<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/NCT02207712</url>
  </required_header>
  <id_info>
    <org_study_id>PPX-2014-004</org_study_id>
    <nct_id>NCT02207712</nct_id>
  </id_info>
  <brief_title>Noctura400 Treatment for Diabetic Retinopathy (CANDLE)</brief_title>
  <acronym>CANDLE</acronym>
  <official_title>Noctura400 Treatment for Diabetic Retinopathy: Pilot Study to Demonstrate and Evaluate the Care Pathway for National Health Service (NHS) Adoption</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PolyPhotonix Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PolyPhotonix Medical</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators aim to use light masks (Noctura 400) to test the hypothesis&#xD;
      that preventing the dark adaptation and associated hypoxia of the rods in the eye could in&#xD;
      turn prevent or halt the progression of centre-involving Diabetic Macular Oedema (DMO). DMO&#xD;
      is a devastating disease that is the most common cause of registerable blindness in the&#xD;
      working age-group in the United Kingdom (UK)&#xD;
&#xD;
      This is a multi-centred randomised controlled trial involving 240 patients. Post&#xD;
      randomization, participants in the intervention arm will wear the Noctura 400 Light Mask at&#xD;
      night for 48 weeks in conjunction with their routine, prescribed treatment of intravitreal&#xD;
      (eye) ranibizumab. Those in the standard arm will receive their routine, prescribed&#xD;
      ranibizumab treatment only.&#xD;
&#xD;
      The primary objective is to determine whether utilizing the Noctura 400 Light Mask at night&#xD;
      reduces the number of intravitreal injections of ranibizumab required by patients undergoing&#xD;
      such a course for the treatment of DMO.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetes is regarded by the World Health Organisation (WHO) as a global epidemic, with the&#xD;
      global diabetic population anticipated to exceed 500 million by 2020. In the UK there are&#xD;
      over 3.5 million people who have diabetes with a growth rate exceeding 150,000 people per&#xD;
      year. Diabetic Retinopathy (DR) is the most common complication of diabetes, and the most&#xD;
      common cause of sight threatening retinopathy is Diabetic Macular Oedema (DMO).&#xD;
&#xD;
      This condition is characterised by leakage of fluid from compromised blood vessels in the&#xD;
      central retina and 240,000 (8%) people with diabetes in the UK have clinically significant&#xD;
      DMO, and 100,000 people with DMO have visual impairment. DMO is the most common cause of&#xD;
      registerable blindness in the working age-group in the UK. The Diabetic Eye Screening&#xD;
      Programme (DESP) annually photographs 3 million people with diabetes at a cost of £65 million&#xD;
      to ensure early diagnosis of these sight threatening complications. All patients with&#xD;
      diabetic maculopathy are referred to the Hospital Eye Service (HES).&#xD;
&#xD;
      Clinically significant macular oedema requires treatment. Non-central oedema is usually kept&#xD;
      under close monitoring or laser treatment is advocated. Centre involving macular oedema is&#xD;
      usually treated with intravitreal injections of inhibitors of Vascular Endothelial Growth&#xD;
      Factor (anti-VEGF). Whilst laser treatment can reduce the risk of moderate visual loss by&#xD;
      50%, it is not effective in restoring best corrected visual acuity (BCVA) and has&#xD;
      significant, quality of life impacting side effects. The anti-VEGF treatments are costly and&#xD;
      cause significant burden to patients, their care-givers and the healthcare system.&#xD;
&#xD;
      A patient with DR never leaves the HES. With diabetes on the rise the cost of care for this&#xD;
      ever increasing population is growing year on year. This is putting immense strain on the&#xD;
      resources and budgets of the healthcare system.&#xD;
&#xD;
      In this trial the investigators will explore the health and economic impact of a new, novel&#xD;
      therapy for DMO provided by the Noctura 400 Light Mask. The Light Mask provides a&#xD;
      non-invasive, light therapy that can be administered at home by the patients themselves. If&#xD;
      successful, the introduction of Noctura 400 Light Mask treatment could bring significant&#xD;
      benefits to both patients and the healthcare system.&#xD;
&#xD;
      This trial has been designed as a randomised control trial to allow the direct assessment of&#xD;
      the Noctura 400 treatment based on a comparison with a control arm of patients not receiving&#xD;
      this treatment. All participants in the trial will be due to undergo their first year of a&#xD;
      course of intravitreal injection of an anti-VEGF drug known as ranibizumab. Those in the&#xD;
      treatment arm will, in addition to this course of injections, wear the Noctura 400 Light Mask&#xD;
      each night for 48 weeks. Those in the standard, or control, arm will receive their course of&#xD;
      injections only.&#xD;
&#xD;
      The study will involve 240 participants who have been diagnosed with clinically significant&#xD;
      DMO and referred to the Hospital Eye Service (HES) for injections. The current threshold for&#xD;
      referral is central retinal thickening of 400um or greater. Once in the HES, potential&#xD;
      participants will be assessed for eligibility in clinic. These eligibility tests will form&#xD;
      the future participant's &quot;baseline visit&quot;. If eligible, patients will be invited to&#xD;
      participate in the study. The eligibility assessment requires no further tests to those&#xD;
      required by the routine care pathway.&#xD;
&#xD;
      After gaining informed consent, eligible and consenting participants will then be randomised&#xD;
      into either the intervention arm (those wearing the Noctura 400 Light Mask each night in&#xD;
      conjunction with their routine injections) or a standard arm (those receiving their&#xD;
      injections only) and will then be invited back to clinic to begin their allocated therapy.&#xD;
&#xD;
      At the first trial visit, those in the intervention arm will be given the Noctura 400 Light&#xD;
      Mask to take away with them and instructed how to use it. The Noctura 400 is powered and&#xD;
      programmed to last for precisely 12 weeks. Participants will be provided with a replacement&#xD;
      mask at appropriate appointments to ensure continuous treatment.&#xD;
&#xD;
      At each and every appointment all participants will undergo Optical Coherence Tomography&#xD;
      (OCT) measurements (for assessment of disease progression) and visual acuity (VA) tests. For&#xD;
      the first three visits all participants will be given intravitreal injections, following&#xD;
      this, participants in both arms will be given injections at appointments only if required&#xD;
      based on the results of the OCT and VA tests. Medical history, concomitant medications and&#xD;
      adverse events will be recorded at each visit. At weeks 0,12 and 48 patients will fill out&#xD;
      insomnia and sleepiness and quality of life questionnaires.&#xD;
&#xD;
      The Noctura 400 has the ability to sense and record when it has been used as a direct measure&#xD;
      of compliance. Sleep Mask data will be collected at weeks 12,24,26 and 48. If compliance is&#xD;
      low this will be discussed with the participant with the aim of increasing compliance. If at&#xD;
      any point during the trial the Noctura 400 Light Mask appears faulty it will be returned for&#xD;
      analysis and replaced.&#xD;
&#xD;
      The trial ends at the patient's last visit after 48 weeks of use. Participants will return&#xD;
      their Noctura 400 Light Masks for analysis and then patients in both arms are free to&#xD;
      continue their routine injections as prescribed by the current care pathway. Participants&#xD;
      will be made aware at the time of consenting that the Noctura 400 Light Mask will not be&#xD;
      available within the NHS at the end of the trial, but that the manufacturer intends for the&#xD;
      device to be available to purchase privately&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Major protocol deviations compromised the study.&#xD;
  </why_stopped>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">August 2023</completion_date>
  <primary_completion_date type="Actual">August 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of intravitreal injections of ranibizumab required by each study eye at 48 weeks</measure>
    <time_frame>48 Weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean difference from baseline Central sub-field thickness at 48 Weeks</measure>
    <time_frame>48 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean difference from baseline visual acuity at 48 weeks.</measure>
    <time_frame>48 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean difference in utility (quality of life).</measure>
    <time_frame>Baseline, 12 and 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the number of ranibizumab injections received by patients who have received at least three injections.</measure>
    <time_frame>Between weeks 12 and 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Central sub-field thickness over time</measure>
    <time_frame>12, 24,36 and 48 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pattern of injections given over the period of 48 weeks in both arms.</measure>
    <time_frame>48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events rates</measure>
    <time_frame>48 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Compliance of wearing the mask</measure>
    <time_frame>48 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in sleep pattern.</measure>
    <time_frame>48 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">252</enrollment>
  <condition>Diabetic Macular Oedema</condition>
  <arm_group>
    <arm_group_label>Standard Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Those receiving only their prescribed ranibizumab treatment only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Noctura 400 Eye Mask in conjunction with their prescribed ranibizumab treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Noctura 400 Eye Mask</intervention_name>
    <description>The intervention is the wearing of the eye mask</description>
    <arm_group_label>Intervention Arm</arm_group_label>
    <other_name>Noctura400</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranibizumab</intervention_name>
    <description>Standard ranibizumab treatment only</description>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_label>Standard Arm</arm_group_label>
    <other_name>Those receiving their standard ranibizumab treatment only</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        i. Subjects of either sex aged 18 years or over. ii. Diagnosis of diabetes mellitus (type 1&#xD;
