<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/NCT01666236</url>
  </required_header>
  <id_info>
    <org_study_id>CBPD952ABR01T</org_study_id>
    <nct_id>NCT01666236</nct_id>
  </id_info>
  <brief_title>Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy</brief_title>
  <official_title>Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study the effectiveness of the treatment detachment of retinal pigment epithelium secondary&#xD;
      to polypoidal choroidal vasculopathy. Efficacy will be assessed by regression of polyp area&#xD;
      after twelve months, compared to baseline. Treatment under study is a triple therapy with: 1)&#xD;
      reduced-fluence photodynamic therapy (PDT), 2) intravitreal (IVT) triamcinolone and, 3) IVT&#xD;
      ranibizumab, for the treatment of detachment of the retinal pigment epithelium (PED)&#xD;
      secondary to Polypoidal Choroidal Vasculopathy (PCV).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of resources&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2014</completion_date>
  <primary_completion_date type="Anticipated">September 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Auxiliary Exams - Optical Coherency Tomography (OCT)</measure>
    <time_frame>12 months after first procedure</time_frame>
    <description>Optical Coherency Tomography (OCT): To Assess the Retinal Thickness using the ETDRS thickness profile and to evaluate the regression of the pigment epithelium detachment.&#xD;
The Auxiliary exams are done at the Baseline, 10 days after the procedure and every 30 days until the end of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Auxiliary Exams - Indocyanine green angiography (ICGA)</measure>
    <time_frame>12 months after first procedure</time_frame>
    <description>Indocyanine green angiography (ICGA): To Evaluate the polyp lesions regression&#xD;
The Auxiliary exams are done at the Baseline, 10 days after the procedure and every 30 days until the end of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Auxiliary Exams - Fluorescein Angiography (FA)</measure>
    <time_frame>12 months after first procedure</time_frame>
    <description>Fluorescein Angiography (FA): To Evaluate subretinal neovascularization&#xD;
The Auxiliary exams are done at the Baseline, 10 days after the procedure and every 30 days until the end of the study.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Choroidal Neovascularization</condition>
  <condition>Retinal Pigment Epithelial Detachment</condition>
  <arm_group>
    <arm_group_label>Triple Therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The treatment (single group) will be treated with reduced-fluence Photodynamic Therapy (Visudyne -Verteporfin infused over 10 minutes at a dose of 6mg/m2 and following by activating light [wavelength of 689 nm] applied 15 minutes after the start of infusion with a light dose of either 25 J/cm2 for 83 seconds), followed by an Intra-vitreous triamcinolone (4mg/0.1ml) on the same day.&#xD;
After 10 days, patients will be subjected to an injection of Intra-vitreous ranibizumab (0.5 mg/0.05 ml). After this first injection, Intra-vitreous ranibizumab will be repeated twice, on a monthly basis, for a total of three injections</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Triple Therapy</intervention_name>
    <description>The treatment (single group) will be treated with reduced-fluence Photodynamic Therapy (Visudyne -Verteporfin infused over 10 minutes at a dose of 6mg/m2 and following by activating light [wavelength of 689 nm] applied 15 minutes after the start of infusion with a light dose of either 25 J/cm2 for 83 seconds), followed by an Intra-vitreous triamcinolone (4mg/0.1ml) on the same day.&#xD;
After 10 days, patients will be subjected to an injection of Intra-vitreous ranibizumab (0.5 mg/0.05 ml). After this first injection, Intra-vitreous ranibizumab will be repeated twice, on a monthly basis, for a total of three injections</description>
    <arm_group_label>Triple Therapy</arm_group_label>
    <other_name>Verteporfin</other_name>
    <other_name>Ranibizumab</other_name>
    <other_name>Triamcinolone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with PCV associated with PED near the polypoidal lesion recently diagnosed,&#xD;
             documented by FA, ICGA and OCT.&#xD;
&#xD;
          -  Visual acuity between 20/40 and 20/400.&#xD;
&#xD;
          -  Patients older than 50 years (both genders).&#xD;
&#xD;
          -  Women must be postmenopausal for at least 12 months or surgically sterile.&#xD;
&#xD;
          -  No previous treatment in the study eye.&#xD;
&#xD;
          -  Accept and sign the informed consent.&#xD;
&#xD;
          -  No condition that prevents the monitoring of the patient for one year.&#xD;
&#xD;
          -  Transparent ocular media and adequate pupillary dilation to allow good images of the&#xD;
             fundus.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blepharitis or external eye infection.&#xD;
&#xD;
          -  Allergy to ranibizumab, verteporfin, triamcinolone, fluorescein or indocyanine green.&#xD;
