<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/NCT04460001</url>
  </required_header>
  <id_info>
    <org_study_id>WAMohamed</org_study_id>
    <nct_id>NCT04460001</nct_id>
  </id_info>
  <brief_title>Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for (CRVO)</brief_title>
  <official_title>Intravitreal Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for the Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the clinical effectiveness of ranibizumab and combination of ranibizumab and&#xD;
      triamcinolone for the treatment of macular oedema secondary to CRVO&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 16, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO</measure>
    <time_frame>2 year</time_frame>
    <description>To compare the clinical effectiveness of 0.5 mg ranibizumab and combination of ranibizumab and triamcinolone 0.3/0.5mg for the treatment of macular oedema secondary to CRVO.Study assessments will be performed at screening, baseline and at monthly visits:&#xD;
Best-Corrected Visual Acuity:&#xD;
will be assessed at every study visit by using alandolt ringes VA testing chart at an initial testing distance of 6 m.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO</measure>
    <time_frame>2 year</time_frame>
    <description>To compare the clinical effectiveness of 0.5 mg ranibizumab and combination of ranibizumab and triamcinolone 0.3/0.5mg for the treatment of macular oedema secondary to CRVO.Study assessments will be performed at screening, baseline and at monthly visits:&#xD;
Optical Coherence Tomography:&#xD;
will be performed at every visit and the same machine will be used for assessment of the same patient throughout the study. investigator will evaluate the images according to central foveal thickness, and the retinal thickness at the foveal center point and to capture the presence or absence of qualitative parameters (i.e., intraretinal cystoid fluid and subretinal fluid).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Ophthalmopathy</condition>
  <arm_group>
    <arm_group_label>Ranibizumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intravetreal injection of Ranibizumab alone for treatment of patients with macular oedema after CRVO once per month and follow up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ranibizumab and triamcinolone acetate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intravetreal injection of Ranibizumab and triamcinolone acetate for treatment of patients with macular oedema after CRVO once per month and follow up</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranibizumab</intervention_name>
    <description>Intravitreal</description>
    <arm_group_label>Ranibizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranibizumab</intervention_name>
    <description>Intravitreal</description>
    <arm_group_label>Ranibizumab and triamcinolone acetate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>triamcinolone acetate</intervention_name>
    <description>intravitreal</description>
    <arm_group_label>Ranibizumab and triamcinolone acetate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 years of age or older with visual impairment resulting from macular edema&#xD;
             secondary to CRVO.&#xD;
&#xD;
          -  A BCVA approximate Snellen equivalents, 20/40.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of intra-vitreal anti-VEGF injections 3 months or less before baseline.&#xD;
&#xD;
          -  Pan-retinal laser photocoagulation 3 months or less before baseline,&#xD;
&#xD;
          -  Topical ocular or systemic corticosteroids administered for 30 consecutive days.&#xD;
&#xD;
          -  Intraocular or periocular corticosteroid use 3 months or less before screening (study&#xD;
             eye),&#xD;
&#xD;
          -  Use of intraocular corticosteroid implants,&#xD;
&#xD;
          -  Uncontrolled glaucoma (intraocular pressure [IOP] 30 mmHg with medication) at the time&#xD;
             of screening or baseline,&#xD;
&#xD;
          -  iris neovascularization or neo-vascular glaucoma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Wael Ismael</last_name>
    <phone>01006322380</phone>
    <email>wael.ali.ismael@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wael</name>
      <address>
        <city>Asyut</city>
        <zip>11711</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wael Ismael</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 1, 2019</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Wael Ali Mohamed</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eye Diseases</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>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04460001
org study id: WAMohamed
nct id: NCT04460001
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To compare the clinical effectiveness of ranibizumab and combination of ranibizumab and
      triamcinolone for the treatment of macular oedema secondary to CRVO
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO
time frame: 2 year
description: To compare the clinical effectiveness of 0.5 mg ranibizumab and combination of ranibizumab and triamcinolone 0.3/0.5mg for the treatment of macular oedema secondary to CRVO.Study assessments will be performed at screening, baseline and at monthly visits:
Best-Corrected Visual Acuity:
will be assessed at every study visit by using alandolt ringes VA testing chart at an initial testing distance of 6 m.
measure: Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO
time frame: 2 year
description: To compare the clinical effectiveness of 0.5 mg ranibizumab and combination of ranibizumab and triamcinolone 0.3/0.5mg for the treatment of macular oedema secondary to CRVO.Study assessments will be performed at screening, baseline and at monthly visits:
Optical Coherence Tomography:
will be performed at every visit and the same machine will be used for assessment of the same patient throughout the study. investigator will evaluate the images according to central foveal thickness, and the retinal thickness at the foveal center point and to capture the presence or absence of qualitative parameters (i.e., intraretinal cystoid fluid and subretinal fluid).
arm group label: Ranibizumab
arm group type: Active Comparator
description: intravetreal injection of Ranibizumab alone for treatment of patients with macular oedema after CRVO once per month and follow up
arm group label: Ranibizumab and triamcinolone acetate
arm group type: Active Comparator
description: intravetreal injection of Ranibizumab and triamcinolone acetate for treatment of patients with macular oedema after CRVO once per month and follow up
intervention type: Drug
intervention name: Ranibizumab
description: Intravitreal
arm group label: Ranibizumab
intervention type: Drug
intervention name: Ranibizumab
description: Intravitreal
arm group label: Ranibizumab and triamcinolone acetate
intervention type: Drug
intervention name: triamcinolone acetate
description: intravitreal
arm group label: Ranibizumab and triamcinolone acetate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wael Ismael
phone: 01006322380
email: wael.ali.ismael@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Wael Ali Mohamed
investigator title: Principal Investigator
mesh term: Eye Diseases
mesh term: Triamcinolone
mesh term: Ranibizumab
sharing ipd: Undecided