<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/NCT02984813</url>
  </required_header>
  <id_info>
    <org_study_id>15.25</org_study_id>
    <nct_id>NCT02984813</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Anti-Oxidants and Anti-inflammatory Agents in Glaucoma and Diabetic Retinopathy</brief_title>
  <official_title>Measurement of Oxidative Stress of Retinal Ganglion Cells With and Without Anti-oxidants and Anti-inflammatory Agents in Patients With Glaucoma and Diabetic Retinopathy as Determined by Mitochondrial Flavoprotein Fluorescence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The New York Eye &amp; Ear Infirmary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The New York Eye &amp; Ear Infirmary</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a multi-armed protocol designed to evaluate the safety and efficacy of two&#xD;
      different combinations of nutritional supplements (study drug) (Glauco-Health and&#xD;
      Glauco-Select) chosen for their potential to protect retinal ganglion cells against oxidative&#xD;
      stress, low-grade inflammation, and mitochondrial dysfunction in patients with open-angle&#xD;
      glaucoma and diabetic retinopathy. Oxidative stress and retinal cellular dysfunction will be&#xD;
      measured using a Retinal Metabolic Analyzer (RMA) in this randomized, single center, double&#xD;
      masked study. Patients with glaucoma will be divided into three treatment arms randomized to&#xD;
      receive either Glauco-Health, Glauco-Select, or placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This investigation is using over the counter supplements. The investigation is intended only&#xD;
      to evaluate their effect on the structure or function of mitochondria as it relates to the&#xD;
      autofluorescence imaging being conducted in the study. They are not being studied to evaluate&#xD;
      their ability to diagnose, cure, mitigate, or treat disease.&#xD;
&#xD;
      These ingredients in these combinations of nutritional supplements have also been reported&#xD;
      beneficial in diabetic retinopathy. Patients with diabetic retinopathy will be added later as&#xD;
      an additional arm and an amendment to this effect will be submitted when that portion of the&#xD;
      study is ready to be initiated. That amendment will include background material, appropriate&#xD;
      inclusion and exclusion criteria, informed consent, and references. At the current time, only&#xD;
      the glaucoma proposal and glaucoma patients will be enrolled according to this submitted&#xD;
      protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Investigator left the institution&#xD;
  </why_stopped>
  <start_date type="Actual">April 15, 2016</start_date>
  <completion_date type="Actual">January 15, 2017</completion_date>
  <primary_completion_date type="Actual">January 15, 2017</primary_completion_date>
  <phase>Phase 1</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Flavoprotein fluorescence index</measure>
    <time_frame>3 months</time_frame>
    <description>Average Intensity and Average Curve Width</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Humphrey visual field testing (24-2)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Open-angle Glaucoma</condition>
  <condition>Diabetic Retinopathy</condition>
  <arm_group>
    <arm_group_label>GlaucoHealth</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 pills once daily in the morning for 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GlaucoSelect</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 pills once daily in the morning for 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 pills once daily in the morning for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GlaucoHealth</intervention_name>
    <description>Containing alpha lipoic acid, citicoline, Co-enzyme Q10, Ginkgo biloba extract, grape seed extract, N-acetyl-cysteine, curcumin, and green tea extract</description>
    <arm_group_label>GlaucoHealth</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GlaucoSelect</intervention_name>
    <description>Containing curcumin, bilberry extract, and grape seed extract</description>
    <arm_group_label>GlaucoSelect</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>No active ingredients</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female of any race, at least 18 years of age.&#xD;
&#xD;
          2. Has provided verbal and written informed consent.&#xD;
&#xD;
          3. Able and willing to follow instructions, including participation in all study&#xD;
             assessments and visits.&#xD;
&#xD;
          4. Eyes with moderate to severe primary open-angle glaucoma will be enrolled. Glaucoma&#xD;
             severity will be graded using the WHO glaucoma staging system.&#xD;
&#xD;
               1. OAG eyes are defined by clinical findings consistent with glaucomatous optic&#xD;
                  neuropathy (Ex: thinning, excavation, rim erosion or notching of the neuroretinal&#xD;
                  rim)&#xD;
&#xD;
               2. Reproducible visual field defects on at least three examinations as measured by a&#xD;
                  glaucoma hemifield test (GHT) result outside normal limits and/or the presence of&#xD;
                  at least three consecutive test points on the pattern deviation plot with P&lt;1%&#xD;
                  and at least one at P&lt;0.05%, not including points on the edge of the field.&#xD;
&#xD;
          5. Both eyes will be enrolled.&#xD;
&#xD;
          6. Refractive error ≤5 diopters and astigmatism ≤3 diopters&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Comorbidity with other severe or chronic eye conditions that in the judgment of the&#xD;
             investigator will interfere with study assignment, such as age-related macular&#xD;
             degeneration, macular dystrophy, retinopathy from systemic diseases, marked ocular&#xD;
             media opacities that obscure retinal imaging, etc.&#xD;
&#xD;
          2. BCVA &lt;20/200&#xD;
&#xD;
          3. Concurrent conjunctivitis, keratitis or uveitis&#xD;
&#xD;
          4. History of penetrating ocular trauma.&#xD;
&#xD;
