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Corticosteroid

DEXTENZA for Glaucoma (DEXTenSiVe Trial)

Phase 4
Waitlist Available
Research Sponsored by Brian Jerkins, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through month 6
Awards & highlights

DEXTenSiVe Trial Summary

This trial is testing whether a higher dose of DEXTENZA is more effective than the standard care dexamethasone in patients undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, and Ahmed Valve surgery.

Eligible Conditions
  • Glaucoma Post-Surgery

DEXTenSiVe Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in intraocular pressure (IOP)
Secondary outcome measures
Conjunctival healing outcomes as defined by proportion of eyes requiring needling intervention associated with scar/fibrin development
Incidence and severity of adverse events
Mean change in Visual Field (MD)
+5 more

DEXTenSiVe Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DEXTENZAExperimental Treatment1 Intervention
a single intracanalicular dexamethasone (0.4 mg) insert
Group II: Topical Dexamethasone TreatmentActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Brian Jerkins, MDLead Sponsor
Ocular Therapeutix, Inc.Industry Sponsor
53 Previous Clinical Trials
5,547 Total Patients Enrolled
7 Trials studying Glaucoma
827 Patients Enrolled for Glaucoma

Media Library

DEXTENZA (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05116345 — Phase 4
Glaucoma Research Study Groups: Topical Dexamethasone Treatment, DEXTENZA
Glaucoma Clinical Trial 2023: DEXTENZA Highlights & Side Effects. Trial Name: NCT05116345 — Phase 4
DEXTENZA (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05116345 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can DEXTENZA be considered harmful to individuals?

"A score of 3, the highest rating available, was given to DEXTENZA due to its status as a Phase 4 trial; this signifies that it has already been approved for use."

Answered by AI

What prior experiments have been conducted relating to DEXTENZA?

"Currently, DEXTENZA is being evaluated in 553 active clinical trials with 144 of them reaching Phase 3. While the great majority are taking place around Mishawaka, Indiana, it has been studied at 18618 distinct locations worldwide."

Answered by AI

What medical conditions typically require DEXTENZA treatment?

"DEXTENZA is primarily used to treat ophthalmia, sympathetic, however it has been known to be effective for other eye-related conditions like branch retinal vein occlusion and macular edema."

Answered by AI

Is this research project still enrolling participants?

"At this juncture, the trial is not accepting any new patients. The research was initially posted on November 1st 2021 and edited for the last time of November 9th 2021. For those interested in other clinical trials, 355 studies related to inflammation are currently recruiting while 553 are searching for DEXTENZA participants."

Answered by AI

What is the current enrolment figure for this research project?

"This experiment is no longer taking on new participants. The clinical trial was opened to enrollment in November 2021 and the listing was last updated that same month. If you are interested in other research, there are presently 355 studies recruiting patients with inflammation issues as well as 553 trials seeking volunteers for DEXTENZA testing."

Answered by AI
~9 spots leftby Apr 2025