<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/NCT04426734</url>
  </required_header>
  <id_info>
    <org_study_id>OT V1</org_study_id>
    <nct_id>NCT04426734</nct_id>
  </id_info>
  <brief_title>Evaluation of DEXTENZA in the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids</brief_title>
  <acronym>DiverT</acronym>
  <official_title>Evaluation of DEXTENZA on the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New England Retina Associates</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ocular Therapeutix</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>New England Retina Associates</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This a prospective study review of the clinical efficacy of DEXTENZA for the treatment of&#xD;
      anterior uveitis compared to the standard of care topical corticosteroid treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with anterior uveitis are typically treated aggressively with every 1-2 hour (while&#xD;
      the patient is awake) potent topical steroid agents, during initial stage of inflammation,&#xD;
      and evaluated at frequent intervals, with a schedule of steroid tapering dictated by clinical&#xD;
      response. The most common topical corticosteroid prescribed for the treatment of anterior&#xD;
      uveitis are prednisolone acetate 1%, dexamethasone 0.1%, prednisolone sodium phosphate 1% and&#xD;
      Difluprednate 0.05%. However, topical treatments are limited by the potential for patient&#xD;
      non-adherence and variation in drug concentrations due to the intermittent or suspension of&#xD;
      use nature of application. A corticosteroid insert placed in the inferior and superior&#xD;
      canaliculi provides the advantages of reliable and continuous drug delivery for 24 hours a&#xD;
      day for 30 days without the need for patients to adhere to a treatment regimen. Dextenza is a&#xD;
      sustained-release dexamethasone intracanalicular insert recently approved by the FDA for pain&#xD;
      and inflammation post ophthalmic surgery. Dextenza was shown to decrease inflammation and&#xD;
      pain compared with placebo following cataract surgery in a multicenter randomized clinical&#xD;
      trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Sustained Release Dexamethasone, 0.4 mg, intracanalicular insert&#xD;
Thirty patients with anterior uveitis will be randomized to receive either:&#xD;
Sustained Released 0.4 mg Dexamethasone intracanalicular insert in both upper and lower punctum.&#xD;
OR&#xD;
Topical corticosteroid (Pred Forte, prednisolone acetate 1%) standard of care tapered treatment regimen of&#xD;
8x/day week 1 4x/day week 2 2x/day week 3&#xD;
1x/day week 4&#xD;
Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Response of Anterior Uveitis to Treatment</measure>
    <time_frame>30 days</time_frame>
    <description>Proportion of Subjects with Anterior Chamber Cell Grade of 0 from baseline at days 3, 7, 14, and 30</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improve 2 grade levels by SUN grading system</measure>
    <time_frame>30 days</time_frame>
    <description>• Proportion of subjects with a reduction in anterior chamber cell count score of 2 or more SUN grading scale levels from baseline at Days 3, 7, 14, and 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in cells</measure>
    <time_frame>30 days</time_frame>
    <description>Mean change from baseline in anterior chamber cell scores at days 3, 7, 14 and 30.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in flare</measure>
    <time_frame>30 days</time_frame>
    <description>Mean change from baseline in anterior chamber cell flare scores at days 3, 7, 14 and 30.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to zero inflammation</measure>
    <time_frame>30 days</time_frame>
    <description>Time to anterior cell count score of zero from baseline over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OCT</measure>
    <time_frame>30 days</time_frame>
    <description>Mean change from baseline in retinal thickness as measured by Optical Coherence Tomography (OCT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CME</measure>
    <time_frame>30 days</time_frame>
    <description>Proportion of patients who develop cystoid macular edema from baseline at days 3, 7, 14, and 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of resolution of CME</measure>
    <time_frame>30 days</time_frame>
    <description>Proportion of patients with resolution of retinal thickness (normalized retinal thickness) from baseline through day 30 as measured by OCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in Visual Acuity</measure>
    <time_frame>30 days</time_frame>
    <description>Mean change in BCVA from baseline at days 3, 7, 14 and 30.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IOP</measure>
    <time_frame>30 days</time_frame>
    <description>Mean change in IOP from baseline at days 3, 7, 14 and 30.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NEI-VQ-25</measure>
    <time_frame>30 days</time_frame>
    <description>Mean change in NEI-VFQ 25 from baseline to day 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue therapy</measure>
    <time_frame>30 days</time_frame>
    <description>Percentage of study eyes requiring rescue treatment from baseline through day 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>30 days</time_frame>
    <description>Incidence and severity of adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Non-infectious Anterior Uveitis</condition>
  <arm_group>
    <arm_group_label>Dextenza</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sustained Released 0.4 mg Dexamethasone intracanalicular insert in both upper and lower punctum.&#xD;
Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Topical Pred Forte 1%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topical corticosteroid (Pred Forte, prednisolone acetate 1%) standard of care tapered treatment regimen of&#xD;
8x/day week 1 4x/day week 2 2x/day week 3&#xD;
1x/day week 4&#xD;
Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dextenza Dexamethasone Implant</intervention_name>
    <description>The area of the punctum is first anesthetized with eye drops. A localized injection of lidocaine in perform once the surface of the punctum is numbed with the eyedrop. After 5-10 minutes, the corner of the eyelid and the region of the punctum will be fully anesthetic. The upper and lower punctum are then dilated with a punctum dilator to facilitate the insertion of the DEXTENZA medication. The DEXTENZA medication is then inserted using smooth forceps into the dilated opening of the upper and lower punctum. Once the DEXTENZA is inserted into the both the upper and lower punctum, the procedure is down. No repeated insertion of the DEXTENZA is required for the study.</description>
    <arm_group_label>Dextenza</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical Prednisolone Acetate 1%</intervention_name>
    <description>Topical corticosteroid (Pred Forte, prednisolone acetate 1%) standard of care tapered treatment regimen of&#xD;
8x/day week 1 4x/day week 2 2x/day week 3&#xD;
1x/day week 4&#xD;
Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30</description>
    <arm_group_label>Topical Pred Forte 1%</arm_group_label>
    <other_name>Topical Pred Forte 1%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 18 years old&#xD;
&#xD;
          -  Active non-infectious anterior uveitis&#xD;
&#xD;
          -  Able to provide signed written consent prior to participation in any study-related&#xD;
             procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have active intermediate, posterior uveitis, or panuveitis&#xD;
&#xD;
          -  Have infectious anterior uveitis&#xD;
&#xD;
          -  Have used topical corticosteroid treatment up to 48 hours prior to the baseline visit&#xD;
&#xD;
          -  Have used oral corticosteroid within the past 14 days prior to baseline visit&#xD;
             (Patients using stable doses of inhaled corticosteroids for 30 days prior to baseline&#xD;
             visit can be included in the study)&#xD;
&#xD;
          -  Have received intravitreal or sub-Tenon corticosteroid treatment prior to baseline&#xD;
             visit or Ozurdex ® in the study eye within the 6 months prior to the baseline visit&#xD;
&#xD;
          -  Are currently using prescribed nonsteroidal anti-inflammatory agents or prescribed&#xD;
             immunosuppressive agents, unless the dose has been stable for the last 6 weeks and no&#xD;
             change in dosing is anticipated for the duration of the study&#xD;
&#xD;
          -  Have severe/serious ocular pathology or medical condition which may preclude study&#xD;
             completion&#xD;
&#xD;
          -  Dacriocystitis&#xD;
&#xD;
          -  Are pregnant or lactating female, or female of childbearing age using inadequate birth&#xD;
             control method&#xD;
&#xD;
          -  Have participated in another investigational device or drug study within 30 days of&#xD;
             the baseline visit&#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_contact>
    <last_name>John Huang</last_name>
    <phone>2032882020</phone>
    <email>jjqhuang@yahoo.com</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>New England Retina Associates</investigator_affiliation>
    <investigator_full_name>John Huang, MD</investigator_full_name>
    <investigator_title>Ophthalmologist and Clinical Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uveitis</mesh_term>
    <mesh_term>Uveitis, Anterior</mesh_term>
    <mesh_term>Iridocyclitis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This data will be analyzed and published by the principle investigator.</ipd_description>
  </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/NCT04426734
org study id: OT V1
nct id: NCT04426734
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
This a prospective study review of the clinical efficacy of DEXTENZA for the treatment of
      anterior uveitis compared to the standard of care topical corticosteroid treatment
Patients with anterior uveitis are typically treated aggressively with every 1-2 hour (while
      the patient is awake) potent topical steroid agents, during initial stage of inflammation,
      and evaluated at frequent intervals, with a schedule of steroid tapering dictated by clinical
      response. The most common topical corticosteroid prescribed for the treatment of anterior
      uveitis are prednisolone acetate 1%, dexamethasone 0.1%, prednisolone sodium phosphate 1% and
      Difluprednate 0.05%. However, topical treatments are limited by the potential for patient
      non-adherence and variation in drug concentrations due to the intermittent or suspension of
      use nature of application. A corticosteroid insert placed in the inferior and superior
      canaliculi provides the advantages of reliable and continuous drug delivery for 24 hours a
      day for 30 days without the need for patients to adhere to a treatment regimen. Dextenza is a
      sustained-release dexamethasone intracanalicular insert recently approved by the FDA for pain
      and inflammation post ophthalmic surgery. Dextenza was shown to decrease inflammation and
      pain compared with placebo following cataract surgery in a multicenter randomized clinical
      trial.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: Sustained Release Dexamethasone, 0.4 mg, intracanalicular insert
Thirty patients with anterior uveitis will be randomized to receive either:
Sustained Released 0.4 mg Dexamethasone intracanalicular insert in both upper and lower punctum.
