<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/NCT03290794</url>
  </required_header>
  <id_info>
    <org_study_id>19140</org_study_id>
    <nct_id>NCT03290794</nct_id>
  </id_info>
  <brief_title>Structured Post-marketing Surveillance to Collect the Safety Data of Intravitreal Aflibercept Injection (IVT-AFL) in Patients of Wet Age-related Macular Degeneration During Real World Clinical Practice</brief_title>
  <official_title>Structured Post-marketing Surveillance to Collect the Safety Data of Intravitreal Aflibercept Injection (IVT-AFL) in Patients of Wet Age-related Macular Degeneration During Real World Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</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>
      The proposed regulatory post-marketing surveillance (PMS) study will be planned to collect&#xD;
      the safety data of aflibercept intravitreal injection in patients with wet Age-related&#xD;
      Macular Degeneration (AMD) in real-life treatment practice&#xD;
&#xD;
      The primary objective is:&#xD;
&#xD;
      - To collect safety data in wet AMD patients treated with intravitreal aflibercept injection&#xD;
&#xD;
      The secondary objective is:&#xD;
&#xD;
      - To determine how disease activity is monitored including type and frequency of ocular tests&#xD;
      and frequency of injections&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be multicenter, observational, prospective, single arm, post marketing&#xD;
      surveillance study of intravitreal aflibercept injection in wet AMD patients in routine&#xD;
      clinical practice and real-life conditions without any protocol mandated interventions.&#xD;
&#xD;
      Approximately 100 wet AMD patients from up to ten ophthalmology clinics across India will be&#xD;
      enrolled in this study. Each study site will be requested to enroll approximately 10&#xD;
      patients, however, the sites will be asked to enrolled additional patients in case of failure&#xD;
      to enroll 10 patients by other site to complete the recruitment of approximately 100&#xD;
      patients.&#xD;
&#xD;
      Patients will be observed for maximum period of 6 months after the start of intravitreal&#xD;
      aflibercept treatment. The observation period should cover the entire period from initial&#xD;
      visit to the last follow-up visit at six months or withdrawal of consent, or the patient is&#xD;
      lost to follow up (whatever is earliest).&#xD;
&#xD;
      The study site will be asked to enroll into the study all consecutive patients with wet AMD&#xD;
      for whom the decision has been made to treat with intravitreal aflibercept injection and&#xD;
      patients agrees to sign informed consent form for data collection purpose.&#xD;
&#xD;
      Any switch to another therapy or initiated administration of other anti-VEGF (Vascular&#xD;
      Endothelial Growth Factor) injection in fellow eye or the discontinuation of treatment with&#xD;
      IVT-AFL before the 6 month implies the end of the observation period. However, the safety&#xD;
      follow-up will continue at least 30 days after last intravitreal aflibercept injection or in&#xD;
      case of the discontinuation of treatment with IVT-AFL or till the patient switch the&#xD;
      treatment from IVT-AFL and received other anti-VEGF injection before the 6 month observation&#xD;
      period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Actual">May 26, 2023</completion_date>
  <primary_completion_date type="Actual">November 25, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of reported ocular and non-ocular adverse events during observation period</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>unilateral / bilateral treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of reported ocular and non-ocular adverse events during observation period</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>unilateral / bilateral treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type of ocular tests undertaken</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>e.g. Visual acuity, ocular computed tomography, indocyanine angiography, Angiography, Fundus photography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interval between ocular test</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Date of ocular test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Date of aflibercept injections</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Date of aflibercept injections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Injection dose</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Injection dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interval (days) between aflibercept injections</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>During observation periods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of monitoring / clinic visits</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Frequency of monitoring / clinic visits</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Wet Age-related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Decision to treat with intravitreal aflibercept for wet AMD</arm_group_label>
    <description>Adult patients with a diagnosis of wet AMD, as an indication approved by the local health authorities for use with intravitreal aflibercept.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aflibercept (Eylea, BAY86-5321)</intervention_name>
    <description>Intravitreal Aflibercept as prescribed by the treating Physician</description>
    <arm_group_label>Decision to treat with intravitreal aflibercept for wet AMD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients previously treated with any systemic or other intravitreal anti-VEGF treatment&#xD;
        will be included in this study after the window period of 30 days to avoid the risks of&#xD;
        unknown additive effects that might be associated with previous anti-VEGF treatments .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Decision to treat with intravitreal aflibercept injection prior to patient enrolment&#xD;
             as per the treating ophthalmologist's routine clinical practice.&#xD;
&#xD;
          -  Adult patients with a diagnosis of wet AMD, as an indication approved by the local&#xD;
             health authorities (DCGI) for use with intravitreal aflibercept injection.&#xD;
&#xD;
          -  Patient or legal delegate signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in a clinical trial of an investigational agent within 30 days.&#xD;
&#xD;
          -  Patients receiving other anti-VEGF agent in fellow eye.&#xD;
&#xD;
          -  Contraindications according to the local prescribing information.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Many Locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <link>
    <url>http://clinicaltrials.bayer.com/</url>
    <description>Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2023</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>Macular Degeneration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aflibercept</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access.&#xD;
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.&#xD;
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.</ipd_description>
  </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/NCT03290794
org study id: 19140
nct id: NCT03290794
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed regulatory post-marketing surveillance (PMS) study will be planned to collect
      the safety data of aflibercept intravitreal injection in patients with wet Age-related
      Macular Degeneration (AMD) in real-life treatment practice

      The primary objective is:

      - To collect safety data in wet AMD patients treated with intravitreal aflibercept injection

      The secondary objective is:

      - To determine how disease activity is monitored including type and frequency of ocular tests
      and frequency of injections
The study will be multicenter, observational, prospective, single arm, post marketing
      surveillance study of intravitreal aflibercept injection in wet AMD patients in routine
      clinical practice and real-life conditions without any protocol mandated interventions.

      Approximately 100 wet AMD patients from up to ten ophthalmology clinics across India will be
      enrolled in this study. Each study site will be requested to enroll approximately 10
      patients, however, the sites will be asked to enrolled additional patients in case of failure
      to enroll 10 patients by other site to complete the recruitment of approximately 100
      patients.

      Patients will be observed for maximum period of 6 months after the start of intravitreal
      aflibercept treatment. The observation period should cover the entire period from initial
      visit to the last follow-up visit at six months or withdrawal of consent, or the patient is
      lost to follow up (whatever is earliest).

      The study site will be asked to enroll into the study all consecutive patients with wet AMD
      for whom the decision has been made to treat with intravitreal aflibercept injection and
      patients agrees to sign informed consent form for data collection purpose.

      Any switch to another therapy or initiated administration of other anti-VEGF (Vascular
      Endothelial Growth Factor) injection in fellow eye or the discontinuation of treatment with
      IVT-AFL before the 6 month implies the end of the observation period. However, the safety
      follow-up will continue at least 30 days after last intravitreal aflibercept injection or in
      case of the discontinuation of treatment with IVT-AFL or till the patient switch the
      treatment from IVT-AFL and received other anti-VEGF injection before the 6 month observation
      period.
observational model: Other
time perspective: Prospective
measure: Frequency of reported ocular and non-ocular adverse events during observation period
time frame: Up to 6 months
description: unilateral / bilateral treatment
measure: Percentage of reported ocular and non-ocular adverse events during observation period
time frame: Up to 6 months
description: unilateral / bilateral treatment
measure: Type of ocular tests undertaken
time frame: Up to 6 months
description: e.g. Visual acuity, ocular computed tomography, indocyanine angiography, Angiography, Fundus photography
measure: Interval between ocular test
time frame: Up to 6 months
description: Date of ocular test
measure: Date of aflibercept injections
time frame: Up to 6 months
description: Date of aflibercept injections
measure: Injection dose
time frame: Up to 6 months
description: Injection dose
measure: Interval (days) between aflibercept injections
time frame: Up to 6 months
description: During observation periods
measure: Frequency of monitoring / clinic visits
time frame: Up to 6 months
description: Frequency of monitoring / clinic visits
arm group label: Decision to treat with intravitreal aflibercept for wet AMD
description: Adult patients with a diagnosis of wet AMD, as an indication approved by the local health authorities for use with intravitreal aflibercept.
intervention type: Drug
intervention name: Aflibercept (Eylea, BAY86-5321)
description: Intravitreal Aflibercept as prescribed by the treating Physician
arm group label: Decision to treat with intravitreal aflibercept for wet AMD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: India
url: http://clinicaltrials.bayer.com/
description: Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Aflibercept
sharing ipd: No
ipd description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.