          5. Subject uncooperativeness that restricts adequate examination of IOP, ocular fundus or&#xD;
             anterior chamber.&#xD;
&#xD;
          6. Has a condition or history that, in the opinion of the investigator, may interfere&#xD;
             significantly with the subject's participation in the study.&#xD;
&#xD;
          7. A woman who is pregnant, nursing an infant, or planning a pregnancy&#xD;
&#xD;
          8. Has a known adverse reaction and/or sensitivity to the study drug or its compound.&#xD;
&#xD;
             a. Including: alpha lipoic acid, citicoline, Co-enzyme Q-10, Ginkgo biloba extract,&#xD;
             grape seed extract, N-acetyl-cysteine, curcumin, green tea extract, and bilberry&#xD;
             extract.&#xD;
&#xD;
          9. Currently enrolled in an investigational drug study or has used an investigational&#xD;
             drug within 30 days prior to Visit 1.&#xD;
&#xD;
         10. Is planning on having surgery at any time throughout the study duration (90 days from&#xD;
             initiation)&#xD;
&#xD;
         11. Is currently receiving chemotherapy&#xD;
&#xD;
         12. Has a history of diabetes mellitus, seizure(s), bleeding disorder(s)&#xD;
&#xD;
         13. Has a history of uncontrolled hypertension (≥180 systolic or ≥110 diastolic on two&#xD;
             successive measures)&#xD;
&#xD;
         14. Has a history of any radiation around the eyes&#xD;
&#xD;
         15. Currently using anticoagulant/antiplatelet drugs (patients on coumadin, clopidogral&#xD;
             (Plavix), and plasugrel (Effient) will be excluded but that patients taking aspirin&#xD;
             will be allowed)&#xD;
&#xD;
         16. Unwilling or unable to cease using other anti-oxidative agents or drugs.&#xD;
&#xD;
         17. Dilated pupil diameter less than 5 millimeters&#xD;
&#xD;
         18. Fluorescein drop administration within 8 hours before imaging&#xD;
&#xD;
         19. History of cataract surgery in the 3 months prior to imaging&#xD;
&#xD;
         20. History of any other intraocular surgery within 4 months prior to enrollment&#xD;
&#xD;
         21. Corticosteroid or immunosuppressive therapy within 6-months prior to imaging&#xD;
&#xD;
         22. Lens opacity ≥grade 3 on ARLNS on standard photographs (Appendix 6)&#xD;
&#xD;
         23. History of vitrectomy&#xD;
&#xD;
         24. Monocular patients&#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_official>
    <last_name>Robert Ritch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shelley and Steven Einhorn Distinguished Chair Professor of Ophthalmology Surgeon Director Emeritus and Chief, Glaucoma Services The New York Eye and Ear Infirmary of Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York Eye and Ear Infirmary of Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 3, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</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>Glaucoma</mesh_term>
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02984813
org study id: 15.25
nct id: NCT02984813
lead sponsor: 
has dmc: Yes
This study is a multi-armed protocol designed to evaluate the safety and efficacy of two
      different combinations of nutritional supplements (study drug) (Glauco-Health and
      Glauco-Select) chosen for their potential to protect retinal ganglion cells against oxidative
      stress, low-grade inflammation, and mitochondrial dysfunction in patients with open-angle
      glaucoma and diabetic retinopathy. Oxidative stress and retinal cellular dysfunction will be
      measured using a Retinal Metabolic Analyzer (RMA) in this randomized, single center, double
      masked study. Patients with glaucoma will be divided into three treatment arms randomized to
      receive either Glauco-Health, Glauco-Select, or placebo.
This investigation is using over the counter supplements. The investigation is intended only
      to evaluate their effect on the structure or function of mitochondria as it relates to the
      autofluorescence imaging being conducted in the study. They are not being studied to evaluate
      their ability to diagnose, cure, mitigate, or treat disease.

      These ingredients in these combinations of nutritional supplements have also been reported
      beneficial in diabetic retinopathy. Patients with diabetic retinopathy will be added later as
      an additional arm and an amendment to this effect will be submitted when that portion of the
      study is ready to be initiated. That amendment will include background material, appropriate
      inclusion and exclusion criteria, informed consent, and references. At the current time, only
      the glaucoma proposal and glaucoma patients will be enrolled according to this submitted
      protocol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Flavoprotein fluorescence index
time frame: 3 months
description: Average Intensity and Average Curve Width
measure: Visual acuity
time frame: 3 months
measure: Humphrey visual field testing (24-2)
time frame: 3 months
arm group label: GlaucoHealth
arm group type: Experimental
description: 2 pills once daily in the morning for 3 months
arm group label: GlaucoSelect
arm group type: Experimental
description: 2 pills once daily in the morning for 3 months
arm group label: Placebo
arm group type: Placebo Comparator
description: 2 pills once daily in the morning for 3 months
intervention type: Drug
intervention name: GlaucoHealth
description: Containing alpha lipoic acid, citicoline, Co-enzyme Q10, Ginkgo biloba extract, grape seed extract, N-acetyl-cysteine, curcumin, and green tea extract
arm group label: GlaucoHealth
intervention type: Drug
intervention name: GlaucoSelect
description: Containing curcumin, bilberry extract, and grape seed extract
arm group label: GlaucoSelect
intervention type: Drug
intervention name: Placebo
description: No active ingredients
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Ritch, MD
role: Principal Investigator
affiliation: Shelley and Steven Einhorn Distinguished Chair Professor of Ophthalmology Surgeon Director Emeritus and Chief, Glaucoma Services The New York Eye and Ear Infirmary of Mount Sinai
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Glaucoma, Open-Angle
sharing ipd: Undecided