or optic neuropathy that involve(s) or threaten(s) the&#xD;
             central visual field in the study eye (as judged by the investigator).&#xD;
&#xD;
          -  History of glaucoma filtering surgery or argon laser trabeculoplasty in the study eye&#xD;
             (Exception: Laser iridotomy and selective laser trabeculoplasty are allowed).&#xD;
&#xD;
          -  Uncontrolled ocular glaucoma or hypertension in the study eye, defined as IOP ≥ 25&#xD;
             mmHg despite treatment with anti-glaucoma medication.&#xD;
&#xD;
          -  Any previous systemic anti-VEGF treatment (eg, bevacizumab).&#xD;
&#xD;
          -  Contraindication for Lucentis® (hypersensitivity to ranibizumab or to any of the study&#xD;
             treatment excipients).&#xD;
&#xD;
          -  Current treatment for active systemic infection.&#xD;
&#xD;
          -  Females who are pregnant, nursing, planning a pregnancy during the study, or of&#xD;
             childbearing potential and not using a reliable method of contraception and/or not&#xD;
             willing to use a reliable method of contraception during their participation in the&#xD;
             study.&#xD;
&#xD;
          -  Participation in another clinical trial within the previous 3 months or any other&#xD;
             clinical trial of anti-angiogenic drugs.&#xD;
&#xD;
          -  Reasonable suspicion of other disease or condition that might render the subject at a&#xD;
             high risk of treatment complications or otherwise confound interpretation of the study&#xD;
             results (as judged by the investigator).&#xD;
&#xD;
          -  PK subgroup only: Contraindication for additional blood sampling (as judged by the&#xD;
             investigator).&#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>Anat Loewenstein, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel-Aviv Sourasky Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Retinal Research Institute, LLC</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85296</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Retina and Vitreous Consultants</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85021-8880</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Centers P.C</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704-5611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Win Retina</name>
      <address>
        <city>Arcadia</city>
        <state>California</state>
        <zip>91006-3607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Retina Partners</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436-2018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mark B. Kislinger MD Inc.</name>
      <address>
        <city>Glendora</city>
        <state>California</state>
        <zip>91741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants Medical Group Inc.</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Retina Associates</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401-5069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fort Lauderdale Eye Institute</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33324-3118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Retina Institute</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239-7246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Retina and Macular Disease</name>
      <address>
        <city>Winter Haven</city>
        <state>Florida</state>
        <zip>33880-3919</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Retina Center</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30909-6440</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Retina</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gailey Eye Clinic</name>
      <address>
        <city>Bloomington</city>
        <state>Illinois</state>
        <zip>61704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sabates Eye Centers</name>
      <address>
        <city>Leawood</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Vitreous Surgeons of Central New York PC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>13224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Associates of Western New York</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620-4655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston Neuroscience Institute</name>
      <address>
        <city>Ladson</city>
        <state>South Carolina</state>
        <zip>29456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Black Hills Regional Eye Institute</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Research Institute of Texas</name>
      <address>
        <city>Abilene</city>
        <state>Texas</state>
        <zip>79606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Retina Associates</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705-1169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Eye Associates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77025-1756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-2727</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Ophthalmology Associates</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240-1502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Houston</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77384</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strategic Clinical Research Group LLC</name>
      <address>
        <city>Willow Park</city>
        <state>Texas</state>
        <zip>76087</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialized Eye hospital for active treatment Luxor</name>
      <address>
        <city>Plovdiv</city>
        <zip>4000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialized eye clinic Zrenie</name>
      <address>
        <city>Sofia</city>
        <zip>1408</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialized Eye hospital for active treatment Acad. Pashev</name>
      <address>
        <city>Sofia</city>
        <zip>1517</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialized Hospital for Active Treatment of Eye Diseases &quot;Zora&quot;</name>
      <address>
        <city>Sofia</city>
        <zip>1744</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMCSMP Eye Clinic St. Petka</name>
      <address>
        <city>Varna</city>
        <zip>9010</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Všeobecná FN v Praze</name>
      <address>
        <city>Brno</city>
        <zip>625 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oční klinika, Fakultní nemocnice</name>
      <address>
        <city>Hradec Králové</city>
