<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/NCT02227745</url>
  </required_header>
  <id_info>
    <org_study_id>HJM 2296/14-R</org_study_id>
    <nct_id>NCT02227745</nct_id>
  </id_info>
  <brief_title>Efficacy of Dorzolamide as an Adjuvant After Focal Photocoagulation in Clinically Significant Macular Edema</brief_title>
  <official_title>Efficacy of Dorzolamide as an Adjuvant to Improve Visual Function After Focal Photocoagulation Treatment in Diabetic Patients With Clinically Significant Macular Edema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Juarez de Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Juarez de Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Photocoagulation is the standard treatment in the focal EMCS, disrupts vascular leakage and&#xD;
      allows the pigment epithelium remove the intraretinal fluid is effective in reducing the&#xD;
      incidence of visual loss but can reduce contrast sensitivity and retinal sensitivity, the&#xD;
      characteristics of the function can be reduced such as setting (location and stability) are&#xD;
      relevant to the quality of the patient's vision parameters, reading comprehension, especially&#xD;
      the ability, duration of diabetic macular edema, could have a significant impact on survival&#xD;
      and / or the functional reserve of the macular cells subjected to mechanical and toxic&#xD;
      stress-induced edema. It seems that in the treatment of patients with EMCS, photoreceptor&#xD;
      damage occurs as a recent phenomenon, and can precede neurodegeneration retinal photoreceptor&#xD;
      loss, whereby visual function can be decreased. An adjunctive treatment as Dorzolamide&#xD;
      facilitating effect helping resorption of intraretinal fluid through EPR and reduce adverse&#xD;
      events that is the loss of contrast sensitivity and retinal sensitivity, response time of&#xD;
      photocoagulation treatment could be reduced to the patient, because the rate of resorption of&#xD;
      intraretinal fluid is facilitated and thus the duration of the response, also could reduce&#xD;
      damage to vision caused by the inadequacies of the photoreceptors during the evolution of&#xD;
      macular edema avoiding moderate visual loss, there by increasing the quality of life in terms&#xD;
      of improving the quality of vision in diabetic patients. In addition to obtaining a specific&#xD;
      adjuvant treatment with photocoagulation is helpful for focal edema in diabetic and a new&#xD;
      level using dorzolamide in retina Dorzolamide as adjunctive therapy after focal&#xD;
      photocoagulation is more effective than placebo in improving visual function in patients with&#xD;
      diabetic macular edema&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients referred to ophthalmology for developing type 2 diabetes subspecialist&#xD;
      ophthalmologist evaluate the macula them by biomicroscopy, pupillary dilation, to detect&#xD;
      clinically significant macular edema. EMCS diagnosis is made according to ETDRS criteria, and&#xD;
      patients who were requested to submit fluorescein angiography.&#xD;
&#xD;
      Patients presenting with focal leakage on angiography were scheduled focal photocoagulation;&#xD;
      day focal photocoagulation is measured before the procedure Measurement of visual acuity,&#xD;
      visual acuity, refraction Measuring contrast sensitivity Measurement of retinal sensitivity&#xD;
      Measurement of Optical Coherence Tomography ophthalmoscopic review&#xD;
&#xD;
      Subsequently photocoagulation treatment was applied according to the guidelines of the ETDRS&#xD;
      (1-50 number of shots, shot diameter of 100 microns and 120-180 mW power) and the patient was&#xD;
      re-evaluated at 4 weeks, which will repeat the testing day photocoagulation.&#xD;
&#xD;
      The patient what the research project will be discussed, will be invited to participate, will&#xD;
      be read and informed consent was explained, questions and concerns will be clarified during&#xD;
      the study, and patients who agree to enter the study will be assigned so random treatment.&#xD;
&#xD;
      Patient 1 drop of topical drug in the treaty provided every 8 hours for 4 weeks eye is&#xD;
      placed, the drug provided will be needed for 4 weeks, plus a control sheet dose delivery will&#xD;
      be provided and shall be referenced again in April weeks later for evaluation:&#xD;
&#xD;
      After 4 weeks of topical treatment, evaluation from 8:00 to 11 pm will be the same from the&#xD;
      first date&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>efficiency in visual function with dorzolamide after photocoagulation</measure>
    <time_frame>two months</time_frame>
    <description>Effectiveness of dorzolamide (2%) in visual function (visual acuity, contrast sensitivity, retinal sensitivity) after 2 months of photocoagulation (treatment for focal Clinically Significant Macular Edema)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Diabetic Retinopathy</condition>
  <condition>Diabetic Macular Edema</condition>
  <arm_group>
    <arm_group_label>Dorzolamide hydrochloride (2%)</arm_group_label>
    <description>dorzolamide: diabetic patients with clinical significally macular edema with treatment photocoagulation dorzolamide (2%) application 1 drop every 8 hours for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Sodium hyaluronate4mg</arm_group_label>
    <description>placebo: diabetic patients with clinically significant macular edema(focal), with photocoagulation sodium hyaluronate (0.5%) application 1 drop every 8 hours for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dorzolamide hydrochloride (2%)</intervention_name>
    <description>Subsequently photocoagulation treatment was applied according to the guidelines of the ETDRS, reevaluate the patient at 4 weeks.&#xD;
Patient 1 drop of topical drug in the treaty provided every 8 hours for 4 weeks eye and again 4 weeks after cited for evaluation will be placed</description>
    <arm_group_label>Dorzolamide hydrochloride (2%)</arm_group_label>
    <other_name>Pio-bag (2%)</other_name>
    <other_name>Iop-Sox (2%)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Sodium hyaluronate 4mg</intervention_name>
    <description>Intervention: Subsequently photocoagulation treatment was applied according to the guidelines of the ETDRS, reevaluate the patient at 4 weeks.&#xD;
