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/NCT05963646</url>
    </required_header>
    <id_info>
      <org_study_id>OMEGA</org_study_id>
      <nct_id>NCT05963646</nct_id>
    </id_info>
    <brief_title>Optical Coherence Tomography and Microperimetry Biomarker Evaluation in Patients With Geographic Atrophy Study</brief_title>
    <acronym>OMEGA</acronym>
    <official_title>Optical Coherence Tomography and Microperimetry Biomarker Evaluation in Patients With Geographic Atrophy Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute of Molecular and Clinical Ophthalmology Basel</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Boehringer Ingelheim</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Institute of Molecular and Clinical Ophthalmology Basel</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>
        This study is a biomarker evaluation study in patients with geographic atrophy secondary to&#xD;
        age-related macular degeneration (AMD). The study evaluates microperimetry (fundus-controlled&#xD;
        perimetry) and optical coherence tomography imaging for assessing changes in retinal&#xD;
        sensitivity and anatomy over time.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The optical coherence tomography (OCT) and microperimetry biomarker evaluation in patients&#xD;
        with GA (OMEGA) study aims to systematically compare a panel of established and novel visual&#xD;
        function and structural outcome measures for monitoring GA progression. This prospective,&#xD;
        natural-history study was performed at a tertiary referral center (University Hospital Basel,&#xD;
        PI: Prof. Dr. med. Hendrik P.N. Scholl). The study included a baseline visit and follow-up&#xD;
        visits at weeks 12, 24, and 48.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 16, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Actual">June 23, 2023</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in retinal sensitivity in the junctional zone</measure>
      <time_frame>Week 12</time_frame>
      <description>Change from baseline in retinal sensitivity in the junctional zone and in the perilesional zone of the largest atrophic loci as assessed by microperimetry</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in retinal pigment epithelium (RPE) thickness in the junctional zone</measure>
      <time_frame>Week 12</time_frame>
      <description>Change from baseline in retinal pigment epithelium (RPE) layer thickness in the junctional zone and in the perilesional zone measured by OCT</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in photoreceptor thickness in the junctional zone</measure>
      <time_frame>Week 12</time_frame>
      <description>Change from baseline in photoreceptor layer thickness in the junctional zone and in the perilesional zone measured by OCT</description>
    </primary_outcome>
    <enrollment type="Actual">30</enrollment>
    <condition>Age-Related Macular Degeneration</condition>
    <condition>Geographic Atrophy</condition>
    <condition>Visual Field Defect, Central Scotoma of Both Eyes</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Natural history study</intervention_name>
      <description>Patients were monitored with a panel of visual function tests and imaging modalities. Functional tests included best-corrected visual acuity (BCVA), low-luminance visual acuity (LLVA), and contrast sensitivity function evaluation (qCSF method). Imaging assessments included fundus autofluorescence, optical coherence tomography and optical coherence tomography angiography.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with manifest geographic atrophy (total GA lesion size &gt;1.2 mm2) secondary to&#xD;
          age-related macular degeneration&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Signed and dated written informed consent in accordance with ICH-GCP and local&#xD;
               legislation prior to admission to the study&#xD;
  &#xD;
            2. Age &gt;60 years&#xD;
  &#xD;
            3. Ability (including a sufficient general health status according to investigators&#xD;
               judgement) and willingness to undertake all scheduled visits and assessments including&#xD;
               predefined methodology and standards utilizing microperimetry&#xD;
  &#xD;
            4. GA secondary to AMD with no evidence of prior or active choroidal neovascularization&#xD;
               (CNV) in the study eye&#xD;
  &#xD;
            5. GA lesion in the study eye must reside completely within the FAF imaging field (Field&#xD;
               2-30 degree image centered on the fovea)&#xD;
  &#xD;
            6. BCVA of 20/63 or better (Snellen equivalent) using ETDRS charts at starting distance&#xD;
               of 4 m in the study eye&#xD;
  &#xD;
            7. Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active CNV&#xD;
               in the study eye. The total GA lesion size &gt;1.2 mm2 (approximately &gt;0.5 disc area&#xD;
               [DA]) and &lt;17.78 mm2 (approximately &lt;7 DA) and must reside completely within the FAF&#xD;
               imaging field (Field 2, i.e., 30 degree image centered on the fovea). If GA is&#xD;
