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

NCT05116345 | Unknown Phase 4 FDA Drug

• 1 other identifier: The DEXTenSiVe Study
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma Following Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Mean change in best corrected visual acuity (BCVA)

  From baseline through month 6

• Mean change in Visual Field (MD)

  From baseline through month 6

• 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

  From baseline through month 6

• Time to resolution of anterior chamber (AC) cells and/or AC flare

  From baseline through month 6

Study Arms (2)

DEXTENZA

EXPERIMENTAL

a single intracanalicular dexamethasone (0.4 mg) insert

Drug: DEXTENZA

Topical Dexamethasone Treatment

ACTIVE COMPARATOR

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

Interventions

DEXTENZA DRUG

Intracanalicular Dexamethasone ophthalmic insert (0.4mg)

Also known as: Dexamethasone (0.4mg) Insert

DEXTENZA

Topical Dexamethasone DRUG

topical dexamethasone drops

Topical Dexamethasone Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brian Jerkins, MD: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

Hamilton Eye Institute

Memphis, Tennessee, 38103, United States

Location

Related Publications (2)

• 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.

  PMID: 19084273 BACKGROUND

• 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.

  PMID: 32700064 BACKGROUND

MeSH Terms

Interventions

Calcium Dobesilate; Dexamethasone; Mutagenesis, Insertional

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Study Officials

• Brian Jerkins, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Jerkins, MD

CONTACT

901-338-1022; bjerkins@uthsc.edu

Breia N. Dooley, MA

CONTACT

901-448-3269; bdooley3@uthsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 11, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 11, 2021

Record last verified: 2021-11

Locations

US (1)