<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/NCT01669447</url>
  </required_header>
  <id_info>
    <org_study_id>OSouza</org_study_id>
    <nct_id>NCT01669447</nct_id>
  </id_info>
  <brief_title>Evaluation of Changes in the Parameters of Optical Coherence Tomography After Intravitreal Injection of Lucentis</brief_title>
  <official_title>Assessment in Early Changes in the Parameters of Optical Coherence Tomography (OCT Spectral Domain) in Patients With Subfoveal Neovascular Membranes Related to Age After Treatment With a Single Intravitreal Injection of Lucentis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Osias Francisco de Souza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campinas, Brazil</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Significant difference in the parameter settings of early optical coherence tomography (OCT&#xD;
      spectal domain) in patients with subfoveal neovascular membrane realacionada age after&#xD;
      treatment with a single intravitreal injection of Lucentis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assessment in early changes in the parameters of optical coherence tomography (OCT spectral&#xD;
      domain) in patients with subfoveal neovascularization secondary to age-related degeneration&#xD;
      after treatment with a single intravitreal injection of Lucentis.&#xD;
&#xD;
      Age-related macular degeneration (AMD) leading cause of blindness over 50 years in developed&#xD;
      Western countries. Its prevalence increases with age affecting about 8.5 to 27.9% of the&#xD;
      population over 75 years. Its incidence has increased 30-40% in recent decades, in spite of&#xD;
      eye diseases such as cataracts and glaucoma, which reach the same population group, have&#xD;
      shown apparently reduced their records.&#xD;
&#xD;
      Although approximately 80% of patients with AMD have the neovascular form does not, the&#xD;
      neovascular form is responsible for almost 90% of severe visual loss resulting from AMD. It&#xD;
      creates great socioeconomic impact, becoming a public health problem.&#xD;
&#xD;
      Quantitative analysis of OCT has shown increasing clinical importance with the development of&#xD;
      anti-VEGF therapy to evaluate the outcome of the treatment of neovascular AMD.&#xD;
&#xD;
      Relatively few studies in AMD has been proposed to examine the correlation between the&#xD;
      morphological parameters of the OCT and BCVA in a systematic way.&#xD;
&#xD;
      It is important to assess the impact that different OCT parameters have on visual acuity as&#xD;
      early as 7 days after intravitreal injection of ranibizumab in patients with AMD to define&#xD;
      which of these parameters correlate better with the AV and prognosis. It is also unknown&#xD;
      which patients' perception of the effectiveness of treatment in early stage. For this&#xD;
      evaluation, we apply the visual function questionnaire (VFQ - 25) 1 and 7 days after&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">November 2012</primary_completion_date>
  <phase>Phase 4</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Degeneration of Macula and Posterior Pole</condition>
  <arm_group>
    <arm_group_label>ranibizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interventional study, prospective will be conducted in a single eye of twenty consecutive patients who will receive intravitreal ranibizumab for neovascular membrane active subfoveal choroidal active due to AMD and visual acuity of 20/40 and 20/320.&#xD;
To establish the presence of active neovascularization evaluated the presence of leakage seen on fluorescein angiography and fluid, as seen in optical coherence tomography (OCT), located both intra and subretinal, or below the retinal pigment epithelium.&#xD;
Treatment with ranibizumab will be offered after extensive Discussing the pathogenesis of AMD, the treatment alternatives, as well as the possible risks of treatment with ranibizumab. Term of consent shall be obtained prior to treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ranibizumab</intervention_name>
    <description>Interventional study, prospective will be conducted in a single eye of twenty consecutive patients who will receive intravitreal ranibizumab for neovascular membrane active subfoveal choroidal active due to AMD and visual acuity of 20/40 and 20/320.&#xD;
To establish the presence of active neovascularization evaluated the presence of leakage seen on fluorescein angiography and fluid, as seen in optical coherence tomography (OCT), located both intra and subretinal, or below the retinal pigment epithelium.&#xD;
Treatment with ranibizumab will be offered after extensive Discussing the pathogenesis of AMD, the treatment alternatives, as well as the possible risks of treatment with ranibizumab. Term of consent shall be obtained prior to treatment.</description>
    <arm_group_label>ranibizumab</arm_group_label>
    <other_name>LUCENTIS®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&gt; 50 years who signed the consent form BCAV of 20/40 20/320 (Snellen&#xD;
