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Evaluation of DEXTENZA in the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids (DiverT)

Primary Purpose

Non-infectious Anterior Uveitis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dextenza Dexamethasone Implant
Topical Prednisolone Acetate 1%
Sponsored by
New England Retina Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-infectious Anterior Uveitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • > 18 years old
  • Active non-infectious anterior uveitis
  • Able to provide signed written consent prior to participation in any study-related procedures.

Exclusion Criteria:

  • Have active intermediate, posterior uveitis, or panuveitis
  • Have infectious anterior uveitis
  • Have used topical corticosteroid treatment up to 48 hours prior to the baseline visit
  • Have used oral corticosteroid within the past 14 days prior to baseline visit (Patients using stable doses of inhaled corticosteroids for 30 days prior to baseline visit can be included in the study)
  • Have received intravitreal or sub-Tenon corticosteroid treatment prior to baseline visit or Ozurdex ® in the study eye within the 6 months prior to the baseline visit
  • Are currently using prescribed nonsteroidal anti-inflammatory agents or prescribed immunosuppressive agents, unless the dose has been stable for the last 6 weeks and no change in dosing is anticipated for the duration of the study
  • Have severe/serious ocular pathology or medical condition which may preclude study completion
  • Dacriocystitis
  • Are pregnant or lactating female, or female of childbearing age using inadequate birth control method
  • Have participated in another investigational device or drug study within 30 days of the baseline visit

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Dextenza

    Topical Pred Forte 1%

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    Response of Anterior Uveitis to Treatment
    Proportion of Subjects with Anterior Chamber Cell Grade of 0 from baseline at days 3, 7, 14, and 30

    Secondary Outcome Measures

    Improve 2 grade levels by SUN grading system
    • 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
    Mean change in cells
    Mean change from baseline in anterior chamber cell scores at days 3, 7, 14 and 30.
    Mean change in flare
    Mean change from baseline in anterior chamber cell flare scores at days 3, 7, 14 and 30.
    Time to zero inflammation
    Time to anterior cell count score of zero from baseline over time
    OCT
    Mean change from baseline in retinal thickness as measured by Optical Coherence Tomography (OCT)
    CME
    Proportion of patients who develop cystoid macular edema from baseline at days 3, 7, 14, and 30
    Proportion of resolution of CME
    Proportion of patients with resolution of retinal thickness (normalized retinal thickness) from baseline through day 30 as measured by OCT
    Mean change in Visual Acuity
    Mean change in BCVA from baseline at days 3, 7, 14 and 30.
    IOP
    Mean change in IOP from baseline at days 3, 7, 14 and 30.
    NEI-VQ-25
    Mean change in NEI-VFQ 25 from baseline to day 30
    Rescue therapy
    Percentage of study eyes requiring rescue treatment from baseline through day 30
    Adverse events
    Incidence and severity of adverse events

    Full Information

    First Posted
    June 8, 2020
    Last Updated
    June 10, 2020
    Sponsor
    New England Retina Associates
    Collaborators
    Ocular Therapeutix
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04426734
    Brief Title
    Evaluation of DEXTENZA in the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids
    Acronym
    DiverT
    Official Title
    Evaluation of DEXTENZA on the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    March 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    New England Retina Associates
    Collaborators
    Ocular Therapeutix

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-infectious Anterior Uveitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    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
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dextenza
    Arm Type
    Experimental
    Arm 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 Title
    Topical Pred Forte 1%
    Arm Type
    Active Comparator
    Arm 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(s)
    Dextenza Dexamethasone Implant
    Intervention 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Topical Prednisolone Acetate 1%
    Other Intervention Name(s)
    Topical Pred Forte 1%
    Intervention 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
    Primary Outcome Measure Information:
    Title
    Response of Anterior Uveitis to Treatment
    Description
    Proportion of Subjects with Anterior Chamber Cell Grade of 0 from baseline at days 3, 7, 14, and 30
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Improve 2 grade levels by SUN grading system
    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
    Time Frame
    30 days
    Title
    Mean change in cells
    Description
    Mean change from baseline in anterior chamber cell scores at days 3, 7, 14 and 30.
    Time Frame
    30 days
    Title
    Mean change in flare
    Description
    Mean change from baseline in anterior chamber cell flare scores at days 3, 7, 14 and 30.
    Time Frame
    30 days
    Title
    Time to zero inflammation
    Description
    Time to anterior cell count score of zero from baseline over time
    Time Frame
    30 days
    Title
    OCT
    Description
    Mean change from baseline in retinal thickness as measured by Optical Coherence Tomography (OCT)
    Time Frame
    30 days
    Title
    CME
    Description
    Proportion of patients who develop cystoid macular edema from baseline at days 3, 7, 14, and 30
    Time Frame
    30 days
    Title
    Proportion of resolution of CME
    Description
    Proportion of patients with resolution of retinal thickness (normalized retinal thickness) from baseline through day 30 as measured by OCT
    Time Frame
    30 days
    Title
    Mean change in Visual Acuity
    Description
    Mean change in BCVA from baseline at days 3, 7, 14 and 30.
    Time Frame
    30 days
    Title
    IOP
    Description
    Mean change in IOP from baseline at days 3, 7, 14 and 30.
    Time Frame
    30 days
    Title
    NEI-VQ-25
    Description
    Mean change in NEI-VFQ 25 from baseline to day 30
    Time Frame
    30 days
    Title
    Rescue therapy
    Description
    Percentage of study eyes requiring rescue treatment from baseline through day 30
    Time Frame
    30 days
    Title
    Adverse events
    Description
    Incidence and severity of adverse events
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: > 18 years old Active non-infectious anterior uveitis Able to provide signed written consent prior to participation in any study-related procedures. Exclusion Criteria: Have active intermediate, posterior uveitis, or panuveitis Have infectious anterior uveitis Have used topical corticosteroid treatment up to 48 hours prior to the baseline visit Have used oral corticosteroid within the past 14 days prior to baseline visit (Patients using stable doses of inhaled corticosteroids for 30 days prior to baseline visit can be included in the study) Have received intravitreal or sub-Tenon corticosteroid treatment prior to baseline visit or Ozurdex ® in the study eye within the 6 months prior to the baseline visit Are currently using prescribed nonsteroidal anti-inflammatory agents or prescribed immunosuppressive agents, unless the dose has been stable for the last 6 weeks and no change in dosing is anticipated for the duration of the study Have severe/serious ocular pathology or medical condition which may preclude study completion Dacriocystitis Are pregnant or lactating female, or female of childbearing age using inadequate birth control method Have participated in another investigational device or drug study within 30 days of the baseline visit
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    John Huang
    Phone
    2032882020
    Email
    jjqhuang@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    This data will be analyzed and published by the principle investigator.

    Learn more about this trial

    Evaluation of DEXTENZA in the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids

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