               multifocal, at least 1 focal lesion must be &gt;1.2 mm2 (approximately &gt;0.5 DA).&#xD;
  &#xD;
            8. Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit&#xD;
               quality fundus imaging in the study eye.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. GA in either eye due to causes other than AMD (for example, monogenetic macular&#xD;
               dystrophies [e.g., Stargardt disease, cone rod dystrophy] or toxic maculopathies&#xD;
               [e.g., chloroquine/hydroxychloroquine maculopathy])&#xD;
  &#xD;
            2. Receiving active treatment in any studies of investigational drugs for GA/dry AMD in&#xD;
               the study eye&#xD;
  &#xD;
            3. Mean sensitivity difference &gt; 3 dB between the two microperimetry examinations in the&#xD;
               screening visit.&#xD;
  &#xD;
            4. History of vitrectomy surgery, submacular surgery, or other surgical intervention for&#xD;
               AMD in the study eye&#xD;
  &#xD;
            5. Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein&#xD;
               occlusion, and proliferative diabetic retinopathy in the study eye&#xD;
  &#xD;
            6. Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary&#xD;
               thermotherapy in the study eye&#xD;
  &#xD;
            7. History of prophylactic subthreshold laser treatment for AMD in the study eye&#xD;
  &#xD;
            8. Previous intravitreal drug delivery in the study eye (e.g., intravitreal&#xD;
               corticosteroid injection, anti-angiogenic drugs, anti complement agents, or device&#xD;
               implantation). A single intraoperative administration of a corticosteroid during&#xD;
               cataract surgery for cystoid macular edema prophylaxis at least 3 months prior to&#xD;
               screening is permitted.&#xD;
  &#xD;
            9. RPE tear that involves the macula in either eye&#xD;
  &#xD;
           10. Any concurrent ocular or intraocular condition in the study eye (e.g., cataract or&#xD;
               diabetic retinopathy) that, in the opinion of the investigator, could do either of the&#xD;
               following:&#xD;
  &#xD;
                 -  Require medical or surgical intervention during the study period to prevent or&#xD;
                    treat vision loss that might result from that condition&#xD;
  &#xD;
                 -  If allowed to progress untreated, could likely contribute to loss of at least two&#xD;
                    Snellen equivalent lines of BCVA during the study period&#xD;
  &#xD;
           11. Previous violation of the posterior capsule in the study eye unless it occurred as a&#xD;
               result of Yttrium Aluminum Garnet (YAG) laser posterior capsulotomy in association&#xD;
               with prior posterior chamber intraocular lens implantation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>University Hospital Basel</name>
        <address>
          <city>Basel</city>
          <state>Basel-Stadt</state>
          <zip>CH-4031</zip>
          <country>Switzerland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <link>
      <url>https://iob.ch/</url>
      <description>Institute of Molecular and Clinical Ophthalmology Basel</description>
    </link>
    <reference>
      <citation>Holz FG, Bindewald-Wittich A, Fleckenstein M, Dreyhaupt J, Scholl HP, Schmitz-Valckenberg S; FAM-Study Group. Progression of geographic atrophy and impact of fundus autofluorescence patterns in age-related macular degeneration. Am J Ophthalmol. 2007 Mar;143(3):463-72. doi: 10.1016/j.ajo.2006.11.041. Epub 2006 Dec 22.</citation>
      <PMID>17239336</PMID>
    </reference>
    <reference>
      <citation>Pfau M, Muller PL, von der Emde L, Lindner M, Moller PT, Fleckenstein M, Holz FG, Schmitz-Valckenberg S. MESOPIC AND DARK-ADAPTED TWO-COLOR FUNDUS-CONTROLLED PERIMETRY IN GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2020 Jan;40(1):169-180. doi: 10.1097/IAE.0000000000002337.</citation>
      <PMID>30300264</PMID>
    </reference>
    <reference>
      <citation>Pfau M, von der Emde L, de Sisternes L, Hallak JA, Leng T, Schmitz-Valckenberg S, Holz FG, Fleckenstein M, Rubin DL. Progression of Photoreceptor Degeneration in Geographic Atrophy Secondary to Age-related Macular Degeneration. JAMA Ophthalmol. 2020 Oct 1;138(10):1026-1034. doi: 10.1001/jamaophthalmol.2020.2914.</citation>
      <PMID>32789526</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Microperimetry</keyword>
    <keyword>Fundus-controlled perimetry</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Scotoma</mesh_term>
      <mesh_term>Macular Degeneration</mesh_term>
      <mesh_term>Geographic Atrophy</mesh_term>
      <mesh_term>Atrophy</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/NCT05963646
  org study id: OMEGA
  nct id: NCT05963646
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is a biomarker evaluation study in patients with geographic atrophy secondary to
        age-related macular degeneration (AMD). The study evaluates microperimetry (fundus-controlled
        perimetry) and optical coherence tomography imaging for assessing changes in retinal
        sensitivity and anatomy over time.
