Clinical trial NCT04426734: Evaluation of DEXTENZA in the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-infectious Anterior Uveitis
Lead sponsor: New England Retina Associates
Sponsor class: OTHER
Collaborators: name: Ocular Therapeutix
First posted: 2020-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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

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.

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

Primary outcomes:
measure: Response of Anterior Uveitis to Treatment
timeFrame: 30 days
Secondary outcomes:
measure: Improve 2 grade levels by SUN grading system
timeFrame: 30 days
measure: Mean change in cells
timeFrame: 30 days
measure: Mean change in flare
timeFrame: 30 days
measure: Time to zero inflammation
timeFrame: 30 days
measure: OCT
timeFrame: 30 days
measure: CME
timeFrame: 30 days
measure: Proportion of resolution of CME
timeFrame: 30 days
measure: Mean change in Visual Acuity
timeFrame: 30 days
measure: IOP
timeFrame: 30 days
measure: NEI-VQ-25
timeFrame: 30 days
measure: Rescue therapy
timeFrame: 30 days
measure: Adverse events
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References: