<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/NCT01676506</url>
  </required_header>
  <id_info>
    <org_study_id>GB-1000-LC</org_study_id>
    <nct_id>NCT01676506</nct_id>
  </id_info>
  <brief_title>Genetic Polymorphisms in Ranibizumab Treatment in Wet Age-Related Macular Degeneration (AMD)</brief_title>
  <official_title>The Impact of Genetic Polymorphisms on Ranibizumab Treatment Outcomes in Wet Age-Related Macular Degeneration (AMD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Russian Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Russian Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Genetic factors of an individual patient may have an impact on Ranibizumab (Lucentis)&#xD;
      treatment outcome in patients with Wet Age-Related Macular Degeneration (AMD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Age-Related Macular Degeneration (AMD) is a disease that affects central part of the retina,&#xD;
      called macula, and is associated with progressive central vision loss. Moreover, AMD is known&#xD;
      to be a leading cause of blindness in developed countries. In wet form of AMD, new abnormal&#xD;
      blood vessels start to grow from the choroid towards the retina that leads to leakage from&#xD;
      these vessels and, in turn, to impaired retinal structure and rapid vision loss.&#xD;
&#xD;
      Genetic factors were found to be important in development of wet AMD. Our previous research&#xD;
      showed the association between some genetic polymorphisms and the risk of wet AMD as well as&#xD;
      with specific clinical features of the disease. At present, anti-vascular endothelial growth&#xD;
      factor (anti-VEGF) therapy with intravitreous ranibizumab (Lucentis) is considered to be the&#xD;
      most effective treatment for wet AMD. However, treatment outcomes may vary significantly from&#xD;
      improved vision to no effect. The aim of this research is to study how ranibizumab treatment&#xD;
      outcomes depend on genetic factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2011</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual acuity</measure>
    <time_frame>Baseline and month 3</time_frame>
    <description>Best corrected visual acuity will be assessed by standardized vision testing, early treatment diabetic retinopathy study (ETDRS) test.</description>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Age-Related Macular Degeneration</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranibizumab</intervention_name>
    <description>Intravitreal injections of 0.5mg/0.05 mL dosage, injected at months 0, 1, and 2.</description>
    <other_name>Lucentis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ranibizumab Injection</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be at least 50 years old&#xD;
&#xD;
          -  Neovascular age-related macular degeneration&#xD;
&#xD;
          -  CNV in the central part of the retina (macular is involved)&#xD;
&#xD;
          -  Active CNM (seen on fundus fluorescein angiography)&#xD;
&#xD;
          -  CNV activity is on one of the following: sub-retinal hemorrhage, sub-retinal lipid,&#xD;
             documented loss of 3 lines of vision during last 3 months&#xD;
&#xD;
          -  Visual acuity of between 20/40 and 20/300 (ETDRS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 50 years old&#xD;
&#xD;
          -  Patients with CNM not caused by AMD&#xD;
&#xD;
          -  Patients physically unable to tolerate intravenous fluorescein angiography&#xD;
&#xD;
          -  Patients with medically uncontrolled glaucoma&#xD;
&#xD;
          -  Patients with history of bronchial asthma, thrombophlebitis, polyvalent allergy,&#xD;
             cancer&#xD;
&#xD;
          -  Any intraocular surgery within 3 months in the study eye&#xD;
&#xD;
          -  Prior retinal or vitreous surgery including vitrectomy or scleral buckling&#xD;
&#xD;
          -  Any significant ocular disease other than AMD that has compromised or could compromise&#xD;
             vision in the study eye and confound analysis of the primary outcome&#xD;
&#xD;
          -  Individuals with physical or mental disabilities that prevent accurate vision testing&#xD;
&#xD;
          -  History of any laser treatment of CNV in study eye (laser photocoagulation or prior&#xD;
             photodynamic therapy), or anti-VEGF (ranibizumab or bevacizumab) in the past 2 years&#xD;
             in the study eye.&#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>Mariya Budzinskaya, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>State Research Institute of Eye Disease of Russian Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ekaterina Chikun, MD</last_name>
    <phone>0079160386679</phone>
    <email>kate_chi@inbox.ru</email>
  </overall_contact>
  <location>
    <facility>
      <name>State Research Institute of Eye Disease of Russian Academy of Medical Sciences</name>
      <address>
        <city>Moscow</city>
        <zip>119021</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mariya Budzinskaya, MD, PhD</last_name>
      <phone>0074992487686</phone>
      <email>m_budzinskaya@mail.ru</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>January 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>August 30, 2012</last_update_submitted>
  <last_update_submitted_qc>August 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Russian Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Ekaterina Chikun</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>Wet AMD</keyword>
  <keyword>genetic polymorphisms</keyword>
  <keyword>Ranibizumab</keyword>
  <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>Ranibizumab</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01676506
org study id: GB-1000-LC
nct id: NCT01676506
lead sponsor: 
has dmc: No
Genetic factors of an individual patient may have an impact on Ranibizumab (Lucentis)
      treatment outcome in patients with Wet Age-Related Macular Degeneration (AMD).
Age-Related Macular Degeneration (AMD) is a disease that affects central part of the retina,
      called macula, and is associated with progressive central vision loss. Moreover, AMD is known
      to be a leading cause of blindness in developed countries. In wet form of AMD, new abnormal
      blood vessels start to grow from the choroid towards the retina that leads to leakage from
      these vessels and, in turn, to impaired retinal structure and rapid vision loss.

      Genetic factors were found to be important in development of wet AMD. Our previous research
      showed the association between some genetic polymorphisms and the risk of wet AMD as well as
      with specific clinical features of the disease. At present, anti-vascular endothelial growth
      factor (anti-VEGF) therapy with intravitreous ranibizumab (Lucentis) is considered to be the
      most effective treatment for wet AMD. However, treatment outcomes may vary significantly from
      improved vision to no effect. The aim of this research is to study how ranibizumab treatment
      outcomes depend on genetic factors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual acuity
time frame: Baseline and month 3
description: Best corrected visual acuity will be assessed by standardized vision testing, early treatment diabetic retinopathy study (ETDRS) test.
intervention type: Drug
intervention name: Ranibizumab
description: Intravitreal injections of 0.5mg/0.05 mL dosage, injected at months 0, 1, and 2.
other name: Lucentis
intervention type: Procedure
intervention name: Ranibizumab Injection
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Mariya Budzinskaya, MD, PhD
role: Study Chair
affiliation: State Research Institute of Eye Disease of Russian Academy of Medical Sciences
last name: Ekaterina Chikun, MD
phone: 0079160386679
email: kate_chi@inbox.ru
facility: 
status: Recruiting
contact: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Russian Academy of Medical Sciences
investigator full name: Ekaterina Chikun
investigator title: Researcher
mesh term: Macular Degeneration
mesh term: Ranibizumab