<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/NCT02979665</url>
  </required_header>
  <id_info>
    <org_study_id>105570</org_study_id>
    <nct_id>NCT02979665</nct_id>
  </id_info>
  <brief_title>Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema</brief_title>
  <official_title>A Clinico-Pathological Study of the Structural and Functional Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      anti-VEGF therapy is an established method to control leakage and abnormal growth of retinal&#xD;
      blood vessels. Questions on the long-term effect on the retina, intraocular pressure and on&#xD;
      the overall retinal perfusion from these treatments remain to be answered. The purpose of the&#xD;
      study was to evaluate changes in the retina following anti-VEGF treatment over time, using&#xD;
      structural and functional diagnostic tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetic retinopathy (DR) causes changes in the capillaries that nourish the retina. Two&#xD;
      treatments clinically used for DR are laser photocoagulation to reduce the angiogenic drive&#xD;
      by knocking off metabolically active retina and anti-VEGF drugs for diabetic macular edema&#xD;
      (DME). DME affects approximately 2.5% of the nearly 2.4 million Canadians with diabetes, or&#xD;
      approximately 60,000 Canadians, making it a major cause of adult-onset vision loss. DME&#xD;
      occurs when blood vessels in the retina of diabetic patients become leaky resulting in&#xD;
      unwanted fluid accumulation in the center of vision known as the macula. If not treated, this&#xD;
      can lead to blindness. Originally used in the treatment of age-related macular degeneration&#xD;
      (AMD), anti-VEGF drugs are increasingly used to control leakage and abnormal growth of&#xD;
      retinal blood vessels. Numerous questions have emerged following the usage of anti-VEGF&#xD;
      medications in the eye such as their long-term effects of these drugs on intraocular pressure&#xD;
      and on the overall retinal perfusion. By recruiting DR patients requiring anti-VEGF treatment&#xD;
      for DME, this study will answer whether long-term usage of anti-VEGF will result in&#xD;
      structural and functional changes to the retina.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Effects of anti-VEGF drugs on intraocular pressure (mmHg)</measure>
    <time_frame>2 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effects of anti-VEGF drugs on macular thickness (um)</measure>
    <time_frame>2 year</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">51</enrollment>
  <condition>Diabetic Macular Edema</condition>
  <arm_group>
    <arm_group_label>Ranibizumab Ophthalmic</arm_group_label>
    <description>DME consults requiring anti-VEGF treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>DME consults not requiring anti-VEGF</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranibizumab Ophthalmic</intervention_name>
    <description>Ranibizumab (trade name Lucentis among others) is a monoclonal antibody fragment (Fab) created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that has been approved to treat the &quot;wet&quot; type of age-related macular degeneration (AMD, also ARMD), a common form of age-related vision loss and diabetic macular edema (DME).</description>
    <arm_group_label>Ranibizumab Ophthalmic</arm_group_label>
    <other_name>Lucentis</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        DR consults referred to the Ivey Eye Institute and requiring anti-VEGF injections in at&#xD;
        least one eye due to DME will be recruited into the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DME patients&#xD;
&#xD;
          -  Require anti-VEGF injections in at least one eye&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Advanced lens opacity or cataract that could affect diagnostic testing&#xD;
&#xD;
          -  Prior retinal treatment (PRP, focal laser or surgery within 6 months of participation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cindy Hutnik, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Joseph's Health Care London</affiliation>
  </overall_official>
  <link>
    <url>http://www.diabetes.ca/diabetes-and-you/complications/eye-damage-diabetic-retinopathy</url>
    <description>Canadian Diabetes Association. Eye Damage (Diabetic Retinopathy).</description>
  </link>
  <reference>
    <citation>Simo R, Hernandez C. Intravitreous anti-VEGF for diabetic retinopathy: hopes and fears for a new therapeutic strategy. Diabetologia. 2008 Sep;51(9):1574-80. doi: 10.1007/s00125-008-0989-9. Epub 2008 Apr 11.</citation>
    <PMID>18404258</PMID>
  </reference>
  <reference>
    <citation>Osaadon P, Fagan XJ, Lifshitz T, Levy J. A review of anti-VEGF agents for proliferative diabetic retinopathy. Eye (Lond). 2014 May;28(5):510-20. doi: 10.1038/eye.2014.13. Epub 2014 Feb 14.</citation>
    <PMID>24525867</PMID>
  </reference>
  <reference>
    <citation>Singh RS, Kim JE. Ocular hypertension following intravitreal anti-vascular endothelial growth factor agents. Drugs Aging. 2012 Dec;29(12):949-56. doi: 10.1007/s40266-012-0031-2.</citation>
    <PMID>23179897</PMID>
  </reference>
  <reference>
    <citation>Mathalone N, Arodi-Golan A, Sar S, Wolfson Y, Shalem M, Lavi I, Geyer O. Sustained elevation of intraocular pressure after intravitreal injections of bevacizumab in eyes with neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2012 Oct;250(10):1435-40. doi: 10.1007/s00417-012-1981-0. Epub 2012 Mar 21.</citation>
    <PMID>22434210</PMID>
  </reference>
  <reference>
    <citation>Neubauer AS, Kook D, Haritoglou C, Priglinger SG, Kampik A, Ulbig MW, Ceklic L. Bevacizumab and retinal ischemia. Ophthalmology. 2007 Nov;114(11):2096. doi: 10.1016/j.ophtha.2007.05.057. No abstract available.</citation>
    <PMID>17980746</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>April 30, 2019</last_update_submitted>
  <last_update_submitted_qc>April 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2019</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 Edema</mesh_term>
    <mesh_term>Edema</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/NCT02979665
org study id: 105570
nct id: NCT02979665
lead sponsor: 
has dmc: Yes
anti-VEGF therapy is an established method to control leakage and abnormal growth of retinal
      blood vessels. Questions on the long-term effect on the retina, intraocular pressure and on
      the overall retinal perfusion from these treatments remain to be answered. The purpose of the
      study was to evaluate changes in the retina following anti-VEGF treatment over time, using
      structural and functional diagnostic tests.
