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/NCT05996822</url>
    </required_header>
    <id_info>
      <org_study_id>AP_JCD_002</org_study_id>
      <nct_id>NCT05996822</nct_id>
    </id_info>
    <brief_title>Evaluation of Macular Edema After AcF Implant's Injection, 1 Month After the Last DXM Implant</brief_title>
    <acronym>ILUV1MOIS2</acronym>
    <official_title>Evaluation of Diabetic or Uveitic Macular Edema After Injection of a Fluocinolone Acetonide (AcF) Implant 1 Month After the Last Dexamethasone (DXM) Implant: Evaluation at 3 Years</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nantes University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nantes University Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Patients with diabetic macular edema (DME) or uveitis-related macular edema who have failed&#xD;
        first-line therapy such as anti-VEGF, laser treatments, or dexamethasone implants (DXM) are&#xD;
        candidates for treatment with an intravitreal injection of a fluocinolone acetonide (AcF)&#xD;
        implant. AcF is unique in that it delivers intravitreal corticosteroids for 2 to 3 years,&#xD;
        whereas DXM only releases them for 3 to 6 months. After 6 months for AcF and 1 month for DXM,&#xD;
        full therapeutic efficacy is attained.&#xD;
  &#xD;
        AcF's safety and efficacy have now been confirmed in the FAME originator studies as well as&#xD;
        other phase IV investigations. However, in the FAME princeps trials and numerous phase IV&#xD;
        trials where patients got AcF more than 6 months after DXM, up to 40% of patients required&#xD;
        laser, anti-VEGF, and/or DXM retreatment within the AcF active period. This high rate could&#xD;
        be attributed to AcF's 6-month delay in reaching full efficacy.&#xD;
  &#xD;
        This is why the investigators intended to replicate the previous Iluvi1-month research, which&#xD;
        shown that injecting DXM at 1 month preserved visual acuity and central retinal thickness for&#xD;
        the first 6 months without increasing intraocular pressure significantly. The study, however,&#xD;
        was unable to determine the long-term impact on the rate of relapses requiring additional&#xD;
        therapy as well as tolerance with the development of long-term cortisone-induced glaucoma.&#xD;
  &#xD;
        In light of this, the investigators should like to gather new data for a 3-year follow-up&#xD;
        after AcF injection, including measurements of optic nerve fibre thickness (OCT RNFL). This&#xD;
        is an essential safety data point because it assesses the long-term effects of ocular&#xD;
        hypertension, which is a well-known side effect of intravitreal corticosteroids.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Efficiency (ETDRS)</measure>
      <time_frame>1 month after AcF injection</time_frame>
      <description>change in visual acuity by ETDRS between baseline(before AcF injection) and 1 month after</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Efficiency (OCT)</measure>
      <time_frame>1 month after AcF injection</time_frame>
      <description>change in macular thickness by OCT between baseline(before AcF injection) and 1 month after</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>safety (AE)</measure>
      <time_frame>1 month after AcF injection</time_frame>
      <description>Report of the adverse events during 1 month after ACF injection</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">34</enrollment>
    <condition>Macular Edema</condition>
    <arm_group>
      <arm_group_label>AcF injection</arm_group_label>
      <description>Patient having received an AcF injection 1 month after a DXM injection for the treatment of Diabetic Macular Edema or Uveitic Macular Edema</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ACF injection</intervention_name>
      <description>AcF injection 1 month after a DXM injection</description>
      <arm_group_label>AcF injection</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants recruited in the study extension will be the same as those in the initial&#xD;
          ILUV1MOIS study.&#xD;
  &#xD;
          The investigators will present the study extension to the patients at their scheduled&#xD;
          routine care visits.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient (Male, Female)°≥ 18 years old&#xD;
  &#xD;
            -  Having received an AcF injection 1 month after a DXM injection&#xD;
  &#xD;
            -  For diabetic macular edema or uveitic macular edema&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient's refusal to allow his or her medical data to be used for research purposes&#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>Jean-Baptiste Ducloyer, M.D</last_name>
      <phone>0253482857</phone>
      <email>jeanbaptiste.ducloyer@chu-nantes.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alexandra Poinas</last_name>
      <phone>0253482857</phone>
      <email>alexandra.poinas@chu-nantes.fr</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</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 Edema</mesh_term>
      <mesh_term>Edema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05996822
  org study id: AP_JCD_002
  nct id: NCT05996822
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients with diabetic macular edema (DME) or uveitis-related macular edema who have failed
        first-line therapy such as anti-VEGF, laser treatments, or dexamethasone implants (DXM) are
        candidates for treatment with an intravitreal injection of a fluocinolone acetonide (AcF)
        implant. AcF is unique in that it delivers intravitreal corticosteroids for 2 to 3 years,
        whereas DXM only releases them for 3 to 6 months. After 6 months for AcF and 1 month for DXM,
        full therapeutic efficacy is attained.
  
        AcF's safety and efficacy have now been confirmed in the FAME originator studies as well as
        other phase IV investigations. However, in the FAME princeps trials and numerous phase IV
        trials where patients got AcF more than 6 months after DXM, up to 40% of patients required
        laser, anti-VEGF, and/or DXM retreatment within the AcF active period. This high rate could
        be attributed to AcF's 6-month delay in reaching full efficacy.
  
        This is why the investigators intended to replicate the previous Iluvi1-month research, which
        shown that injecting DXM at 1 month preserved visual acuity and central retinal thickness for
        the first 6 months without increasing intraocular pressure significantly. The study, however,
        was unable to determine the long-term impact on the rate of relapses requiring additional
        therapy as well as tolerance with the development of long-term cortisone-induced glaucoma.
  
        In light of this, the investigators should like to gather new data for a 3-year follow-up
        after AcF injection, including measurements of optic nerve fibre thickness (OCT RNFL). This
        is an essential safety data point because it assesses the long-term effects of ocular
        hypertension, which is a well-known side effect of intravitreal corticosteroids.
  observational model: Cohort
  time perspective: Retrospective
  measure: Efficiency (ETDRS)
  time frame: 1 month after AcF injection
  description: change in visual acuity by ETDRS between baseline(before AcF injection) and 1 month after
  measure: Efficiency (OCT)
  time frame: 1 month after AcF injection
  description: change in macular thickness by OCT between baseline(before AcF injection) and 1 month after
  measure: safety (AE)
  time frame: 1 month after AcF injection
  description: Report of the adverse events during 1 month after ACF injection
  arm group label: AcF injection
  description: Patient having received an AcF injection 1 month after a DXM injection for the treatment of Diabetic Macular Edema or Uveitic Macular Edema
  intervention type: Drug
  intervention name: ACF injection
  description: AcF injection 1 month after a DXM injection
  arm group label: AcF injection
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jean-Baptiste Ducloyer, M.D
  phone: 0253482857
  email: jeanbaptiste.ducloyer@chu-nantes.fr
  last name: Alexandra Poinas
  phone: 0253482857
  email: alexandra.poinas@chu-nantes.fr
  responsible party type: Sponsor
  mesh term: Macular Edema
  mesh term: Edema
  sharing ipd: Undecided