<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/NCT04464694</url>
  </required_header>
  <id_info>
    <org_study_id>XH-20-011</org_study_id>
    <nct_id>NCT04464694</nct_id>
  </id_info>
  <brief_title>Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema</brief_title>
  <official_title>Prospective, Single-blind, Randomised, Controlled, Multi-centre Study to Evaluate the Benefit of Ranibizumab as an Adjunctive Therapy to Vitrectomy for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Oedema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate ranibizumab's benefit on prevention of early postoperative vitreous&#xD;
      haemorrhage in PDR-DME patients receiving vitrectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective: To investigate ranibizumab's benefit on prevention of early postoperative&#xD;
      vitreous haemorrhage in PDR-DME patients receiving vitrectomy.&#xD;
&#xD;
      Secondary Objective:To investigate ranibizumab's additional benefit on visual improvement,&#xD;
      facilitation of surgery and postoperative outcomes in PDR-DME patients receiving vitrectomy.&#xD;
&#xD;
      Study design: This study is a prospective, randomized, single-blinded, blank-controlled,&#xD;
      multi-center clinical trial that requires vitrectomy for PDR-DME patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Early postoperative vitreous haemorrhage</measure>
    <time_frame>From day 1 to week 4 after the vitrectomy</time_frame>
    <description>To compare the incidence of the early postoperative vitreous haemorrhage between two arms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Best-corrected visual acuity (BCVA) at Month 3</measure>
    <time_frame>Month 3 after vitrectomy</time_frame>
    <description>To compare the changes from baseline BCVA to mean BCVA at month 3 between two arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Best-corrected visual acuity (BCVA) at Month 6</measure>
    <time_frame>Month 6 after vitrectomy</time_frame>
    <description>To compare the changes from baseline BCVA to mean BCVA at month 6 between two arms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">142</enrollment>
  <condition>Proliferative Diabetic Retinopathy</condition>
  <condition>Diabetic Macular Edema</condition>
  <arm_group>
    <arm_group_label>Ranibizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intravitreal injection of ranibizumab (0.5 mg) 3~7 days before vitrectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham injection</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham injection 3~7 days before vitrectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranibizumab</intervention_name>
    <description>Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3~7 days before vitrectomy.</description>
    <arm_group_label>Ranibizumab</arm_group_label>
    <other_name>Lucentis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham injection</intervention_name>
    <description>Patients will receive single sham injection 3~7 days before vitrectomy.</description>
    <arm_group_label>Sham injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pars plana vitrectomy</intervention_name>
    <description>Surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina</description>
    <arm_group_label>Ranibizumab</arm_group_label>
    <arm_group_label>Sham injection</arm_group_label>
    <other_name>Vitrectomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age≥18 years old;&#xD;
&#xD;
          2. Type I or II diabetes mellitus, clinically diagnosed as diabetic macular edema&#xD;
&#xD;
          3. Diagnosed as proliferative diabetic retinopathy and pas plana vitrectomy (PPV) is&#xD;
             required to undergo due to non-absorbent vitreous hemorrhage (VH), fibrovascular&#xD;
             proliferation with vitreoretinal adhesions or tractional retinal detachment (TRD); or&#xD;
             active severe proliferative retinopathy not responding to previous panretinal laser&#xD;
             photocoagulation; as well as other indications of PPV at the investigator's discretion&#xD;
&#xD;
          4. Ability to provide written informed consent and comply with study assessments for the&#xD;
             full duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or lactation;&#xD;
&#xD;
          2. History of stroke, peripheral vascular disease, angina or myocardial infarction within&#xD;
             six months&#xD;
&#xD;
          3. Intraocular treatment with corticosteroids, anti-vascular endothelium growth factor or&#xD;
             intraocular surgery within 45 days preceding baseline;&#xD;
&#xD;
          4. Clinically confirmed intraocular pressure (IOP) &gt;=21 mmHg, uncontrolled glaucoma or&#xD;
             iris neovascularization in either eye&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peiquan Zhao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peiquan Zhao</last_name>
    <phone>13311620396</phone>
    <email>Zhaopeiquan@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ningbo Eye Hospital</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315012</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Quanyong Yi</last_name>
      <phone>13586543802</phone>
      <email>1067572232@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Eye &amp; Ent Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <zip>2000831</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xin Huang</last_name>
      <phone>13818902665</phone>
      <email>xinhuang66@icloud.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <zip>2000892</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Peiquan Zhao</last_name>
      <phone>+8613311620396</phone>
      <email>zhaopeiquan@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Lo WR, Kim SJ, Aaberg TM Sr, Bergstrom C, Srivastava SK, Yan J, Martin DF, Hubbard GB 3rd. Visual outcomes and incidence of recurrent vitreous hemorrhage after vitrectomy in diabetic eyes pretreated with bevacizumab (avastin). Retina. 2009 Jul-Aug;29(7):926-31. doi: 10.1097/IAE.0b013e3181a8eb88.</citation>
    <PMID>19584650</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhao LQ, Zhu H, Zhao PQ, Hu YQ. A systematic review and meta-analysis of clinical outcomes of vitrectomy with or without intravitreal bevacizumab pretreatment for severe diabetic retinopathy. Br J Ophthalmol. 2011 Sep;95(9):1216-22. doi: 10.1136/bjo.2010.189514. Epub 2011 Jan 27.</citation>
    <PMID>21278146</PMID>
  </results_reference>
  <results_reference>
    <citation>Comyn O, Wickham L, Charteris DG, Sullivan PM, Ezra E, Gregor Z, Aylward GW, da Cruz L, Fabinyi D, Peto T, Restori M, Xing W, Bunce C, Hykin PG, Bainbridge JW. Ranibizumab pretreatment in diabetic vitrectomy: a pilot randomised controlled trial (the RaDiVit study). Eye (Lond). 2017 Sep;31(9):1253-1258. doi: 10.1038/eye.2017.75. Epub 2017 May 12.</citation>
    <PMID>28498374</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PDR</keyword>
  <keyword>DME</keyword>
  <keyword>ranibizumab</keyword>
  <keyword>vitrectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Edema</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>
  <!-- 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/NCT04464694
org study id: XH-20-011
nct id: NCT04464694
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
To investigate ranibizumab's benefit on prevention of early postoperative vitreous
      haemorrhage in PDR-DME patients receiving vitrectomy.
