NCT04426734

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: New England Retina Associates · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-infectious Anterior Uveitis

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2020-07-01
• Primary completion: 2020-12-31
• Completion: 2021-03-31
• First posted: 2020-06-11
• Last updated: 2020-06-11

Regulatory

• FDA-regulated drug study
• FDA-regulated device study