        or type 2). iii. Presence of clinically significant centre-involving macular oedema&#xD;
        resultant from DR of ≥400µm (CST/CMT as measured by OCT, and is listed for ranibizumab&#xD;
        therapy in the study eye.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any potential participant will be excluded if they have:&#xD;
&#xD;
        i. Received any previous anti-VEGF/steroid intravitreal injections in the study eye in the&#xD;
        last 6 months.&#xD;
&#xD;
        ii. Presence of proliferative diabetic retinopathy (PDR) at screening.&#xD;
&#xD;
        iii. Significant systemic diseases know to affect visual function, other than diabetes&#xD;
        (e.g. Parkinson's disease or Alzheimer's disease).&#xD;
&#xD;
        iv. History of relevant sleeping disorders/insomnia .&#xD;
&#xD;
        v. A condition that would preclude participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Holland</last_name>
    <role>Study Chair</role>
    <affiliation>PolyPhotonix Medical</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ulrich Meyer-Bothling</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ashford &amp; St Peters Hospitals NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Berkshire NHS Foundation Trust</name>
      <address>
        <city>Reading</city>
        <state>Berkshire</state>
        <zip>RG1 5AN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hitchingbrooke Healthcare NHS Trust</name>
      <address>
        <city>Huntingdon</city>
        <state>Cambridgeshire</state>
        <zip>PE29 6NT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peterborough and Stamford Hospitals NHS Foundation Trust</name>
      <address>
        <city>Peterborough</city>
        <state>Cambridgeshire</state>
        <zip>PE3 9GZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Tees Hospitals NHS Foundation Trust</name>
      <address>
        <city>Middlesbrough</city>
        <state>Cleveland</state>
        <zip>TS4 3BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospitals NHS Trust</name>
      <address>
        <city>Truro</city>
        <state>Cornwall</state>
        <zip>TR1 3LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colchester Hospital University NHS Foundation Trust</name>
      <address>
        <city>Colchester</city>
        <state>Essex</state>
        <zip>CO4 5JL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glouchestershire Hospitals NHS Foundation Trust</name>
      <address>
        <city>Cheltenham</city>
        <state>Glouchestershire</state>
        <zip>GL53 7AG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Basingstoke and North Hampshire NHS Foundation Trust</name>
      <address>
        <city>Basingstoke</city>
        <state>Hampshire</state>
        <zip>RG24 9NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Lincolnshire and Goole NHS Trust</name>
      <address>
        <city>Scunthorpe</city>
        <state>Lincolnshire</state>
        <zip>DN15 7BH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Paget University Hospital NHS Foundation Trust</name>
      <address>
        <city>Great Yarmouth</city>
        <state>Norfolk</state>
        <zip>NR31 6LA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norfolk and Norwich University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Colney</city>
        <state>Norwich Norfolk</state>
        <zip>NR4 7UY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford Radcliffe Hospitals NHS Trust</name>
      <address>
        <city>Headington</city>
        <state>Oxford Oxfordshire</state>
        <zip>0X3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yeovil District Hospital NHS Foundation Trust</name>
      <address>
        <city>Yeovil</city>
        <state>Somerset</state>
        <zip>BA21 4AT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ashford &amp; St Peters Hospitals NHS Foundation Trust</name>
      <address>
        <city>Chertsey</city>
        <state>Surrey</state>
        <zip>KT16 0PZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Surrey County Hospital</name>
      <address>
        <city>Guildford</city>
        <state>Surrey</state>
        <zip>GU2 7XX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Yorkshire Hospitals NHS Trust</name>
      <address>
        <city>Wakefield</city>
        <state>West Yorkshire</state>
        <zip>WF1 4EE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Western Hospital</name>
      <address>
        <city>Swindon</city>
        <state>Wiltshire</state>
        <zip>SN3 6BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plymouth Hospitals NHS Trust</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.polyphotonix.com</url>
    <description>Sponsor Website</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Macular Oedema</keyword>
  <keyword>Diabetic retinopathy</keyword>
  <keyword>Noctura</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ranibizumab</mesh_term>
  </intervention_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/NCT02207712
org study id: PPX-2014-004
nct id: NCT02207712
lead sponsor: 
has dmc: Yes
In this study, the investigators aim to use light masks (Noctura 400) to test the hypothesis
      that preventing the dark adaptation and associated hypoxia of the rods in the eye could in
      turn prevent or halt the progression of centre-involving Diabetic Macular Oedema (DMO). DMO
      is a devastating disease that is the most common cause of registerable blindness in the
      working age-group in the United Kingdom (UK)

