xml: <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/NCT05990829</url>
    </required_header>
    <id_info>
      <org_study_id>TianjinMUEHhbj001</org_study_id>
      <nct_id>NCT05990829</nct_id>
    </id_info>
    <brief_title>Compare the Efficacy of VItrectomy Combined With DExamethasone Implant Versus With Aflibercept in DME Patients Diagnosed by Intraoperative OCT (the VIDEO Study): Study Protocol for a Randomized Controlled Trial</brief_title>
    <official_title>Compare the Efficacy of VItrectomy Combined With DExamethasone Implant Versus With Aflibercept in DME Patients Diagnosed by Intraoperative OCT (the VIDEO Study): Study Protocol for a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tianjin Medical University Eye Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Abbvie Pharmaceutical Trading (Shanghai) Co., Ltd.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Tianjin Medical University Eye Hospital</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>
        Diabetic macular edema (DME) is the main cause of severe vision loss in diabetic retinopathy.&#xD;
        Intravitreal injection of anti-vascular endothelial growth factor (VEGF) and Ozurdex are two&#xD;
        safe and effective ways to treat DME. Pars plana vitrectomy is mainly suitable for the&#xD;
        treatment of unabsorbed vitreous hemorrhage (VH) and tractional retinal detachment caused by&#xD;
        proliferative diabetic retinopathy (PDR). Intraoperative optical coherence tomography (OCT),&#xD;
        a diagnostic device, can be used to evaluate the potential condition of the retina. Many&#xD;
        patients with PDR have unclear refractive stroma due to VH and other reasons, so preoperative&#xD;
        OCT cannot give a clear diagnosis, so the use of intraoperative OCT can judge whether the&#xD;
        patients are complicated with DME and give corresponding treatment. The purpose of this study&#xD;
        is to explore the prognosis of patients with DME diagnosed by OCT during PPV and treated with&#xD;
        PPV combined with aflibercept or PPV combined with Ozurdex, and to observe and compare the&#xD;
        postoperative anatomical results, functional results, times of reinjections and the&#xD;
        occurrence of adverse events between the two groups, in order to provide accurate treatment&#xD;
        for patients, reduce the frequency of postoperative vitreous injection and lighten the burden&#xD;
        of patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Average change in central foveal thickness (CFT)</measure>
      <time_frame>1, 3, 6 month postoperatively</time_frame>
      <description>Three-dimensional swept source optical coherence tomography (SS-OCT)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Average change in best corrected visual acuity (BCVA)</measure>
      <time_frame>1, 3, 6 month postoperatively</time_frame>
      <description>Early Treatment Diabetic Retinopathy Study (ETDRS) Alphabet Chart</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of reinjections</measure>
      <time_frame>6 months postoperatively</time_frame>
      <description>Each participant will receive pro re nata therapy, with regular monitoring for 6 months, at least 3 months apart for the study group and 1 month apart for the control group. Further treatment will be performed if the following criteria are met: (1) existence of recent or persisting cystoid retinal lesions; (2) a decrease of no less than 5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in BCVA; and (3) an increase of 50 m or more in central foveal thickness (CFT) compared with the best value previously achieved.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">64</enrollment>
    <condition>Diabetic Macular Edema</condition>
    <condition>Pars Plana Vitrectomy</condition>
    <condition>Dexamethasone Intravitreal Implant</condition>
    <condition>Intraoperative Optical Coherence Tomography</condition>
    <arm_group>
      <arm_group_label>Ozurdex group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of Ozurdex will be performed at the end of the surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Aflibercept group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of aflibercept will be performed at the end of the surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ozurdex</intervention_name>
      <description>Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation (PRP) should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of Ozurdex will be performed at the end of the surgery.</description>
      <arm_group_label>Ozurdex group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Aflibercept</intervention_name>
      <description>Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation (PRP) should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of aflibercept will be performed at the end of the surgery.</description>
      <arm_group_label>Aflibercept group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥18 years of age;&#xD;
  &#xD;
            -  Patients and their families fully understand the research and must sign an informed&#xD;
               consent form;&#xD;
  &#xD;
            -  Patients have a history of diabetes and were diagnosed with PDR by ophthalmic&#xD;
               examination;&#xD;
  &#xD;
            -  Haemoglobin A1c (HbA1c) levels of &lt;10% within 3 months;&#xD;
  &#xD;
