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

Phase 4

• Conditions: Non-infectious Anterior Uveitis
• Interventions: Device: Dextenza Dexamethasone Implant; Drug: Topical Prednisolone Acetate 1%

• Registration Number: NCT04426734
• Lead Sponsor: 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

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.

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-10
• Last Update Submitted: 2020-06-10
• Study First Posted: 2020-06-11
• Last Update Posted: 2020-06-11
• Study Start: 2020-07-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dextenza	Dextenza Dexamethasone Implant	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 Pred Forte 1%	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

Primary Outcome Measures

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

Secondary Outcome Measures

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