Patient 1 drop of topical drug in the treaty provided every 8 hours for 4 weeks eye and again 4 weeks after cited for evaluation will be placed.</description>
    <arm_group_label>Placebo Sodium hyaluronate4mg</arm_group_label>
    <other_name>Zonaker (0.5%)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        the accessible population are type 2 diabetic patients treated with focal photocoagulation&#xD;
        in Hospital Juarez Mexico&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Patients 40 to 70 years with diabetic retinopathy indistinct gender&#xD;
&#xD;
               -  Clinically significant macular edema&#xD;
&#xD;
               -  Focal Filtration in fluorescein angiography&#xD;
&#xD;
               -  Means optical transparent&#xD;
&#xD;
               -  Haemoglobin less than 7% (170)&#xD;
&#xD;
               -  Best-corrected visual acuity ≥ 20/200&#xD;
&#xD;
               -  Signed Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Presence of other retinal or optic nerve diseases&#xD;
&#xD;
               -  Presence of any other maculopathy&#xD;
&#xD;
               -  Patient diagnosed with allergy to sulfa&#xD;
&#xD;
               -  Patient with previous eye surgery four months&#xD;
&#xD;
               -  Patients with prior application of focal photocoagulation&#xD;
&#xD;
               -  Patients who use contact lenses 2 days before the application of photocoagulation&#xD;
&#xD;
               -  Presence of external eye disease, infection, inflammation at the time of&#xD;
                  evaluation&#xD;
&#xD;
               -  The presence of corneal disease present&#xD;
&#xD;
               -  Refractive errors higher than 6.00 D (sphere) -3.00 D (cylinder)&#xD;
&#xD;
               -  Study macular Fluorangiography Ischemia&#xD;
&#xD;
               -  Thickness of the central field&gt; 300 microns&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Virgilio Lima Gomez, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Juárez de México</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dulce Mi Razo-Blanco Hernandez, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Juarez de Mexico</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Surisadai Serafín Solis</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto Politecnico Nacional</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Virgilio Lima Gómez, MD, PhD</last_name>
    <phone>015255477560</phone>
    <phone_ext>7503</phone_ext>
    <email>vlimag@eninfinitum.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dulce Mi Razo-Blanco Hernandez, M, PhD</last_name>
    <phone>015255477560</phone>
    <phone_ext>7503</phone_ext>
    <email>razoblanco.dulce@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Juarez de Mexico</name>
      <address>
        <city>Mexico City</city>
        <zip>07760</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>VIRGILIO LIMA GOMEZ, MD, PhD</last_name>
      <phone>015255477560</phone>
      <phone_ext>7503</phone_ext>
      <email>vlimag@eninfinitum.com</email>
    </contact>
    <contact_backup>
      <last_name>DULCE MI RAZO-BLANCO HERNANDEZ, MD, PhD</last_name>
      <phone>015255477560</phone>
      <phone_ext>7503</phone_ext>
      <email>razoblanco.dulce@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Virgilio Lima Gomez, Md, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Surisadai Serafín Solís</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>March 18, 2015</last_update_submitted>
  <last_update_submitted_qc>March 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Juarez de Mexico</investigator_affiliation>
    <investigator_full_name>Virgilio Lima Gomez</investigator_full_name>
    <investigator_title>PhMD, retinology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dorzolamide</mesh_term>
    <mesh_term>Hyaluronic Acid</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/NCT02227745
org study id: HJM 2296/14-R
nct id: NCT02227745
lead sponsor: 
has dmc: No
Photocoagulation is the standard treatment in the focal EMCS, disrupts vascular leakage and
      allows the pigment epithelium remove the intraretinal fluid is effective in reducing the
      incidence of visual loss but can reduce contrast sensitivity and retinal sensitivity, the
      characteristics of the function can be reduced such as setting (location and stability) are
      relevant to the quality of the patient's vision parameters, reading comprehension, especially
      the ability, duration of diabetic macular edema, could have a significant impact on survival
      and / or the functional reserve of the macular cells subjected to mechanical and toxic
      stress-induced edema. It seems that in the treatment of patients with EMCS, photoreceptor
      damage occurs as a recent phenomenon, and can precede neurodegeneration retinal photoreceptor
      loss, whereby visual function can be decreased. An adjunctive treatment as Dorzolamide
      facilitating effect helping resorption of intraretinal fluid through EPR and reduce adverse
      events that is the loss of contrast sensitivity and retinal sensitivity, response time of
      photocoagulation treatment could be reduced to the patient, because the rate of resorption of
      intraretinal fluid is facilitated and thus the duration of the response, also could reduce
      damage to vision caused by the inadequacies of the photoreceptors during the evolution of
      macular edema avoiding moderate visual loss, there by increasing the quality of life in terms
      of improving the quality of vision in diabetic patients. In addition to obtaining a specific
      adjuvant treatment with photocoagulation is helpful for focal edema in diabetic and a new
      level using dorzolamide in retina Dorzolamide as adjunctive therapy after focal
      photocoagulation is more effective than placebo in improving visual function in patients with
      diabetic macular edema
Patients referred to ophthalmology for developing type 2 diabetes subspecialist
      ophthalmologist evaluate the macula them by biomicroscopy, pupillary dilation, to detect
      clinically significant macular edema. EMCS diagnosis is made according to ETDRS criteria, and
      patients who were requested to submit fluorescein angiography.

      Patients presenting with focal leakage on angiography were scheduled focal photocoagulation;
      day focal photocoagulation is measured before the procedure Measurement of visual acuity,
      visual acuity, refraction Measuring contrast sensitivity Measurement of retinal sensitivity
      Measurement of Optical Coherence Tomography ophthalmoscopic review

      Subsequently photocoagulation treatment was applied according to the guidelines of the ETDRS
      (1-50 number of shots, shot diameter of 100 microns and 120-180 mW power) and the patient was
      re-evaluated at 4 weeks, which will repeat the testing day photocoagulation.

      The patient what the research project will be discussed, will be invited to participate, will
      be read and informed consent was explained, questions and concerns will be clarified during
      the study, and patients who agree to enter the study will be assigned so random treatment.

      Patient 1 drop of topical drug in the treaty provided every 8 hours for 4 weeks eye is
      placed, the drug provided will be needed for 4 weeks, plus a control sheet dose delivery will
      be provided and shall be referenced again in April weeks later for evaluation:

      After 4 weeks of topical treatment, evaluation from 8:00 to 11 pm will be the same from the
      first date
observational model: Cohort
time perspective: Prospective
measure: efficiency in visual function with dorzolamide after photocoagulation
time frame: two months
description: Effectiveness of dorzolamide (2%) in visual function (visual acuity, contrast sensitivity, retinal sensitivity) after 2 months of photocoagulation (treatment for focal Clinically Significant Macular Edema)
arm group label: Dorzolamide hydrochloride (2%)
description: dorzolamide: diabetic patients with clinical significally macular edema with treatment photocoagulation dorzolamide (2%) application 1 drop every 8 hours for 4 weeks
arm group label: Placebo Sodium hyaluronate4mg
description: placebo: diabetic patients with clinically significant macular edema(focal), with photocoagulation sodium hyaluronate (0.5%) application 1 drop every 8 hours for 4 weeks
intervention type: Drug
intervention name: Dorzolamide hydrochloride (2%)
description: Subsequently photocoagulation treatment was applied according to the guidelines of the ETDRS, reevaluate the patient at 4 weeks.
Patient 1 drop of topical drug in the treaty provided every 8 hours for 4 weeks eye and again 4 weeks after cited for evaluation will be placed
arm group label: Dorzolamide hydrochloride (2%)
other name: Pio-bag (2%)
other name: Iop-Sox (2%)
intervention type: Drug
intervention name: Placebo Sodium hyaluronate 4mg
description: Intervention: Subsequently photocoagulation treatment was applied according to the guidelines of the ETDRS, reevaluate the patient at 4 weeks.
Patient 1 drop of topical drug in the treaty provided every 8 hours for 4 weeks eye and again 4 weeks after cited for evaluation will be placed.
arm group label: Placebo Sodium hyaluronate4mg
other name: Zonaker (0.5%)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Virgilio Lima Gomez, MD, PhD
role: Principal Investigator
affiliation: Hospital Juárez de México
last name: Dulce Mi Razo-Blanco Hernandez, MD, PhD
role: Study Chair
affiliation: Hospital Juarez de Mexico
last name: Surisadai Serafín Solis
role: Study Chair
affiliation: Instituto Politecnico Nacional
last name: Virgilio Lima Gómez, MD, PhD
phone: 015255477560
phone ext: 7503
email: vlimag@eninfinitum.com
last name: Dulce Mi Razo-Blanco Hernandez, M, PhD
phone: 015255477560
phone ext: 7503
email: razoblanco.dulce@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Hospital Juarez de Mexico
investigator full name: Virgilio Lima Gomez
investigator title: PhMD, retinology
mesh term: Macular Edema
mesh term: Diabetic Retinopathy
mesh term: Edema
mesh term: Dorzolamide
mesh term: Hyaluronic Acid