<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/NCT02200263</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00088335</org_study_id>
    <nct_id>NCT02200263</nct_id>
  </id_info>
  <brief_title>The Effects of Lutein and Zeaxanthin Supplementation on Vision in Patients With Albinism</brief_title>
  <acronym>LUVIA</acronym>
  <official_title>A Randomized Placebo-controlled Trial to Investigate the Effect of Lutein and Zeaxanthin Supplementation on Macular Pigment and Visual Function in Albinism - LUtein for VIsion in Albinism (LUVIA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clark Charitable Foundation Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The LUVIA study is a randomized placebo-controlled trial designed to investigate the effects&#xD;
      of lutein and zeaxanthin supplementation on macular pigment and visual function in ocular or&#xD;
      oculocutaneous albinism. Lutein and zeaxanthin supplementation will be compared to a placebo&#xD;
      (no treatment) gel pill over the period of 12 months, with study visits approximately every 3&#xD;
      months for the first year and a final visit 18 months after enrollment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ocular and oculocutaneous albinism represent a spectrum of disorders with absent or&#xD;
      significantly diminished amount of melanin either across different body tissues - skin, hair,&#xD;
      eye (Oculocutaneous Albinism 1 and 2), or exclusively in eye tissues only (Ocular Albinism 1)&#xD;
      .&#xD;
&#xD;
      The functionality and the clinical findings are diverse (the phenotype), and no direct&#xD;
      correlation has been established to the underlying mutations (genotype).&#xD;
&#xD;
      The common ocular phenotype includes iris transillumination, foveal hypoplasia, nystagmus,&#xD;
      reduced visual acuity, refractive error, photosensitivity and abnormal development of the&#xD;
      visual pathways with characteristic abnormal routing of ganglion cell axons in the chiasma,&#xD;
      resulting in abnormal visually evoked potentials. Current treatment options are limited to&#xD;
      optical methods and low vision aids.&#xD;
&#xD;
      The mechanism of melanin pigment formation in the RPE cells and its role in the visual&#xD;
      pathways and structures development is not completely understood, but a correlation was found&#xD;
      between the amount of fundus pigmentation and visual function in albino patients. The absent&#xD;
      pigmentation within the retinal pigment epithelium (RPE) may thus contribute to visual&#xD;
      performance deficits.&#xD;
&#xD;
      The macular pigment (MP) consists of two main carotenoids, lutein and zeaxanthin, which are&#xD;
      concentrated in the macular region of the retina. MP is hypothesized to function via a&#xD;
      protective mechanism by absorbing blue light incident on the retina thereby reducing&#xD;
      oxidative damage to the underlying photoreceptors. It is also thought to improve visual&#xD;
      function via reduction of chromatic aberration and glare. It is currently unclear as to how&#xD;
      the variability in macular pigment optical density (MPOD) affects congenital retinal&#xD;
      conditions. The MP would, however, be a hypothetical and good candidate to improve visual&#xD;
      performance - simply by increasing pigmentation, reducing light scatter and thus glare&#xD;
      sensitivity.&#xD;
&#xD;
      As this pigment is not produced in the retina, but is absorbed via diet, it can be&#xD;
      manipulated by alteration in diet and supplementation thereby providing potential therapy for&#xD;
      retinal diseases. It is however necessary first to see if MPOD levels are measurable in this&#xD;
      disorder before dietary advice can be provided after completion of the LUVIA study. Further&#xD;
      to this, evaluation of both the structural and functional properties of the retina will&#xD;
      provide greater insight into the possible function of MP in this retinal disease including&#xD;
      whether supplementation would be of benefit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <phase>N/A</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Macular pigment optical density (MPOD)</measure>
    <time_frame>12 months</time_frame>
    <description>MPOD will be measured at baseline and follow-up. MPOD will be evaluated psychophysically using the QuantifEye device (ZeaVision), optically using the MPOD module of the Heidelberg Spectralis multicolor imaging device, and by quantitative fundus autofluorescence (FAF) using the Heidelberg Spectralis multicolor imaging device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Contrast acuity</measure>
    <time_frame>12 months</time_frame>
    <description>Contrast acuity will be measured at baseline and follow-up using the Innova electronic visual system and the quick Contrast Sensitivity Function (Adaptive Sensory Technology, LLC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual field, fixation and central retinal sensitivity</measure>
    <time_frame>12 months</time_frame>
    <description>Microperimetry testing via the microperimetry (MP) -1 device (Nidek) will be performed at baseline and follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bioavailability profile of Lutein and Zeaxanthin</measure>