  The optical coherence tomography (OCT) and microperimetry biomarker evaluation in patients
        with GA (OMEGA) study aims to systematically compare a panel of established and novel visual
        function and structural outcome measures for monitoring GA progression. This prospective,
        natural-history study was performed at a tertiary referral center (University Hospital Basel,
        PI: Prof. Dr. med. Hendrik P.N. Scholl). The study included a baseline visit and follow-up
        visits at weeks 12, 24, and 48.
  observational model: Cohort
  time perspective: Prospective
  measure: Change in retinal sensitivity in the junctional zone
  time frame: Week 12
  description: Change from baseline in retinal sensitivity in the junctional zone and in the perilesional zone of the largest atrophic loci as assessed by microperimetry
  measure: Change in retinal pigment epithelium (RPE) thickness in the junctional zone
  time frame: Week 12
  description: Change from baseline in retinal pigment epithelium (RPE) layer thickness in the junctional zone and in the perilesional zone measured by OCT
  measure: Change in photoreceptor thickness in the junctional zone
  time frame: Week 12
  description: Change from baseline in photoreceptor layer thickness in the junctional zone and in the perilesional zone measured by OCT
  intervention type: Diagnostic Test
  intervention name: Natural history study
  description: Patients were monitored with a panel of visual function tests and imaging modalities. Functional tests included best-corrected visual acuity (BCVA), low-luminance visual acuity (LLVA), and contrast sensitivity function evaluation (qCSF method). Imaging assessments included fundus autofluorescence, optical coherence tomography and optical coherence tomography angiography.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  facility: 
  country: Switzerland
  url: https://iob.ch/
  description: Institute of Molecular and Clinical Ophthalmology Basel
  citation: Holz FG, Bindewald-Wittich A, Fleckenstein M, Dreyhaupt J, Scholl HP, Schmitz-Valckenberg S; FAM-Study Group. Progression of geographic atrophy and impact of fundus autofluorescence patterns in age-related macular degeneration. Am J Ophthalmol. 2007 Mar;143(3):463-72. doi: 10.1016/j.ajo.2006.11.041. Epub 2006 Dec 22.
  PMID: 17239336
  citation: Pfau M, Muller PL, von der Emde L, Lindner M, Moller PT, Fleckenstein M, Holz FG, Schmitz-Valckenberg S. MESOPIC AND DARK-ADAPTED TWO-COLOR FUNDUS-CONTROLLED PERIMETRY IN GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2020 Jan;40(1):169-180. doi: 10.1097/IAE.0000000000002337.
  PMID: 30300264
  citation: Pfau M, von der Emde L, de Sisternes L, Hallak JA, Leng T, Schmitz-Valckenberg S, Holz FG, Fleckenstein M, Rubin DL. Progression of Photoreceptor Degeneration in Geographic Atrophy Secondary to Age-related Macular Degeneration. JAMA Ophthalmol. 2020 Oct 1;138(10):1026-1034. doi: 10.1001/jamaophthalmol.2020.2914.
  PMID: 32789526
  responsible party type: Sponsor
  mesh term: Scotoma
  mesh term: Macular Degeneration
  mesh term: Geographic Atrophy
  mesh term: Atrophy
  sharing ipd: Undecided