      This is a multi-centred randomised controlled trial involving 240 patients. Post
      randomization, participants in the intervention arm will wear the Noctura 400 Light Mask at
      night for 48 weeks in conjunction with their routine, prescribed treatment of intravitreal
      (eye) ranibizumab. Those in the standard arm will receive their routine, prescribed
      ranibizumab treatment only.

      The primary objective is to determine whether utilizing the Noctura 400 Light Mask at night
      reduces the number of intravitreal injections of ranibizumab required by patients undergoing
      such a course for the treatment of DMO.
Diabetes is regarded by the World Health Organisation (WHO) as a global epidemic, with the
      global diabetic population anticipated to exceed 500 million by 2020. In the UK there are
      over 3.5 million people who have diabetes with a growth rate exceeding 150,000 people per
      year. Diabetic Retinopathy (DR) is the most common complication of diabetes, and the most
      common cause of sight threatening retinopathy is Diabetic Macular Oedema (DMO).

      This condition is characterised by leakage of fluid from compromised blood vessels in the
      central retina and 240,000 (8%) people with diabetes in the UK have clinically significant
      DMO, and 100,000 people with DMO have visual impairment. DMO is the most common cause of
      registerable blindness in the working age-group in the UK. The Diabetic Eye Screening
      Programme (DESP) annually photographs 3 million people with diabetes at a cost of £65 million
      to ensure early diagnosis of these sight threatening complications. All patients with
      diabetic maculopathy are referred to the Hospital Eye Service (HES).

      Clinically significant macular oedema requires treatment. Non-central oedema is usually kept
      under close monitoring or laser treatment is advocated. Centre involving macular oedema is
      usually treated with intravitreal injections of inhibitors of Vascular Endothelial Growth
      Factor (anti-VEGF). Whilst laser treatment can reduce the risk of moderate visual loss by
      50%, it is not effective in restoring best corrected visual acuity (BCVA) and has
      significant, quality of life impacting side effects. The anti-VEGF treatments are costly and
      cause significant burden to patients, their care-givers and the healthcare system.

      A patient with DR never leaves the HES. With diabetes on the rise the cost of care for this
      ever increasing population is growing year on year. This is putting immense strain on the
      resources and budgets of the healthcare system.

      In this trial the investigators will explore the health and economic impact of a new, novel
      therapy for DMO provided by the Noctura 400 Light Mask. The Light Mask provides a
      non-invasive, light therapy that can be administered at home by the patients themselves. If
      successful, the introduction of Noctura 400 Light Mask treatment could bring significant
      benefits to both patients and the healthcare system.

      This trial has been designed as a randomised control trial to allow the direct assessment of
      the Noctura 400 treatment based on a comparison with a control arm of patients not receiving
      this treatment. All participants in the trial will be due to undergo their first year of a
      course of intravitreal injection of an anti-VEGF drug known as ranibizumab. Those in the
      treatment arm will, in addition to this course of injections, wear the Noctura 400 Light Mask
      each night for 48 weeks. Those in the standard, or control, arm will receive their course of
      injections only.