OR
Topical corticosteroid (Pred Forte, prednisolone acetate 1%) standard of care tapered treatment regimen of
8x/day week 1 4x/day week 2 2x/day week 3
1x/day week 4
Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30
primary purpose: Treatment
masking: None (Open Label)
measure: Response of Anterior Uveitis to Treatment
time frame: 30 days
description: Proportion of Subjects with Anterior Chamber Cell Grade of 0 from baseline at days 3, 7, 14, and 30
measure: Improve 2 grade levels by SUN grading system
time frame: 30 days
description: • Proportion of subjects with a reduction in anterior chamber cell count score of 2 or more SUN grading scale levels from baseline at Days 3, 7, 14, and 30
measure: Mean change in cells
time frame: 30 days
description: Mean change from baseline in anterior chamber cell scores at days 3, 7, 14 and 30.
measure: Mean change in flare
time frame: 30 days
description: Mean change from baseline in anterior chamber cell flare scores at days 3, 7, 14 and 30.
measure: Time to zero inflammation
time frame: 30 days
description: Time to anterior cell count score of zero from baseline over time
measure: OCT
time frame: 30 days
description: Mean change from baseline in retinal thickness as measured by Optical Coherence Tomography (OCT)
measure: CME
time frame: 30 days
description: Proportion of patients who develop cystoid macular edema from baseline at days 3, 7, 14, and 30
measure: Proportion of resolution of CME
time frame: 30 days
description: Proportion of patients with resolution of retinal thickness (normalized retinal thickness) from baseline through day 30 as measured by OCT
measure: Mean change in Visual Acuity
time frame: 30 days
description: Mean change in BCVA from baseline at days 3, 7, 14 and 30.
measure: IOP
time frame: 30 days
description: Mean change in IOP from baseline at days 3, 7, 14 and 30.
measure: NEI-VQ-25
time frame: 30 days
description: Mean change in NEI-VFQ 25 from baseline to day 30
measure: Rescue therapy
time frame: 30 days
description: Percentage of study eyes requiring rescue treatment from baseline through day 30
measure: Adverse events
time frame: 30 days
description: Incidence and severity of adverse events
arm group label: Dextenza
arm group type: Experimental
description: Sustained Released 0.4 mg Dexamethasone intracanalicular insert in both upper and lower punctum.
Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30
arm group label: Topical Pred Forte 1%
arm group type: Active Comparator
description: Topical corticosteroid (Pred Forte, prednisolone acetate 1%) standard of care tapered treatment regimen of
8x/day week 1 4x/day week 2 2x/day week 3
1x/day week 4
Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30
intervention type: Device
intervention name: Dextenza Dexamethasone Implant
description: The area of the punctum is first anesthetized with eye drops. A localized injection of lidocaine in perform once the surface of the punctum is numbed with the eyedrop. After 5-10 minutes, the corner of the eyelid and the region of the punctum will be fully anesthetic. The upper and lower punctum are then dilated with a punctum dilator to facilitate the insertion of the DEXTENZA medication. The DEXTENZA medication is then inserted using smooth forceps into the dilated opening of the upper and lower punctum. Once the DEXTENZA is inserted into the both the upper and lower punctum, the procedure is down. No repeated insertion of the DEXTENZA is required for the study.
arm group label: Dextenza
intervention type: Drug
intervention name: Topical Prednisolone Acetate 1%
description: Topical corticosteroid (Pred Forte, prednisolone acetate 1%) standard of care tapered treatment regimen of
8x/day week 1 4x/day week 2 2x/day week 3
1x/day week 4
Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30
arm group label: Topical Pred Forte 1%
other name: Topical Pred Forte 1%
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Huang
phone: 2032882020
email: jjqhuang@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: New England Retina Associates
investigator full name: John Huang, MD
investigator title: Ophthalmologist and Clinical Associate Professor
mesh term: Uveitis
mesh term: Uveitis, Anterior
mesh term: Iridocyclitis
mesh term: Inflammation
mesh term: Dexamethasone
mesh term: Prednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone acetate
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
sharing ipd: No
ipd description: This data will be analyzed and published by the principle investigator.