<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/NCT04420923</url>
  </required_header>
  <id_info>
    <org_study_id>90953</org_study_id>
    <nct_id>NCT04420923</nct_id>
  </id_info>
  <brief_title>Optimizing the Treatment Strategy for Age-related Macular Degeneration</brief_title>
  <acronym>OnP2</acronym>
  <official_title>A Randomised Controlled Trial Testing the Efficacy of the Treatment Strategy Observe-and-Plan Against Standard Treat-and-Extend in a Population of Newly Referred Patients With Age-related Macular Degeneration.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Molde Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alesund Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Olavs Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to compare two different treatment protocols for wet macular&#xD;
      degeneration; the new protocol called &quot;Observe and Plan&quot; against the current standard&#xD;
      protocol &quot;Treat and Extend&quot;. Studies suggest that patients achieve equally good visual acuity&#xD;
      with fewer controls and that they are more satisfied with the new protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to test a new treatment protocol for wet macular degeneration,&#xD;
      called &quot;Observe and Plan&quot;, against today's standard protocol &quot;Treat and Extend&quot;. Studies&#xD;
      suggest that the individual treatment interval can be achieved earlier with&#xD;
      &quot;Observe-and-Plan&quot; and that a proportion of patients do not need more than 3 injections, ie&#xD;
      the loading dose. The other advantages seem to be that patients achieve good visual acuity&#xD;
      with fewer controls and are more satisfied with the new protocol, which will be beneficial to&#xD;
      both patients and health care. To our knowledge, no randomized controlled trial has tested&#xD;
      this before.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 31, 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>Visual acuity</measure>
    <time_frame>1 year</time_frame>
    <description>Number of letters read at the ETDRS chart will be tested for each eye starting with a test distance of 2 meter, after correction of the refraction. A standardized testing protocol will be used both for refraction and the visual acuity test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>2 years</time_frame>
    <description>Number of letters read at the ETDRS chart will be tested for each eye starting with a test distance of 2 meter, after correction of the refraction. A standardized testing protocol will be used both for refraction and the visual acuity test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction assessed by NEI-VFQ-25</measure>
    <time_frame>1 year</time_frame>
    <description>National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25). The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction assessed by NEI-VFQ-25</measure>
    <time_frame>2 years</time_frame>
    <description>National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25). The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of injections</measure>
    <time_frame>1 year</time_frame>
    <description>The number of injections will be counted for each participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of controls</measure>
    <time_frame>1 year</time_frame>
    <description>The number of controls by the ophthalmologist will be counted for each participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of injections</measure>
    <time_frame>2 years</time_frame>
    <description>The number of injections will be counted for each participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of controls</measure>
    <time_frame>2 years</time_frame>
    <description>The number of controls by the ophthalmologist will be counted for each participant.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Wet Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Observe-and-Plan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will follow the same protocol as described by dr. Mantel et al. (2014) in the first Observe-and-Plan study conducted in Lausanne.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treat-and-Extend</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will follow the standard treatment protocol for Treat-and-Extend, used for several years in the participating clinics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observe and Plan</intervention_name>
    <description>First the individual interval between the injections of anti-VEGF (vascular endothelial growth factor) is established by observing the time from the loading dose to recurrence of the disease. The patient will come to control every four weeks to establish this interval. Second, the patient will receive injections at intervals that are two weeks shorter than the observed period. 2-3 injections are given before the next control. The control should be no later than six months ahead.</description>
    <arm_group_label>Observe-and-Plan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treat-and-Extend</intervention_name>
    <description>At the first control 4 weeks after the loading dose, the ophthalmologist assesses whether the macula is still wet or whether the macula is dry. In case of wet macula, the patient receives a new injection on the same day and a new control in 4 weeks. If the macula is dry, the patient will return in 2 weeks for the next injection, ie the injection interval is extended from 4 to 6 weeks.&#xD;
Patients will be controlled every time they are to receive an intravitreal injection. If the macula is dry, the injection interval will be extended by 2 weeks and if the macula is wet the interval is shortened by 2 weeks. The shortest interval will be 4 weeks.</description>
    <arm_group_label>Treat-and-Extend</arm_group_label>
    <other_name>Standard treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed age-related macular degeneration according to criteria.&#xD;
&#xD;
          -  new diagnose of active CNV verified with OCTA or FA / ICGA.&#xD;
&#xD;
          -  BCVA ≥ 20/200 measured with ETDRS visual acuity chart&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Eyes formerly treated with anti-VEGF, photodynamic therapy, radiation therapy,&#xD;
             transpupillary thermotherapy or focal laser photocoagulation involving the macular&#xD;
             area.&#xD;
&#xD;
          -  Geographic atrophy and subretinal fibrosis affecting the patient's visual acuity.&#xD;
&#xD;
          -  Any other ongoing eye disease that influences patient's visual acuity, such as&#xD;
             glaucoma with central vision loss, proliferative diabetic retinopathy, diabetic&#xD;
             macular edema or chronic uveitis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dordi Austeng, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian University of Science and Technology, Fac MH, INB</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marit Fagerli, MD</last_name>
    <role>Study Director</role>
    <affiliation>Clinic of Ear-Nose-Throat, Eye and Maxillofacial Surgery, St. Olavs Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jorunn Helbostad, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology, Fac MH, INB</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Margrete Sætre Hanssen, MD</last_name>
    <phone>+47 91871727</phone>
    <email>margrete.saetre.hanssen@ntnu.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dordi Austeng, MD PhD</last_name>
    <email>dordi.austeng@ntnu.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Molde Hospital</name>
      <address>
        <city>Molde</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dept. of Ophthalmology, St Olavs Hospital, Trondheim University Hospital</name>
      <address>
        <city>Trondheim</city>
        <zip>N-7006</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ålesund Hospital</name>
      <address>
        <city>Ålesund</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Mantel I, Niderprim SA, Gianniou C, Deli A, Ambresin A. Reducing the clinical burden of ranibizumab treatment for neovascular age-related macular degeneration using an individually planned regimen. Br J Ophthalmol. 2014 Sep;98(9):1192-6. doi: 10.1136/bjophthalmol-2013-304556. Epub 2014 Apr 10.</citation>
    <PMID>24729031</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 9, 2022</last_update_submitted>
  <last_update_submitted_qc>June 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Outcome Assessment, Health Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Wet Macular Degeneration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>There is a plan to make IPD that underlie results in a publication and related data dictionaries available to other researchers.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The data will be available on request after publication.</ipd_time_frame>
    <ipd_access_criteria>The requests will be evaluated by the research group at the institute.</ipd_access_criteria>
  </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/NCT04420923
org study id: 90953
nct id: NCT04420923
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare two different treatment protocols for wet macular
      degeneration; the new protocol called "Observe and Plan" against the current standard
      protocol "Treat and Extend". Studies suggest that patients achieve equally good visual acuity
      with fewer controls and that they are more satisfied with the new protocol.
