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

NCT04426734 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: OT V1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Non-infectious Anterior Uveitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Improve 2 grade levels by SUN grading system

  30 days

• Mean change in cells

  30 days

• Mean change in flare

  30 days

• Time to zero inflammation

  30 days

• OCT

  30 days

Study Arms (2)

Dextenza

EXPERIMENTAL

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

Topical Pred Forte 1%

ACTIVE COMPARATOR

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%

Interventions

Dextenza Dexamethasone Implant DEVICE

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.

Dextenza

Topical Prednisolone Acetate 1% DRUG

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

Also known as: Topical Pred Forte 1%

Topical Pred Forte 1%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years old
• Active non-infectious anterior uveitis
• Able to provide signed written consent prior to participation in any study-related procedures.

You may not qualify if:

• 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

Sponsors & Collaborators

• New England Retina Associates: lead
• Ocular Therapeutix: collaborator

Central Study Contacts

John Huang

CONTACT

2032882020; jjqhuang@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist and Clinical Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share