      The study will involve 240 participants who have been diagnosed with clinically significant
      DMO and referred to the Hospital Eye Service (HES) for injections. The current threshold for
      referral is central retinal thickening of 400um or greater. Once in the HES, potential
      participants will be assessed for eligibility in clinic. These eligibility tests will form
      the future participant's "baseline visit". If eligible, patients will be invited to
      participate in the study. The eligibility assessment requires no further tests to those
      required by the routine care pathway.

      After gaining informed consent, eligible and consenting participants will then be randomised
      into either the intervention arm (those wearing the Noctura 400 Light Mask each night in
      conjunction with their routine injections) or a standard arm (those receiving their
      injections only) and will then be invited back to clinic to begin their allocated therapy.

      At the first trial visit, those in the intervention arm will be given the Noctura 400 Light
      Mask to take away with them and instructed how to use it. The Noctura 400 is powered and
      programmed to last for precisely 12 weeks. Participants will be provided with a replacement
      mask at appropriate appointments to ensure continuous treatment.

      At each and every appointment all participants will undergo Optical Coherence Tomography
      (OCT) measurements (for assessment of disease progression) and visual acuity (VA) tests. For
      the first three visits all participants will be given intravitreal injections, following
      this, participants in both arms will be given injections at appointments only if required
      based on the results of the OCT and VA tests. Medical history, concomitant medications and
      adverse events will be recorded at each visit. At weeks 0,12 and 48 patients will fill out
      insomnia and sleepiness and quality of life questionnaires.

      The Noctura 400 has the ability to sense and record when it has been used as a direct measure
      of compliance. Sleep Mask data will be collected at weeks 12,24,26 and 48. If compliance is
      low this will be discussed with the participant with the aim of increasing compliance. If at
      any point during the trial the Noctura 400 Light Mask appears faulty it will be returned for
      analysis and replaced.

      The trial ends at the patient's last visit after 48 weeks of use. Participants will return
      their Noctura 400 Light Masks for analysis and then patients in both arms are free to
      continue their routine injections as prescribed by the current care pathway. Participants
      will be made aware at the time of consenting that the Noctura 400 Light Mask will not be
      available within the NHS at the end of the trial, but that the manufacturer intends for the
      device to be available to purchase privately
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The number of intravitreal injections of ranibizumab required by each study eye at 48 weeks
time frame: 48 Weeks
measure: Mean difference from baseline Central sub-field thickness at 48 Weeks
time frame: 48 Weeks
measure: Mean difference from baseline visual acuity at 48 weeks.
time frame: 48 Weeks
measure: Mean difference in utility (quality of life).
time frame: Baseline, 12 and 48 weeks
measure: Difference in the number of ranibizumab injections received by patients who have received at least three injections.
time frame: Between weeks 12 and 48
measure: Change in Central sub-field thickness over time
time frame: 12, 24,36 and 48 Weeks
measure: Pattern of injections given over the period of 48 weeks in both arms.
time frame: 48 weeks
measure: Adverse events rates
time frame: 48 months
measure: Compliance of wearing the mask
time frame: 48 weeks
measure: Changes in sleep pattern.
time frame: 48 months
arm group label: Standard Arm
arm group type: Active Comparator
description: Those receiving only their prescribed ranibizumab treatment only
arm group label: Intervention Arm
arm group type: Experimental
description: Noctura 400 Eye Mask in conjunction with their prescribed ranibizumab treatment.
intervention type: Device
intervention name: Noctura 400 Eye Mask
description: The intervention is the wearing of the eye mask
arm group label: Intervention Arm
other name: Noctura400
intervention type: Drug
intervention name: Ranibizumab
description: Standard ranibizumab treatment only
arm group label: Intervention Arm
arm group label: Standard Arm
other name: Those receiving their standard ranibizumab treatment only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Martin Holland
role: Study Chair
affiliation: PolyPhotonix Medical
last name: Ulrich Meyer-Bothling
role: Principal Investigator
affiliation: Ashford & St Peters Hospitals NHS Trust
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country: United Kingdom
url: http://www.polyphotonix.com
description: Sponsor Website
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Ranibizumab
sharing ipd: No