<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/NCT03010397</url>
  </required_header>
  <id_info>
    <org_study_id>IPM-2016</org_study_id>
    <nct_id>NCT03010397</nct_id>
  </id_info>
  <brief_title>Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes</brief_title>
  <acronym>PROGRESS</acronym>
  <official_title>PROGRESS - Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association for Innovation and Biomedical Research on Light and Image</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Association for Innovation and Biomedical Research on Light and Image</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Progression of Diabetic Retinopathy. Identification of Signs and Surrogate outcomes&#xD;
      (PROGRESS)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The global aim of this study is to improve the current knowledge of diabetic retinopathy (DR)&#xD;
      progression. We aim to characterize both functionally and morphologically initial DR stages&#xD;
      and to identify patients at risk of progression to centre involving macular oedema (CME)&#xD;
      and/or proliferative diabetic retinopathy (PDR). We want to identify imaging patterns and&#xD;
      characteristics that might be used as prognostic biomarkers for DR progression.&#xD;
&#xD;
      For this, ischemia and blood-retinal barrier alteration will be assessed using non-invasive&#xD;
      retinal imaging methodologies. SD-OCT with layer-by-layer segmentation will be performed.&#xD;
      Furthermore, a state-of-the-art methodology with OCT-Angiography will be used for&#xD;
      identification of areas of capillary drop-out and leakage areas will be identified on SD-OCT&#xD;
      without the need of a dye injection. In a subgroup of patients we will study&#xD;
      neurodegeneration patterns using multifocal ERG examination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">March 6, 2019</completion_date>
  <primary_completion_date type="Actual">January 11, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Phenotypic classification of DR in a 5-year period</measure>
    <time_frame>5 years</time_frame>
    <description>Presence CME (Central Macular Edema) or PDR (Proliferative Diabetic Retinopathy)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DR severity level</measure>
    <time_frame>5 years</time_frame>
    <description>ETDRS grading</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinal thickness analysis</measure>
    <time_frame>5 years</time_frame>
    <description>Retinal thickness (RT) in central subfield, inner and outer rings, assessed by SD-OCT and using layer-by-layer segmentation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ellipsoid zone analysis</measure>
    <time_frame>5 years</time_frame>
    <description>Degree of integrity of the ellipsoid zone, assessed by SD-OCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Choroidal thickness analysis</measure>
    <time_frame>5 years</time_frame>
    <description>Choroidal thickness assessed by Enhanced Depth Imaging (EDI) SD-OCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SD- OCT- Angiography analysis</measure>
    <time_frame>5 years</time_frame>
    <description>Vessel analysis, assessed by SD-OCT OCT-Angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OCT-Leakage analysis</measure>
    <time_frame>5 years</time_frame>
    <description>LOR (low optical reflectivity) ratio in central subfield, inner and outer ring for assessment of BRB breakdown, assessed by OCT-Leakage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinal thickness quantification</measure>
    <time_frame>5 years</time_frame>
    <description>Retinal nerve fiber layer thickness (RNFL) and ganglion cells layer (GCL) + inner plexiform layer thickness (IPL) thickness, assessed by layer-by-layer SD-OCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mfERG assessement</measure>
    <time_frame>5 years</time_frame>
    <description>P1 implicit time and P1 amplitude by ring</description>
  </secondary_outcome>
  <enrollment type="Anticipated">212</enrollment>
  <condition>Diabetic Retinopathy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Any patients followed under the normal clinical practice at AIBILI Clinical Trial Centre.&#xD;
&#xD;
        - Type 2 diabetes mellitus according to 1985 WHO criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes mellitus according to 1985 WHO criteria&#xD;
&#xD;
          -  Aged between 35 years and 80 at baseline in the retrospective period&#xD;
&#xD;
          -  NPDR level &lt; 20 (MA absent) or Mild NPDR (levels 20 to 35, based on ETDRS criteria- 7&#xD;
             fields CFP) at baseline&#xD;
&#xD;
          -  BCVA ≥ 75 letters (≥ 20/32) at baseline (ETDRS charts)&#xD;
&#xD;
          -  Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inadequate ocular media and/ or pupil dilatation that interfere with fundus&#xD;
             examinations&#xD;
&#xD;
          -  HbA1C &gt; 10 % at the Screening or previous 6 months in the previous prospective study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aibili-Cec</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-548</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</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>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03010397
org study id: IPM-2016
nct id: NCT03010397
lead sponsor: 
has dmc: No
Progression of Diabetic Retinopathy. Identification of Signs and Surrogate outcomes
      (PROGRESS)
The global aim of this study is to improve the current knowledge of diabetic retinopathy (DR)
      progression. We aim to characterize both functionally and morphologically initial DR stages
      and to identify patients at risk of progression to centre involving macular oedema (CME)
      and/or proliferative diabetic retinopathy (PDR). We want to identify imaging patterns and
      characteristics that might be used as prognostic biomarkers for DR progression.

      For this, ischemia and blood-retinal barrier alteration will be assessed using non-invasive
      retinal imaging methodologies. SD-OCT with layer-by-layer segmentation will be performed.
      Furthermore, a state-of-the-art methodology with OCT-Angiography will be used for
      identification of areas of capillary drop-out and leakage areas will be identified on SD-OCT
      without the need of a dye injection. In a subgroup of patients we will study
      neurodegeneration patterns using multifocal ERG examination.
observational model: Cohort
time perspective: Prospective
measure: Phenotypic classification of DR in a 5-year period
time frame: 5 years
description: Presence CME (Central Macular Edema) or PDR (Proliferative Diabetic Retinopathy)
measure: DR severity level
time frame: 5 years
description: ETDRS grading
measure: Retinal thickness analysis
time frame: 5 years
description: Retinal thickness (RT) in central subfield, inner and outer rings, assessed by SD-OCT and using layer-by-layer segmentation
measure: Ellipsoid zone analysis
time frame: 5 years
description: Degree of integrity of the ellipsoid zone, assessed by SD-OCT
measure: Choroidal thickness analysis
time frame: 5 years
description: Choroidal thickness assessed by Enhanced Depth Imaging (EDI) SD-OCT
measure: SD- OCT- Angiography analysis
time frame: 5 years
description: Vessel analysis, assessed by SD-OCT OCT-Angiography
measure: OCT-Leakage analysis
time frame: 5 years
description: LOR (low optical reflectivity) ratio in central subfield, inner and outer ring for assessment of BRB breakdown, assessed by OCT-Leakage
measure: Retinal thickness quantification
time frame: 5 years
description: Retinal nerve fiber layer thickness (RNFL) and ganglion cells layer (GCL) + inner plexiform layer thickness (IPL) thickness, assessed by layer-by-layer SD-OCT
measure: mfERG assessement
time frame: 5 years
description: P1 implicit time and P1 amplitude by ring
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Portugal
responsible party type: Sponsor
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
sharing ipd: Yes