    <time_frame>12 months</time_frame>
    <description>Blood samples will be collected at follow-up, and Lutein and Zeaxanthin concentration levels assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the diversity of microstructural central retinal abnormalities</measure>
    <time_frame>12 months</time_frame>
    <description>Spectral domain ocular coherence tomography (SD-OCT) macular scan will be performed at baseline and at 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Corrected Visual Acuity (BCVA)</measure>
    <time_frame>12 months</time_frame>
    <description>BCVA will evaluated using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at baseline and follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Ocular Albinism (OA)</condition>
  <condition>Oculocutaneous Albinism (OCA)</condition>
  <arm_group>
    <arm_group_label>Lutein plus Zeaxanthin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this arm will receive 20 mg of Lutein (L) plus 20 mg of Zeaxanthin (Z) per day: Two pills (10 mg L+ 10 mg Z per pill) for the duration of one year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo softgels</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants randomized to this arm will receive two pills per day of placebo-gels corresponding to the active compound in look and feel for the duration of one year</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lutein plus Zeaxanthin</intervention_name>
    <description>dose: two softgels once a day with a meal</description>
    <arm_group_label>Lutein plus Zeaxanthin</arm_group_label>
    <other_name>EyePromise® Lutein + Zeaxanthin (ZeaVision, LLC)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>two softgels once-daily with a meal</description>
    <arm_group_label>Placebo softgels</arm_group_label>
    <other_name>placebo softgels</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of 12 years old and older&#xD;
&#xD;
          -  Clinical and/or genetic diagnosis of ocular or oculocutaneous albinism&#xD;
&#xD;
          -  Ocular media allowing acceptable visualization of the retina.&#xD;
&#xD;
          -  Ocular media allowing acceptable quality of the ocular coherence tomography (OCT)&#xD;
             and/or fundus autofluorescence (FAF) scans.&#xD;
&#xD;
          -  At least one reliable central macular pigment optical density (MPOD) measurement&#xD;
             captured on the enrollment visit in at least one eligible eye&#xD;
&#xD;
          -  Best corrected visual acuity of 20/200 or better in one or both eligible eyes (eyes&#xD;
             that confirmed to be eligible by the MPOD testing).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons taking lutein and/or zeaxanthin supplements over the past 6 months&#xD;
&#xD;
          -  Pregnant or planning to become pregnant&#xD;
&#xD;
          -  Evidence of present or past retinal macular condition other than congenital foveal&#xD;
             hypoplasia&#xD;
&#xD;
          -  History of gastrointestinal disease that would interfere with absorption of lutein and&#xD;
             zeaxanthin&#xD;
&#xD;
          -  Participation in a clinical trial requiring visual testing or administration of a drug&#xD;
             (marketed or investigational) within 60 days before entry in the study (the day&#xD;
             informed consent is signed)&#xD;
&#xD;
          -  Inability to communicate or cooperate with the investigator due to cognitive&#xD;
             impairment or poor general health&#xD;
&#xD;
          -  Any other condition which, in the opinion of the investigators, is likely to interfere&#xD;
             with the successful collection of the measures required for the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil Bressler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mary E. Frey</last_name>
    <role>Study Director</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wilmer Eye Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287-9277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>December 27, 2018</last_update_submitted>
  <last_update_submitted_qc>December 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ocular albinism (OA)</keyword>
  <keyword>oculocutaneous albinism (OCA)</keyword>
  <keyword>macular pigment</keyword>
  <keyword>visual function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Albinism</mesh_term>
    <mesh_term>Albinism, Oculocutaneous</mesh_term>
    <mesh_term>Albinism, Ocular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02200263
org study id: NA_00088335
nct id: NCT02200263
lead sponsor: 
collaborator: 
has dmc: Yes
The LUVIA study is a randomized placebo-controlled trial designed to investigate the effects
      of lutein and zeaxanthin supplementation on macular pigment and visual function in ocular or
      oculocutaneous albinism. Lutein and zeaxanthin supplementation will be compared to a placebo
      (no treatment) gel pill over the period of 12 months, with study visits approximately every 3
      months for the first year and a final visit 18 months after enrollment.
Ocular and oculocutaneous albinism represent a spectrum of disorders with absent or
      significantly diminished amount of melanin either across different body tissues - skin, hair,
      eye (Oculocutaneous Albinism 1 and 2), or exclusively in eye tissues only (Ocular Albinism 1)
      .

