DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures (DEXTenSiVe)

Brian Jerkins, MD

Status and phase: Unknown; Phase 4

Conditions: Glaucoma Following Surgery

Treatments: Drug: DEXTENZA; Drug: Topical Dexamethasone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05116345

The DEXTenSiVe Study

Details and patient eligibility

About

This is a prospective, comparative, open-label, single-center, randomized, investigator-sponsored clinical study and seeks to investigate clinical outcomes with standard of care and high dose DEXTENZA treatment compared to standard of care topical dexamethasone in patients undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, and Ahmed Valve surgery. Patients will be followed through 6 months. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, eyes of n=30 patients will be randomized to one of the following two groups (n=15per group) and followed from Baseline through Month 6.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Able to provide signed written consent prior to participation in any study-related procedures
• Patient is diagnosed with glaucoma and undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, or Ahmed Valve surgery

Exclusion criteria

• 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
• 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
• Anterior chamber cells present at time of enrollment
• Known allergy to dexamethasone or prednisolone

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

DEXTENZA

Experimental group

Description:

a single intracanalicular dexamethasone (0.4 mg) insert

Treatment:

Drug: DEXTENZA

Topical Dexamethasone Treatment

Active Comparator group

Description:

Standard of care topical dexamethasone treatment through Month 2 dosing and tapering following: 6x/day week 1 4x/day weeks 2-4 2x/day weeks 5-8 Day of surgery dexamethasone ointment and patch will be applied post-surgically for overnight treatment and removed at post-operative day 1 visit in Group B eyes.

Treatment:

Drug: Topical Dexamethasone