            -  No contraindication of vitrectomy;&#xD;
  &#xD;
            -  Pseudophakia or this operation is combined with phacoemulsification and lens&#xD;
               implantation;&#xD;
  &#xD;
            -  Diagnosed with DME by intraoperative optical coherence tomography during vitrectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The follow-up period is less than 6 months;&#xD;
  &#xD;
            -  Patients need gas or silicon oil tamponade;&#xD;
  &#xD;
            -  Patients with rubeosis iridis, neovascular glaucoma and endophthalmitis;&#xD;
  &#xD;
            -  Patients with other intraocular surgeries (except cataract surgery with no ruptured&#xD;
               posterior lens capsule);&#xD;
  &#xD;
            -  Patients with other retinal diseases (i.e., age-related macular degeneration, retinal&#xD;
               vein occlusion);&#xD;
  &#xD;
            -  Patients received intravitreal Ozurdex three months prior to screening or anti-VEGF&#xD;
               injection one month prior to screening;&#xD;
  &#xD;
            -  Patients with uncontrolled systemic disease&#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_contact>
      <last_name>Bojie Hu</last_name>
      <email>bhu07@tmu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tianjin medical university eye hosipital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tianjin Medical University Eye Hospital</investigator_affiliation>
      <investigator_full_name>Bojie Hu</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Macular Edema</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 for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05990829
  org study id: TianjinMUEHhbj001
  nct id: NCT05990829
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Diabetic macular edema (DME) is the main cause of severe vision loss in diabetic retinopathy.
        Intravitreal injection of anti-vascular endothelial growth factor (VEGF) and Ozurdex are two
        safe and effective ways to treat DME. Pars plana vitrectomy is mainly suitable for the
        treatment of unabsorbed vitreous hemorrhage (VH) and tractional retinal detachment caused by
        proliferative diabetic retinopathy (PDR). Intraoperative optical coherence tomography (OCT),
        a diagnostic device, can be used to evaluate the potential condition of the retina. Many
        patients with PDR have unclear refractive stroma due to VH and other reasons, so preoperative
        OCT cannot give a clear diagnosis, so the use of intraoperative OCT can judge whether the
        patients are complicated with DME and give corresponding treatment. The purpose of this study
        is to explore the prognosis of patients with DME diagnosed by OCT during PPV and treated with
        PPV combined with aflibercept or PPV combined with Ozurdex, and to observe and compare the
        postoperative anatomical results, functional results, times of reinjections and the
        occurrence of adverse events between the two groups, in order to provide accurate treatment
        for patients, reduce the frequency of postoperative vitreous injection and lighten the burden
        of patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Average change in central foveal thickness (CFT)
  time frame: 1, 3, 6 month postoperatively
  description: Three-dimensional swept source optical coherence tomography (SS-OCT)
  measure: Average change in best corrected visual acuity (BCVA)
  time frame: 1, 3, 6 month postoperatively
  description: Early Treatment Diabetic Retinopathy Study (ETDRS) Alphabet Chart
  measure: Number of reinjections
  time frame: 6 months postoperatively
  description: Each participant will receive pro re nata therapy, with regular monitoring for 6 months, at least 3 months apart for the study group and 1 month apart for the control group. Further treatment will be performed if the following criteria are met: (1) existence of recent or persisting cystoid retinal lesions; (2) a decrease of no less than 5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in BCVA; and (3) an increase of 50 m or more in central foveal thickness (CFT) compared with the best value previously achieved.
  arm group label: Ozurdex group
  arm group type: Experimental
  description: Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of Ozurdex will be performed at the end of the surgery.
  arm group label: Aflibercept group
  arm group type: Active Comparator
  description: Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of aflibercept will be performed at the end of the surgery.
  intervention type: Drug
  intervention name: Ozurdex
  description: Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation (PRP) should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of Ozurdex will be performed at the end of the surgery.
  arm group label: Ozurdex group
  intervention type: Drug
  intervention name: Aflibercept
  description: Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation (PRP) should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of aflibercept will be performed at the end of the surgery.
  arm group label: Aflibercept group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bojie Hu
  email: bhu07@tmu.edu.cn
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Tianjin Medical University Eye Hospital
  investigator full name: Bojie Hu
  investigator title: Professor
  mesh term: Macular Edema
  mesh term: Aflibercept