Your session is about to expire
← Back to Search
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline through month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through month 6
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 moreDEXTenSiVe 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an allergy to dexamethasone or prednisolone.You have taken part in another study with a new drug or device within the past month.You have been diagnosed with glaucoma and are currently undergoing certain types of glaucoma surgery such as trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, or Ahmed Valve surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Topical Dexamethasone Treatment
- Group 2: DEXTENZA
Awards:
This trial has 5 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger