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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Glaucoma Following Surgery
• Intervention / Treatment: Drug: DEXTENZA; Drug: Topical Dexamethasone

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Brian Jerkins, MD; Phone Number: 901-338-1022; Email: bjerkins@uthsc.edu
• Study Contact Backup: Name: Breia N. Dooley, MA; Phone Number: 901-448-3269; Email: bdooley3@uthsc.edu

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Hamilton Eye Institute
      • Contact: Brian Jerkins, MD; Phone Number: 901-338-1022; Email: bjerkins@uthsc.edu
      • Contact: Breia N. Dooley, MA; Phone Number: 901-448-3269; Email: bdooley3@uthsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DEXTENZA; a single intracanalicular dexamethasone (0.4 mg) insert	Drug: DEXTENZA; Intracanalicular Dexamethasone ophthalmic insert (0.4mg); Other Names: Dexamethasone (0.4mg) Insert
Active Comparator: Topical Dexamethasone Treatment; 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.	Drug: Topical Dexamethasone; topical dexamethasone drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in intraocular pressure (IOP)	mean change in intraocular pressure (IOP) from day of surgery and proportion of eyes requiring additional topical dexamethasone or anti-metabolite therapy over time	From baseline through month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in best corrected visual acuity (BCVA)	Mean change in BCVA using Snellen eye charts	From baseline through month 6
Mean change in Visual Field (MD)	Mean change in Visual Field (MD) will be detected using a perimeter device. The patient looks into the perimeter at a center target. Only one eye is tested at a time. The eye not being tested is covered with an eye patch. Small, dim lights will flash in the device and the patient will press a button each time they see the light. The results will show if the patient has had any changes in their visual field.	From baseline through month 6
Conjunctival healing outcomes as defined by proportion of eyes requiring needling intervention associated with scar/fibrin development	Conjunctival healing outcomes as defined by proportion of eyes requiring needling intervention associated with scar/fibrin development	From baseline through month 6
Proportion of eyes with absence of anterior chamber (AC) cells (score of 0) as measured by the Standardization of Uveitis Nomenclature (SUN) scale	Proportion of eyes with absence of anterior chamber (AC) cells (score of 0) as measured by the Standardization of Uveitis Nomenclature (SUN) scale	From baseline through month 6
Time to resolution of anterior chamber (AC) cells and/or AC flare	Time to resolution of anterior chamber (AC) cells and/or AC flare	From baseline through month 6
Proportion of eyes with absence of pain as measured by pain scale of 1-10 (pain score of 0 = absence)	Proportion of eyes with absence of pain as measured by pain scale of 1-10 (pain score of 0 = absence)	From baseline through month 6
Number of patient call backs to medical staff regarding post-operative management of pain or medication management/dosing inquiry as documented by Electronic Health Record (E.H.R.).	Number of patient call backs to medical staff regarding post-operative management of pain or medication management/dosing inquiry as documented by Electronic Health Record (E.H.R.).	From baseline through month 6
Incidence and severity of adverse events	Incidence and severity of adverse events	From baseline through month 6

Collaborators and Investigators

• Sponsor: Brian Jerkins, MD
• Collaborators: Ocular Therapeutix, Inc.
• Investigators: Principal Investigator: Brian Jerkins, MD, University of Tennessee

Publications and helpful links

General Publications

• Okeke CO, Quigley HA, Jampel HD, Ying GS, Plyler RJ, Jiang Y, Friedman DS. Adherence with topical glaucoma medication monitored electronically the Travatan Dosing Aid study. Ophthalmology. 2009 Feb;116(2):191-9. doi: 10.1016/j.ophtha.2008.09.004. Epub 2008 Dec 12.
• Lee A, Blair HA. Correction to: Dexamethasone Intracanalicular Insert: A Review in Treating Post-Surgical Ocular Pain and Inflammation. Drugs. 2020 Aug;80(12):1265. doi: 10.1007/s40265-020-01366-0.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: The DEXTenSiVe Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No