The purpose of the study is to test a new treatment protocol for wet macular degeneration,
      called "Observe and Plan", against today's standard protocol "Treat and Extend". Studies
      suggest that the individual treatment interval can be achieved earlier with
      "Observe-and-Plan" and that a proportion of patients do not need more than 3 injections, ie
      the loading dose. The other advantages seem to be that patients achieve good visual acuity
      with fewer controls and are more satisfied with the new protocol, which will be beneficial to
      both patients and health care. To our knowledge, no randomized controlled trial has tested
      this before.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual acuity
time frame: 1 year
description: Number of letters read at the ETDRS chart will be tested for each eye starting with a test distance of 2 meter, after correction of the refraction. A standardized testing protocol will be used both for refraction and the visual acuity test.
measure: Visual acuity
time frame: 2 years
description: Number of letters read at the ETDRS chart will be tested for each eye starting with a test distance of 2 meter, after correction of the refraction. A standardized testing protocol will be used both for refraction and the visual acuity test
measure: Patient satisfaction assessed by NEI-VFQ-25
time frame: 1 year
description: National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25). The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration.
measure: Patient satisfaction assessed by NEI-VFQ-25
time frame: 2 years
description: National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25). The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration.
measure: Number of injections
time frame: 1 year
description: The number of injections will be counted for each participant.
measure: Number of controls
time frame: 1 year
description: The number of controls by the ophthalmologist will be counted for each participant.
measure: Number of injections
time frame: 2 years
description: The number of injections will be counted for each participant.
measure: Number of controls
time frame: 2 years
description: The number of controls by the ophthalmologist will be counted for each participant.
arm group label: Observe-and-Plan
arm group type: Experimental
description: Patients will follow the same protocol as described by dr. Mantel et al. (2014) in the first Observe-and-Plan study conducted in Lausanne.
arm group label: Treat-and-Extend
arm group type: Active Comparator
description: Patients will follow the standard treatment protocol for Treat-and-Extend, used for several years in the participating clinics.
intervention type: Other
intervention name: Observe and Plan
description: First the individual interval between the injections of anti-VEGF (vascular endothelial growth factor) is established by observing the time from the loading dose to recurrence of the disease. The patient will come to control every four weeks to establish this interval. Second, the patient will receive injections at intervals that are two weeks shorter than the observed period. 2-3 injections are given before the next control. The control should be no later than six months ahead.
arm group label: Observe-and-Plan
intervention type: Other
intervention name: Treat-and-Extend
description: At the first control 4 weeks after the loading dose, the ophthalmologist assesses whether the macula is still wet or whether the macula is dry. In case of wet macula, the patient receives a new injection on the same day and a new control in 4 weeks. If the macula is dry, the patient will return in 2 weeks for the next injection, ie the injection interval is extended from 4 to 6 weeks.
Patients will be controlled every time they are to receive an intravitreal injection. If the macula is dry, the injection interval will be extended by 2 weeks and if the macula is wet the interval is shortened by 2 weeks. The shortest interval will be 4 weeks.
arm group label: Treat-and-Extend
other name: Standard treatment
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Dordi Austeng, MD PhD
role: Principal Investigator
affiliation: Norwegian University of Science and Technology, Fac MH, INB
last name: Marit Fagerli, MD
role: Study Director
affiliation: Clinic of Ear-Nose-Throat, Eye and Maxillofacial Surgery, St. Olavs Hospital
last name: Jorunn Helbostad, Professor
role: Study Director
affiliation: Norwegian University of Science and Technology, Fac MH, INB
last name: Margrete Sætre Hanssen, MD
phone: +47 91871727
email: margrete.saetre.hanssen@ntnu.no
last name: Dordi Austeng, MD PhD
email: dordi.austeng@ntnu.no
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Norway
citation: Mantel I, Niderprim SA, Gianniou C, Deli A, Ambresin A. Reducing the clinical burden of ranibizumab treatment for neovascular age-related macular degeneration using an individually planned regimen. Br J Ophthalmol. 2014 Sep;98(9):1192-6. doi: 10.1136/bjophthalmol-2013-304556. Epub 2014 Apr 10.
PMID: 24729031
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Wet Macular Degeneration
sharing ipd: Yes
ipd description: There is a plan to make IPD that underlie results in a publication and related data dictionaries available to other researchers.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The data will be available on request after publication.
ipd access criteria: The requests will be evaluated by the research group at the institute.