<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/NCT04482543</url>
  </required_header>
  <id_info>
    <org_study_id>23454</org_study_id>
    <nct_id>NCT04482543</nct_id>
  </id_info>
  <brief_title>Repeated Methotrexate for Proliferative Vitreoretinopathy Grade C</brief_title>
  <official_title>Repeated Intra-silicone Oil Injection of Methotrexate for Management of Proliferative Vitreoretinopathy Grade C; A Multi-center Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shahid Beheshti University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shahid Beheshti University of Medical Sciences</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>
      This multicenter randomized clinical trial evaluates the effect of multiple intra-silicone&#xD;
      oil injections of methotrexate (MTX) on rhegmatogenous retinal detachment (RRD) with grade C&#xD;
      proliferative vitreoretinopathy (PVR).&#xD;
&#xD;
      74 eyes with the diagnosis of RRD with PVR grade C will be randomized into two groups: the&#xD;
      intervention group and the control group. All eyes undergo pars plana vitrectomy(PPV) and&#xD;
      intraocular injection of silicone oil (SO). At the end of the surgical procedure, intra-SO&#xD;
      injection of 250 µg MTX will be performed in the intervention group. No intra-SO injection&#xD;
      will be done in the control group. In the intervention group, Intra-SO injection of MTX will&#xD;
      be repeated at 3 and 6 weeks postoperatively. Silicone oil removal will be done 3 months&#xD;
      after surgery.Spectral-domain optical coherence tomography (SD-OCT) image of the macula will&#xD;
      be acquired at months 3 and 6. The retinal reattachment rate at months 6 will be assessed as&#xD;
      the main outcome measure of the study. Best corrected visual acuity, retinal reproliferation&#xD;
      rate and adverse events are the secondary outcome measures. Comprehensive ocular examination&#xD;
      will be performed at weeks 1, 3, 6 and at months 3, 4 and 6.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</primary_completion_date>
  <phase>Phase 2/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 (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retinal reattachment rate</measure>
    <time_frame>6 months</time_frame>
    <description>Funduscopy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best corrected visual acuity</measure>
    <time_frame>6 months</time_frame>
    <description>Snellen chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinal reproliferation rate</measure>
    <time_frame>6 months</time_frame>
    <description>Funduscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>6 months</time_frame>
    <description>Slit-lamp, tonometry and funduscopy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Proliferative Vitreoretinopathy</condition>
  <arm_group>
    <arm_group_label>Intra-silicone oil injection of 250 µg methotrexate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No intra-silicone oil injection of methotrexate</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methotrexate</intervention_name>
    <description>Intra-silicone oil injection of 250 µg methotrexate is done at the end of surgery and is repeated at weeks 3 and 6 postoperatively.</description>
    <arm_group_label>Intra-silicone oil injection of 250 µg methotrexate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Rhegmatogenous retinal detachment with proliferative vitreoretinopathy grade C&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age of under 18 years old&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Glaucoma&#xD;
&#xD;
          -  Macular disorders&#xD;
&#xD;
          -  Diabetic retinopathy&#xD;
&#xD;
          -  Retinal vascular occlusion&#xD;
&#xD;
          -  History of penetrating ocular trauma&#xD;
&#xD;
          -  Giant retinal tear&#xD;
&#xD;
          -  Chronic uveitis&#xD;
&#xD;
          -  History of intraocular steroid injection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hamid Ahmadieh, MD</last_name>
    <phone>+98 9122195871</phone>
    <email>hahmadieh@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ophthalmic Research Center</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hamid Ahmadieh, MD</last_name>
      <phone>+98 9122195871</phone>
      <email>hahmadieh@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 18, 2020</last_update_submitted>
  <last_update_submitted_qc>July 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Beheshti University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Zahra Rabbani Khah</investigator_full_name>
    <investigator_title>Head of ophthalmic research center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitreoretinopathy, Proliferative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methotrexate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04482543
org study id: 23454
nct id: NCT04482543
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This multicenter randomized clinical trial evaluates the effect of multiple intra-silicone
      oil injections of methotrexate (MTX) on rhegmatogenous retinal detachment (RRD) with grade C
      proliferative vitreoretinopathy (PVR).

      74 eyes with the diagnosis of RRD with PVR grade C will be randomized into two groups: the
      intervention group and the control group. All eyes undergo pars plana vitrectomy(PPV) and
      intraocular injection of silicone oil (SO). At the end of the surgical procedure, intra-SO
      injection of 250 µg MTX will be performed in the intervention group. No intra-SO injection
      will be done in the control group. In the intervention group, Intra-SO injection of MTX will
      be repeated at 3 and 6 weeks postoperatively. Silicone oil removal will be done 3 months
      after surgery.Spectral-domain optical coherence tomography (SD-OCT) image of the macula will
      be acquired at months 3 and 6. The retinal reattachment rate at months 6 will be assessed as
      the main outcome measure of the study. Best corrected visual acuity, retinal reproliferation
      rate and adverse events are the secondary outcome measures. Comprehensive ocular examination
      will be performed at weeks 1, 3, 6 and at months 3, 4 and 6.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Retinal reattachment rate
time frame: 6 months
description: Funduscopy
measure: Best corrected visual acuity
time frame: 6 months
description: Snellen chart
measure: Retinal reproliferation rate
time frame: 6 months
description: Funduscopy
measure: Adverse events
time frame: 6 months
description: Slit-lamp, tonometry and funduscopy
arm group label: Intra-silicone oil injection of 250 µg methotrexate
arm group type: Active Comparator
arm group label: No intra-silicone oil injection of methotrexate
arm group type: No Intervention
intervention type: Drug
intervention name: Methotrexate
description: Intra-silicone oil injection of 250 µg methotrexate is done at the end of surgery and is repeated at weeks 3 and 6 postoperatively.
arm group label: Intra-silicone oil injection of 250 µg methotrexate
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hamid Ahmadieh, MD
phone: +98 9122195871
email: hahmadieh@hotmail.com
facility: 
status: Recruiting
contact: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Shahid Beheshti University of Medical Sciences
investigator full name: Zahra Rabbani Khah
investigator title: Head of ophthalmic research center
mesh term: Vitreoretinopathy, Proliferative
mesh term: Methotrexate