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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)

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ClinicalTrials.gov Identifier: NCT04426734
Recruitment Status : Not yet recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Ocular Therapeutix
Information provided by (Responsible Party):
John Huang, MD, New England Retina Associates

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

Condition or disease Intervention/treatment Phase
Non-infectious Anterior Uveitis Device: Dextenza Dexamethasone Implant Drug: Topical Prednisolone Acetate 1% Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of DEXTENZA on the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021


Arm Intervention/treatment
Experimental: Dextenza

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

Device: Dextenza Dexamethasone Implant
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.

Active Comparator: Topical Pred Forte 1%

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

Drug: Topical Prednisolone Acetate 1%

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

Other Name: Topical Pred Forte 1%




Primary Outcome Measures :
  1. Response of Anterior Uveitis to Treatment [ Time Frame: 30 days ]
    Proportion of Subjects with Anterior Chamber Cell Grade of 0 from baseline at days 3, 7, 14, and 30


Secondary Outcome Measures :
  1. Improve 2 grade levels by SUN grading system [ Time Frame: 30 days ]
    • 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

  2. Mean change in cells [ Time Frame: 30 days ]
    Mean change from baseline in anterior chamber cell scores at days 3, 7, 14 and 30.

  3. Mean change in flare [ Time Frame: 30 days ]
    Mean change from baseline in anterior chamber cell flare scores at days 3, 7, 14 and 30.

  4. Time to zero inflammation [ Time Frame: 30 days ]
    Time to anterior cell count score of zero from baseline over time

  5. OCT [ Time Frame: 30 days ]
    Mean change from baseline in retinal thickness as measured by Optical Coherence Tomography (OCT)

  6. CME [ Time Frame: 30 days ]
    Proportion of patients who develop cystoid macular edema from baseline at days 3, 7, 14, and 30

  7. Proportion of resolution of CME [ Time Frame: 30 days ]
    Proportion of patients with resolution of retinal thickness (normalized retinal thickness) from baseline through day 30 as measured by OCT

  8. Mean change in Visual Acuity [ Time Frame: 30 days ]
    Mean change in BCVA from baseline at days 3, 7, 14 and 30.

  9. IOP [ Time Frame: 30 days ]
    Mean change in IOP from baseline at days 3, 7, 14 and 30.

  10. NEI-VQ-25 [ Time Frame: 30 days ]
    Mean change in NEI-VFQ 25 from baseline to day 30

  11. Rescue therapy [ Time Frame: 30 days ]
    Percentage of study eyes requiring rescue treatment from baseline through day 30

  12. Adverse events [ Time Frame: 30 days ]
    Incidence and severity of adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04426734


Contacts
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Contact: John Huang 2032882020 jjqhuang@yahoo.com

Sponsors and Collaborators
New England Retina Associates
Ocular Therapeutix
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Responsible Party: John Huang, MD, Ophthalmologist and Clinical Associate Professor, New England Retina Associates
ClinicalTrials.gov Identifier: NCT04426734    
Other Study ID Numbers: OT V1
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This data will be analyzed and published by the principle investigator.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Uveitis
Uveitis, Anterior
Iridocyclitis
Inflammation
Pathologic Processes
Uveal Diseases
Eye Diseases
Panuveitis
Iris Diseases
Dexamethasone
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neuroprotective Agents
Protective Agents