Primary Objective: To investigate ranibizumab's benefit on prevention of early postoperative
      vitreous haemorrhage in PDR-DME patients receiving vitrectomy.

      Secondary Objective:To investigate ranibizumab's additional benefit on visual improvement,
      facilitation of surgery and postoperative outcomes in PDR-DME patients receiving vitrectomy.

      Study design: This study is a prospective, randomized, single-blinded, blank-controlled,
      multi-center clinical trial that requires vitrectomy for PDR-DME patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Early postoperative vitreous haemorrhage
time frame: From day 1 to week 4 after the vitrectomy
description: To compare the incidence of the early postoperative vitreous haemorrhage between two arms
measure: Mean Best-corrected visual acuity (BCVA) at Month 3
time frame: Month 3 after vitrectomy
description: To compare the changes from baseline BCVA to mean BCVA at month 3 between two arms.
measure: Mean Best-corrected visual acuity (BCVA) at Month 6
time frame: Month 6 after vitrectomy
description: To compare the changes from baseline BCVA to mean BCVA at month 6 between two arms.
arm group label: Ranibizumab
arm group type: Experimental
description: Single intravitreal injection of ranibizumab (0.5 mg) 3~7 days before vitrectomy
arm group label: Sham injection
arm group type: Sham Comparator
description: Sham injection 3~7 days before vitrectomy
intervention type: Drug
intervention name: Ranibizumab
description: Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3~7 days before vitrectomy.
arm group label: Ranibizumab
other name: Lucentis
intervention type: Other
intervention name: Sham injection
description: Patients will receive single sham injection 3~7 days before vitrectomy.
arm group label: Sham injection
intervention type: Procedure
intervention name: Pars plana vitrectomy
description: Surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina
arm group label: Ranibizumab
arm group label: Sham injection
other name: Vitrectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peiquan Zhao
role: Principal Investigator
affiliation: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
last name: Peiquan Zhao
phone: 13311620396
email: Zhaopeiquan@126.com
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
country: China
citation: Lo WR, Kim SJ, Aaberg TM Sr, Bergstrom C, Srivastava SK, Yan J, Martin DF, Hubbard GB 3rd. Visual outcomes and incidence of recurrent vitreous hemorrhage after vitrectomy in diabetic eyes pretreated with bevacizumab (avastin). Retina. 2009 Jul-Aug;29(7):926-31. doi: 10.1097/IAE.0b013e3181a8eb88.
PMID: 19584650
citation: Zhao LQ, Zhu H, Zhao PQ, Hu YQ. A systematic review and meta-analysis of clinical outcomes of vitrectomy with or without intravitreal bevacizumab pretreatment for severe diabetic retinopathy. Br J Ophthalmol. 2011 Sep;95(9):1216-22. doi: 10.1136/bjo.2010.189514. Epub 2011 Jan 27.
PMID: 21278146
citation: Comyn O, Wickham L, Charteris DG, Sullivan PM, Ezra E, Gregor Z, Aylward GW, da Cruz L, Fabinyi D, Peto T, Restori M, Xing W, Bunce C, Hykin PG, Bainbridge JW. Ranibizumab pretreatment in diabetic vitrectomy: a pilot randomised controlled trial (the RaDiVit study). Eye (Lond). 2017 Sep;31(9):1253-1258. doi: 10.1038/eye.2017.75. Epub 2017 May 12.
PMID: 28498374
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Edema
mesh term: Ranibizumab
sharing ipd: No