             equivalent determined using ETDRS)Have choroidal neovascularization associated with&#xD;
             AMD, have lesions involving the fovea assessed using fluorescein angiography and&#xD;
             fundus Background of subfoveal choroidal neovascularization from the recent&#xD;
             developments have constructive AMD disease, observed by the presence of blood,&#xD;
             decrease the AV recent or most recent increase in the diameter range of 10% or more.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant diseases or eye conditions eye disorders that may confound interpretation&#xD;
             of study results affecting visual acuity or require medical surgical interventions&#xD;
             during 30 days of the study period, including retinal vascular occlusion,retinal&#xD;
             detachment and macular hole. Eye Treatments with laser photocoagulation panretiniana&#xD;
             eye studied for 6 months or less or focal / grid photocoagulation in the eye studied&#xD;
             for less than 3 months of the entry into the study treatment with anti-angiogenic or&#xD;
             intravitreal steroids in the eye studied until 4 months before randomization Any&#xD;
             intraocular surgery on the eye studied until 3 months before History randomization&#xD;
             vitrectomy eye conditions studied in ocular studied eye requiring concomitant therapy&#xD;
             with corticosteroids oral or topical. Condition Treatment or systemic history of&#xD;
             disease, metabolic dysfunction, physical examination findings, or laboratory suspected&#xD;
             to cause disease or condition that contraindicates the use of study drugs, change the&#xD;
             interpretation of the study or place the patient in risk of complications from the&#xD;
             treatment. And intractable severe hypertension (diastolic blood pressure&gt; 160 mmHg or&#xD;
             diastolic&gt; 100 mmHg) Use of drugs known to be toxic to the lens, retina or optic nerve&#xD;
             including Deferoxamine, chloroquine, tamoxifen, fenotiazines, and ethambutol. Known&#xD;
             hypersensitivity to ranibizumab or its components prior Administrative Participation&#xD;
             of patients in studies clinical investigative drug (excluding vitamins and minerals)&#xD;
             at 6 months (or period corresponding to five half-lives of drug investigated is&#xD;
             greater) before randomization Failure to comply with study procedures or follow-up&#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>NICOLLE ALMEIDA, GRADUATE</last_name>
    <role>Study Director</role>
    <affiliation>CENTRO MÉDICO OFTALMOLÓGICO</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Osias Souza, PI</last_name>
    <role>Principal Investigator</role>
    <affiliation>CENTRO MEDICO OFTALMOLÓGICO</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Claudia Viana, graduate</last_name>
    <role>Study Chair</role>
    <affiliation>Centro Medico Oftalmológico</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>OSIAS SOUZA, PI</last_name>
    <phone>+55(19)97732770</phone>
    <email>osiasfs@uol.com.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>NICOLLE ALMEIDA, CO-PI</last_name>
    <phone>+55(19)96867216</phone>
    <email>nkaalmeida@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centro Médico Oftalmológico</name>
      <address>
        <city>Campinas</city>
        <state>SP</state>
        <zip>13092132</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <contact>
      <last_name>OSIAS SOUZA, PI</last_name>
      <phone>+55(19)97732770</phone>
      <email>osiasfs@uol.com.br</email>
    </contact>
    <contact_backup>
      <last_name>NICOLLE ALMEIDA, SUB-I</last_name>
      <phone>+55(19)96867216</phone>
      <email>nkaalmeida@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>OSIAS SOUZA, PI</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>NICOLLE ALMEIDA, GRADUATE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>August 20, 2012</last_update_submitted>
  <last_update_submitted_qc>August 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Campinas, Brazil</investigator_affiliation>
    <investigator_full_name>Osias Francisco de Souza</investigator_full_name>
    <investigator_title>PhD in Ophthalmology</investigator_title>
  </responsible_party>
  <keyword>dmri, mnvc, lucentis</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/NCT01669447
org study id: OSouza
nct id: NCT01669447
lead sponsor: 
has dmc: No
Significant difference in the parameter settings of early optical coherence tomography (OCT
      spectal domain) in patients with subfoveal neovascular membrane realacionada age after
      treatment with a single intravitreal injection of Lucentis.
Assessment in early changes in the parameters of optical coherence tomography (OCT spectral
      domain) in patients with subfoveal neovascularization secondary to age-related degeneration
      after treatment with a single intravitreal injection of Lucentis.

