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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-infectious Anterior Uveitis

Intervention / Treatment
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* Device: Dextenza Dexamethasone Implant
* Drug: Topical Prednisolone Acetate 1%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextenza<br>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<br>* 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.<br>|
| Active Comparator: Topical Pred Forte 1%<br>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%<br>* 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<br>* Other names: Topical Pred Forte 1%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days | 

Secondary Outcome Measures

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