&#xD;
          -  Patients unable to provide informed consent.&#xD;
&#xD;
          -  Concomitant ocular disease that impairs visual acuity.&#xD;
&#xD;
          -  Any intraocular condition (such as cataract or Proliferative Diabetic Retinopathy) in&#xD;
             the study eye, in the opinion of the investigator, could require surgery or medication&#xD;
             during the follow-up (1 year).&#xD;
&#xD;
          -  Active intraocular inflammation.&#xD;
&#xD;
          -  Patients with Glaucoma and with ocular hypertension (IOP &gt; 25mmHg).&#xD;
&#xD;
          -  Premenopausal women. Pregnancy or lactation.&#xD;
&#xD;
          -  Effective treatment for active systemic infection or history of recurrent infection.&#xD;
&#xD;
          -  Evidence of concomitant disease (cardiovascular, neurological, pulmonary, renal,&#xD;
             hepatic, endocrine or gastrointestinal) uncontrolled.&#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>Pedro Paulo O Bonomo, phD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Federal de São Paulo - Escola Paulista de Medicina</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>04038-034</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>1. Bessho H, Honda S, Imai H, Negi B. Natural Course and Funduscopic Findings of Polypoidal Choroidal Vasculopathy in a Japanese Population Over 1 Year of Follow-up. Retina 2011; X: 1-5. 2. Uyama M, Wada M, Nagai Y, Matsubara T, Matsunaga H, Fukushima I, Takahashi K, Matsumura AM. Polypoidal Choroidal Vasculopathy: Natural History. Am J Ophthalmol 2002 May;133(5):639-648. 3. Ruamviboonsuk P, Tadarati M, Vanichvaranont S, Hanutsaha P, Pokawattana N. Photodynamic therapy combined with ranibizumab for polypoidal choroidal vasculopathy: results of a 1-year preliminary study. Br J Ophthalmol 2010;94:1045-1051. 4. Hikichi T, Ohtsuka H, Higuchi M, Matsushita T, Ariga H, Kosaka S, Matsushita R, Takami K. Improvement of Angiographic Findings of Polypoidal Choroidal Vasculopathy After Intravitreal Injection of Ranibizumab Monthly for 3 Months. Am J Ophthalmol 2010 Nov;150(5):674-682. 5. Kovacs KD, Quirk MT, Kinoshita T, Gautam S, Ceron OM, Murtha TJ, Arroyo JG. A retrospective analysis of triple combination therapy with intravitreal bevacizumab, posterior sub-tenon's triamcinolone acetonide, and low-fluence verteporfin photodynamic therapy in patients with neovascular age-related macular degeneration. Retina 2011 Mar;31(3):446-52. 6. Becerra EM, Morescalchi F, Gandolfo F, Danzi P, Nascimbeni G, Arcidiacono B, Semeraro F. Clinical evidence of intravitreal triamcinolone acetonide in the management of age-related macular degeneration. Curr Drug Targets. 2011 Feb;12(2):149-72. 7. Hajouli N, Hiesch A, Quintyn JC. Triple therapy for the treatment of choroidal neovascularization with pigment epithelium detachment in age-related macular degeneration. J Fr Ophtalmol. 2010 Sep;33(7):487-92. 8. Tao Y, Jonas JB. Intravitreal bevacizumab combined with intravitreal triamcinolone for therapy-resistant exudative age-related macular degeneration. J Ocul Pharmacol Ther. 2010 Apr;26(2):207-12.</citation>
  </results_reference>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>August 11, 2015</last_update_submitted>
  <last_update_submitted_qc>August 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Dr. Pedro Paulo de Oliveira Bonomo</investigator_full_name>
    <investigator_title>phD</investigator_title>
  </responsible_party>
  <keyword>Age-Related Macular Degeneration</keyword>
  <keyword>Pigment Epithelial Detachment</keyword>
  <keyword>Polypoidal Choroidal Vasculopathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Choroidal Neovascularization</mesh_term>
    <mesh_term>Polypoidal Choroidal Vasculopathy</mesh_term>
    <mesh_term>Retinal Detachment</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Neovascularization, Pathologic</mesh_term>
    <mesh_term>Dissociative Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Ranibizumab</mesh_term>
    <mesh_term>Verteporfin</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/NCT01666236
org study id: CBPD952ABR01T
nct id: NCT01666236
lead sponsor: 
collaborator: 
has dmc: No
Study the effectiveness of the treatment detachment of retinal pigment epithelium secondary
      to polypoidal choroidal vasculopathy. Efficacy will be assessed by regression of polyp area
      after twelve months, compared to baseline. Treatment under study is a triple therapy with: 1)
      reduced-fluence photodynamic therapy (PDT), 2) intravitreal (IVT) triamcinolone and, 3) IVT
      ranibizumab, for the treatment of detachment of the retinal pigment epithelium (PED)
      secondary to Polypoidal Choroidal Vasculopathy (PCV).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Auxiliary Exams - Optical Coherency Tomography (OCT)
time frame: 12 months after first procedure
description: Optical Coherency Tomography (OCT): To Assess the Retinal Thickness using the ETDRS thickness profile and to evaluate the regression of the pigment epithelium detachment.
The Auxiliary exams are done at the Baseline, 10 days after the procedure and every 30 days until the end of the study.
measure: Auxiliary Exams - Indocyanine green angiography (ICGA)
time frame: 12 months after first procedure
description: Indocyanine green angiography (ICGA): To Evaluate the polyp lesions regression
The Auxiliary exams are done at the Baseline, 10 days after the procedure and every 30 days until the end of the study.
measure: Auxiliary Exams - Fluorescein Angiography (FA)
time frame: 12 months after first procedure
description: Fluorescein Angiography (FA): To Evaluate subretinal neovascularization
The Auxiliary exams are done at the Baseline, 10 days after the procedure and every 30 days until the end of the study.
arm group label: Triple Therapy
arm group type: Other
description: The treatment (single group) will be treated with reduced-fluence Photodynamic Therapy (Visudyne -Verteporfin infused over 10 minutes at a dose of 6mg/m2 and following by activating light [wavelength of 689 nm] applied 15 minutes after the start of infusion with a light dose of either 25 J/cm2 for 83 seconds), followed by an Intra-vitreous triamcinolone (4mg/0.1ml) on the same day.
After 10 days, patients will be subjected to an injection of Intra-vitreous ranibizumab (0.5 mg/0.05 ml). After this first injection, Intra-vitreous ranibizumab will be repeated twice, on a monthly basis, for a total of three injections
intervention type: Other
intervention name: Triple Therapy
description: The treatment (single group) will be treated with reduced-fluence Photodynamic Therapy (Visudyne -Verteporfin infused over 10 minutes at a dose of 6mg/m2 and following by activating light [wavelength of 689 nm] applied 15 minutes after the start of infusion with a light dose of either 25 J/cm2 for 83 seconds), followed by an Intra-vitreous triamcinolone (4mg/0.1ml) on the same day.
After 10 days, patients will be subjected to an injection of Intra-vitreous ranibizumab (0.5 mg/0.05 ml). After this first injection, Intra-vitreous ranibizumab will be repeated twice, on a monthly basis, for a total of three injections
arm group label: Triple Therapy
other name: Verteporfin
other name: Ranibizumab
other name: Triamcinolone
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Pedro Paulo O Bonomo, phD
role: Principal Investigator
affiliation: Federal University of São Paulo
facility: 
country: Brazil
citation: 1. Bessho H, Honda S, Imai H, Negi B. Natural Course and Funduscopic Findings of Polypoidal Choroidal Vasculopathy in a Japanese Population Over 1 Year of Follow-up. Retina 2011; X: 1-5. 2. Uyama M, Wada M, Nagai Y, Matsubara T, Matsunaga H, Fukushima I, Takahashi K, Matsumura AM. Polypoidal Choroidal Vasculopathy: Natural History. Am J Ophthalmol 2002 May;133(5):639-648. 3. Ruamviboonsuk P, Tadarati M, Vanichvaranont S, Hanutsaha P, Pokawattana N. Photodynamic therapy combined with ranibizumab for polypoidal choroidal vasculopathy: results of a 1-year preliminary study. Br J Ophthalmol 2010;94:1045-1051. 4. Hikichi T, Ohtsuka H, Higuchi M, Matsushita T, Ariga H, Kosaka S, Matsushita R, Takami K. Improvement of Angiographic Findings of Polypoidal Choroidal Vasculopathy After Intravitreal Injection of Ranibizumab Monthly for 3 Months. Am J Ophthalmol 2010 Nov;150(5):674-682. 5. Kovacs KD, Quirk MT, Kinoshita T, Gautam S, Ceron OM, Murtha TJ, Arroyo JG. A retrospective analysis of triple combination therapy with intravitreal bevacizumab, posterior sub-tenon's triamcinolone acetonide, and low-fluence verteporfin photodynamic therapy in patients with neovascular age-related macular degeneration. Retina 2011 Mar;31(3):446-52. 6. Becerra EM, Morescalchi F, Gandolfo F, Danzi P, Nascimbeni G, Arcidiacono B, Semeraro F. Clinical evidence of intravitreal triamcinolone acetonide in the management of age-related macular degeneration. Curr Drug Targets. 2011 Feb;12(2):149-72. 7. Hajouli N, Hiesch A, Quintyn JC. Triple therapy for the treatment of choroidal neovascularization with pigment epithelium detachment in age-related macular degeneration. J Fr Ophtalmol. 2010 Sep;33(7):487-92. 8. Tao Y, Jonas JB. Intravitreal bevacizumab combined with intravitreal triamcinolone for therapy-resistant exudative age-related macular degeneration. J Ocul Pharmacol Ther. 2010 Apr;26(2):207-12.
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Dr. Pedro Paulo de Oliveira Bonomo
investigator title: phD
mesh term: Choroidal Neovascularization
mesh term: Polypoidal Choroidal Vasculopathy
mesh term: Retinal Detachment
mesh term: Vascular Diseases
mesh term: Neovascularization, Pathologic
mesh term: Dissociative Disorders
mesh term: Triamcinolone
mesh term: Ranibizumab
mesh term: Verteporfin