        <zip>50005</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculty Hospital Kralovske Vinohrady</name>
      <address>
        <city>Praha</city>
        <zip>10034</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VFN Ocni klinika</name>
      <address>
        <city>Praha</city>
        <zip>12808</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Axon-Clinical, s.r.o.</name>
      <address>
        <city>Praha</city>
        <zip>15000</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mustame Eye Centre</name>
      <address>
        <city>Tallinn</city>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OÜ Dr Kai Noor Silmakabinet</name>
      <address>
        <city>Tallin</city>
        <zip>11412</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magyar Honvédség Egészségügyi Központ</name>
      <address>
        <city>Budapest</city>
        <zip>1062</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Ophthalmology, Semmelweis University</name>
      <address>
        <city>Budapest</city>
        <zip>1085</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bajcsy-Zsilinszky Hospital</name>
      <address>
        <city>Budapest</city>
        <zip>1106</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szent Imre Teaching Hospital</name>
      <address>
        <city>Budapest</city>
        <zip>1115</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Budapest Retina Associates</name>
      <address>
        <city>Budapest</city>
        <zip>1133</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jahn Ferenc South-Budapest Hospital</name>
      <address>
        <city>Budapest</city>
        <zip>1204</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Debrecen</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szabolcs-Szatmr-Bereg County Hospital</name>
      <address>
        <city>Nyíregyháza</city>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ganglion Medical Center</name>
      <address>
        <city>Pécs</city>
        <zip>7621</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Markusovszky University Teaching Hospital</name>
      <address>
        <city>Szombathely</city>
        <zip>9700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zalan Megyei Szent Rafael kórház</name>
      <address>
        <city>Zalaegerszeg</city>
        <zip>8900</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rising Retina Clinic</name>
      <address>
        <city>Ahmedabad</city>
        <zip>380015</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka University Medical Center</name>
      <address>
        <city>Beer Sheva</city>
        <zip>84101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bnai Zion Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>31048</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carmel Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>3436212</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah University Hospital</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaplan Medical Center</name>
      <address>
        <city>Reẖovot</city>
        <zip>7610001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Tel Aviv Sourasky Medical Centre</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asaf Harofe Hospital</name>
      <address>
        <city>Zrifin</city>
        <zip>73000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P.Stradins University Hospital</name>
      <address>
        <city>Riga</city>
        <zip>1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Dr Solomatin Eye Center</name>
      <address>
        <city>Riga</city>
        <zip>1050</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Lithuanian University of Health Sciences Kauno klinikos</name>
      <address>
        <city>Kaunas</city>
        <zip>50161</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vilnius University Hospital Santaros Klinikos</name>
      <address>
        <city>Vilnius</city>
        <zip>08661</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Okulistyczna Oftalmika</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85631</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Professor K. Gibinski University Clinical Centre</name>
      <address>
        <city>Katowice</city>
        <zip>40514</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie</name>
      <address>
        <city>Lublin</city>
        <zip>20079</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Diagnostyki i Mikrochirurgii Oka LENS</name>
      <address>
        <city>Olsztyn</city>
        <zip>10424</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Nowosielska Okulistyka i Chirurgia Oka</name>
      <address>
        <city>Warszawa</city>
        <zip>01249</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Okulistyka Sp. z o.o. sp. km</name>
      <address>
        <city>Warszawa</city>
        <zip>01364</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Retina</name>
      <address>
        <city>Bucharest</city>
        <zip>014142</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Opticlass Timisoara</name>
      <address>
        <city>Timişoara</city>
        <zip>300012</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FGAU NMRC MNTK Eye Microsurgery n.a. acad. S.N. Fyodorov Cheboksary Branch</name>
      <address>
        <city>Cheboksary</city>
        <zip>428028</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Kuzlyar</name>
      <address>
        <city>Kazan</city>
        <zip>420066</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budget Scientific Institute of Eye Diseases</name>
      <address>
        <city>Moscow</city>
        <zip>119021</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S. Fyodorov Eye Microsurgery Federal State Institution</name>
      <address>
        <city>Moscow</city>
        <zip>127486</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.Fyodorov Eye Microsurgery Federal State Institution</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>192283</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Pavlov State Medical University of St.Petersburg</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>F.D.Roosevelt Hospital</name>
      <address>
        <city>Banská Bystrica</city>
        <zip>97517</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univerzitna nemocnica Bratislava, Nemocnica Ruzinov</name>
      <address>
        <city>Bratislava</city>
        <zip>82606</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultna nemocnica Trencin</name>
      <address>