      The functionality and the clinical findings are diverse (the phenotype), and no direct
      correlation has been established to the underlying mutations (genotype).

      The common ocular phenotype includes iris transillumination, foveal hypoplasia, nystagmus,
      reduced visual acuity, refractive error, photosensitivity and abnormal development of the
      visual pathways with characteristic abnormal routing of ganglion cell axons in the chiasma,
      resulting in abnormal visually evoked potentials. Current treatment options are limited to
      optical methods and low vision aids.

      The mechanism of melanin pigment formation in the RPE cells and its role in the visual
      pathways and structures development is not completely understood, but a correlation was found
      between the amount of fundus pigmentation and visual function in albino patients. The absent
      pigmentation within the retinal pigment epithelium (RPE) may thus contribute to visual
      performance deficits.

      The macular pigment (MP) consists of two main carotenoids, lutein and zeaxanthin, which are
      concentrated in the macular region of the retina. MP is hypothesized to function via a
      protective mechanism by absorbing blue light incident on the retina thereby reducing
      oxidative damage to the underlying photoreceptors. It is also thought to improve visual
      function via reduction of chromatic aberration and glare. It is currently unclear as to how
      the variability in macular pigment optical density (MPOD) affects congenital retinal
      conditions. The MP would, however, be a hypothetical and good candidate to improve visual
      performance - simply by increasing pigmentation, reducing light scatter and thus glare
      sensitivity.

      As this pigment is not produced in the retina, but is absorbed via diet, it can be
      manipulated by alteration in diet and supplementation thereby providing potential therapy for
      retinal diseases. It is however necessary first to see if MPOD levels are measurable in this
      disorder before dietary advice can be provided after completion of the LUVIA study. Further
      to this, evaluation of both the structural and functional properties of the retina will
      provide greater insight into the possible function of MP in this retinal disease including
      whether supplementation would be of benefit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Macular pigment optical density (MPOD)
time frame: 12 months
description: MPOD will be measured at baseline and follow-up. MPOD will be evaluated psychophysically using the QuantifEye device (ZeaVision), optically using the MPOD module of the Heidelberg Spectralis multicolor imaging device, and by quantitative fundus autofluorescence (FAF) using the Heidelberg Spectralis multicolor imaging device
measure: Contrast acuity
time frame: 12 months
description: Contrast acuity will be measured at baseline and follow-up using the Innova electronic visual system and the quick Contrast Sensitivity Function (Adaptive Sensory Technology, LLC)
measure: Visual field, fixation and central retinal sensitivity
time frame: 12 months
description: Microperimetry testing via the microperimetry (MP) -1 device (Nidek) will be performed at baseline and follow-up
measure: Bioavailability profile of Lutein and Zeaxanthin
time frame: 12 months
description: Blood samples will be collected at follow-up, and Lutein and Zeaxanthin concentration levels assessed.
measure: Evaluation of the diversity of microstructural central retinal abnormalities
time frame: 12 months
description: Spectral domain ocular coherence tomography (SD-OCT) macular scan will be performed at baseline and at 12 months
measure: Best Corrected Visual Acuity (BCVA)
time frame: 12 months
description: BCVA will evaluated using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at baseline and follow-up
arm group label: Lutein plus Zeaxanthin
arm group type: Experimental
description: Participants randomized to this arm will receive 20 mg of Lutein (L) plus 20 mg of Zeaxanthin (Z) per day: Two pills (10 mg L+ 10 mg Z per pill) for the duration of one year.
arm group label: Placebo softgels
arm group type: Placebo Comparator
description: Participants randomized to this arm will receive two pills per day of placebo-gels corresponding to the active compound in look and feel for the duration of one year
intervention type: Dietary Supplement
intervention name: Lutein plus Zeaxanthin
description: dose: two softgels once a day with a meal
arm group label: Lutein plus Zeaxanthin
other name: EyePromise® Lutein + Zeaxanthin (ZeaVision, LLC)
intervention type: Dietary Supplement
intervention name: Placebo
description: two softgels once-daily with a meal
arm group label: Placebo softgels
other name: placebo softgels
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Neil Bressler, MD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Mary E. Frey
role: Study Director
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Albinism
mesh term: Albinism, Oculocutaneous
mesh term: Albinism, Ocular
sharing ipd: No