Diabetic retinopathy (DR) causes changes in the capillaries that nourish the retina. Two
      treatments clinically used for DR are laser photocoagulation to reduce the angiogenic drive
      by knocking off metabolically active retina and anti-VEGF drugs for diabetic macular edema
      (DME). DME affects approximately 2.5% of the nearly 2.4 million Canadians with diabetes, or
      approximately 60,000 Canadians, making it a major cause of adult-onset vision loss. DME
      occurs when blood vessels in the retina of diabetic patients become leaky resulting in
      unwanted fluid accumulation in the center of vision known as the macula. If not treated, this
      can lead to blindness. Originally used in the treatment of age-related macular degeneration
      (AMD), anti-VEGF drugs are increasingly used to control leakage and abnormal growth of
      retinal blood vessels. Numerous questions have emerged following the usage of anti-VEGF
      medications in the eye such as their long-term effects of these drugs on intraocular pressure
      and on the overall retinal perfusion. By recruiting DR patients requiring anti-VEGF treatment
      for DME, this study will answer whether long-term usage of anti-VEGF will result in
      structural and functional changes to the retina.
observational model: Cohort
time perspective: Prospective
measure: Effects of anti-VEGF drugs on intraocular pressure (mmHg)
time frame: 2 year
measure: Effects of anti-VEGF drugs on macular thickness (um)
time frame: 2 year
arm group label: Ranibizumab Ophthalmic
description: DME consults requiring anti-VEGF treatment
arm group label: Control
description: DME consults not requiring anti-VEGF
intervention type: Drug
intervention name: Ranibizumab Ophthalmic
description: Ranibizumab (trade name Lucentis among others) is a monoclonal antibody fragment (Fab) created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that has been approved to treat the "wet" type of age-related macular degeneration (AMD, also ARMD), a common form of age-related vision loss and diabetic macular edema (DME).
arm group label: Ranibizumab Ophthalmic
other name: Lucentis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cindy Hutnik, MD, PhD
role: Principal Investigator
affiliation: St. Joseph's Health Care London
url: http://www.diabetes.ca/diabetes-and-you/complications/eye-damage-diabetic-retinopathy
description: Canadian Diabetes Association. Eye Damage (Diabetic Retinopathy).
citation: Simo R, Hernandez C. Intravitreous anti-VEGF for diabetic retinopathy: hopes and fears for a new therapeutic strategy. Diabetologia. 2008 Sep;51(9):1574-80. doi: 10.1007/s00125-008-0989-9. Epub 2008 Apr 11.
PMID: 18404258
citation: Osaadon P, Fagan XJ, Lifshitz T, Levy J. A review of anti-VEGF agents for proliferative diabetic retinopathy. Eye (Lond). 2014 May;28(5):510-20. doi: 10.1038/eye.2014.13. Epub 2014 Feb 14.
PMID: 24525867
citation: Singh RS, Kim JE. Ocular hypertension following intravitreal anti-vascular endothelial growth factor agents. Drugs Aging. 2012 Dec;29(12):949-56. doi: 10.1007/s40266-012-0031-2.
PMID: 23179897
citation: Mathalone N, Arodi-Golan A, Sar S, Wolfson Y, Shalem M, Lavi I, Geyer O. Sustained elevation of intraocular pressure after intravitreal injections of bevacizumab in eyes with neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2012 Oct;250(10):1435-40. doi: 10.1007/s00417-012-1981-0. Epub 2012 Mar 21.
PMID: 22434210
citation: Neubauer AS, Kook D, Haritoglou C, Priglinger SG, Kampik A, Ulbig MW, Ceklic L. Bevacizumab and retinal ischemia. Ophthalmology. 2007 Nov;114(11):2096. doi: 10.1016/j.ophtha.2007.05.057. No abstract available.
PMID: 17980746
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Edema
mesh term: Ranibizumab