        <city>Trenčín</city>
        <zip>91171</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultna nemocnica s poliklinikou Zilina</name>
      <address>
        <city>Žilina</city>
        <zip>1207</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Albacete</name>
      <address>
        <city>Albacete</city>
        <zip>2006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Microcirugia Ocular</name>
      <address>
        <city>Barcelona</city>
        <zip>8035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Viladecans</name>
      <address>
        <city>Barcelona</city>
        <zip>8840</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bellvitge University Hospital</name>
      <address>
        <city>L'Hospitalet De Llobregat</city>
        <zip>8907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro-Majadahonda</name>
      <address>
        <city>Madrid</city>
        <zip>02008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad de Navarr</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Catalunya</name>
      <address>
        <city>Sant Cugat Del Vallès</city>
        <zip>08195</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unit of Macula. Oftalvist Clinic</name>
      <address>
        <city>Valencia</city>
        <zip>46004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FISABIO-Oftalmologia Medica FOM</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Rio Hortega</name>
      <address>
        <city>Valladolid</city>
        <zip>47012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Lozano Blesa</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Hospital Center for Emergency Medical Care And Disaster Medicine</name>
      <address>
        <city>Kharkiv</city>
        <zip>61204</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical and Diagnostic Centre PE PMC &quot;Acinus&quot;</name>
      <address>
        <city>Kropyvnytskyi</city>
        <zip>25006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Filatov Institute of Eye Diseases Tissue Therapy</name>
      <address>
        <city>Odessa</city>
        <zip>65061</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic of Professor Serhiienko</name>
      <address>
        <city>Vinnitsa</city>
        <zip>21000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical center LTD VISUS</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69032</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Israel</country>
    <country>Latvia</country>
    <country>Lithuania</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>March 11, 2022</last_update_submitted>
  <last_update_submitted_qc>March 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ranibizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 25, 2023</submitted>
    <returned>February 17, 2023</returned>
    <submitted>February 22, 2023</submitted>
    <returned>March 21, 2023</returned>
  </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/NCT03805100
org study id: XBR1001
nct id: NCT03805100
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The objectives of the study are to demonstrate the equivalence of Xlucane to Lucentis® in
      treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).
This is a phase III multicenter, double-masked, randomized, parallel group study in subjects
      with wAMD. Approximately 580 subjects will be enrolled and randomized in a 1:1 ratio to
      receive either Lucentis® or the investigational product, Xlucane in the study eye once every
      4 weeks for 52 weeks. The study eye will be defined as the eye meeting the enrollment
      criteria. The assigned study drug will be administered as an ophthalmic intravitreal (IVT)
      injection. A subgroup of 60 subjects at a select number of participating sites will be
      sequentially asked to participate in an evaluation of PK.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in Best Corrected Visual Acuity (BCVA)
time frame: Week 8
description: Change(s) in BCVA letters at Week 8 compared to baseline using the ETDRS protocol
measure: Change in Best Corrected Visual Acuity (BCVA)
time frame: Week 4, 12, 16, 24, 36 and 52
description: Change in BCVA using the ETDRS protocol
measure: Change in total size of choroidal neovascular leakage area
time frame: Week 24 and 52
description: Change in total size of choroidal neovascular leakage area measured by fluorescein angiography (FA)
measure: Change in total size of choroidal neovascularization
time frame: Week 24 and 52
description: Change in total size of choroidal neovascularization measured by FA
measure: Change in Central Foveal Thickness (CFT)
time frame: Week 2, 4, 8, 16, 24, 36 and 52
description: Change in Central Foveal Thickness (CFT) measured by OCT
measure: Percentage of subjects with loss of < 15 letters
time frame: Week 4, 8, 24 and 52
description: Percentage of subjects with loss of < 15 letters using ETDRS
measure: Percentage of subjects with a gain of ≥ 15 letters
time frame: Week 4, 8, 24 and 52
description: Percentage of subjects with a gain of ≥ 15 letters using ETDRS
measure: Intra- or subretinal fluid
time frame: Week 24 and 52
description: Number of subjects without intra- or subretinal fluid (ie, completely dry)
measure: Retinal pigment epithelium detachments
time frame: Through study completion
description: Number of subjects with retinal pigment epithelium detachments
measure: Systemic Ranibizumab concentrations
time frame: Day 0, Day 1 and week 20
description: Systemic Ranibizumab concentrations
arm group label: Xlucane
arm group type: Experimental
description: Xlucane (0.05 mL of 10 mg/mL ranibizumab) in the study eye monthly for 52 weeks.
arm group label: Lucentis
arm group type: Active Comparator
description: Lucentis (0.05 mL of 10 mg/mL ranibizumab) in the study eye monthly for 52 weeks.
intervention type: Biological
intervention name: Ranibizumab
description: Intravitreal injection
arm group label: Lucentis
arm group label: Xlucane
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Anat Loewenstein, Professor
role: Principal Investigator
affiliation: Tel-Aviv Sourasky Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Bulgaria
country: Czechia
country: Estonia
country: Hungary
country: India
country: Israel
country: Latvia
country: Lithuania
country: Poland
country: Romania
country: Russian Federation
country: Slovakia
country: Spain
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Ranibizumab
sharing ipd: No
submitted: January 25, 2023
returned: February 17, 2023
submitted: February 22, 2023
returned: March 21, 2023