      Age-related macular degeneration (AMD) leading cause of blindness over 50 years in developed
      Western countries. Its prevalence increases with age affecting about 8.5 to 27.9% of the
      population over 75 years. Its incidence has increased 30-40% in recent decades, in spite of
      eye diseases such as cataracts and glaucoma, which reach the same population group, have
      shown apparently reduced their records.

      Although approximately 80% of patients with AMD have the neovascular form does not, the
      neovascular form is responsible for almost 90% of severe visual loss resulting from AMD. It
      creates great socioeconomic impact, becoming a public health problem.

      Quantitative analysis of OCT has shown increasing clinical importance with the development of
      anti-VEGF therapy to evaluate the outcome of the treatment of neovascular AMD.

      Relatively few studies in AMD has been proposed to examine the correlation between the
      morphological parameters of the OCT and BCVA in a systematic way.

      It is important to assess the impact that different OCT parameters have on visual acuity as
      early as 7 days after intravitreal injection of ranibizumab in patients with AMD to define
      which of these parameters correlate better with the AV and prognosis. It is also unknown
      which patients' perception of the effectiveness of treatment in early stage. For this
      evaluation, we apply the visual function questionnaire (VFQ - 25) 1 and 7 days after
      treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
arm group label: ranibizumab
arm group type: Experimental
description: Interventional study, prospective will be conducted in a single eye of twenty consecutive patients who will receive intravitreal ranibizumab for neovascular membrane active subfoveal choroidal active due to AMD and visual acuity of 20/40 and 20/320.
To establish the presence of active neovascularization evaluated the presence of leakage seen on fluorescein angiography and fluid, as seen in optical coherence tomography (OCT), located both intra and subretinal, or below the retinal pigment epithelium.
Treatment with ranibizumab will be offered after extensive Discussing the pathogenesis of AMD, the treatment alternatives, as well as the possible risks of treatment with ranibizumab. Term of consent shall be obtained prior to treatment.
intervention type: Biological
intervention name: ranibizumab
description: Interventional study, prospective will be conducted in a single eye of twenty consecutive patients who will receive intravitreal ranibizumab for neovascular membrane active subfoveal choroidal active due to AMD and visual acuity of 20/40 and 20/320.
To establish the presence of active neovascularization evaluated the presence of leakage seen on fluorescein angiography and fluid, as seen in optical coherence tomography (OCT), located both intra and subretinal, or below the retinal pigment epithelium.
Treatment with ranibizumab will be offered after extensive Discussing the pathogenesis of AMD, the treatment alternatives, as well as the possible risks of treatment with ranibizumab. Term of consent shall be obtained prior to treatment.
arm group label: ranibizumab
other name: LUCENTIS®
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: NICOLLE ALMEIDA, GRADUATE
role: Study Director
affiliation: CENTRO MÉDICO OFTALMOLÓGICO
last name: Osias Souza, PI
role: Principal Investigator
affiliation: CENTRO MEDICO OFTALMOLÓGICO
last name: Claudia Viana, graduate
role: Study Chair
affiliation: Centro Medico Oftalmológico
last name: OSIAS SOUZA, PI
phone: +55(19)97732770
email: osiasfs@uol.com.br
last name: NICOLLE ALMEIDA, CO-PI
phone: +55(19)96867216
email: nkaalmeida@gmail.com
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: University of Campinas, Brazil
investigator full name: Osias Francisco de Souza
investigator title: PhD in Ophthalmology
mesh term: Macular Degeneration
mesh term: Ranibizumab