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

Primary Purpose

Glaucoma Following Surgery

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
DEXTENZA
Topical Dexamethasone
Sponsored by
Brian Jerkins, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma Following Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Hamilton Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DEXTENZA

Topical Dexamethasone Treatment

Arm Description

a single intracanalicular dexamethasone (0.4 mg) insert

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean change in best corrected visual acuity (BCVA)
Mean change in BCVA using Snellen eye charts
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.
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
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
Time to resolution of anterior chamber (AC) cells and/or AC flare
Time to resolution of anterior chamber (AC) cells and/or AC flare
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)
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.).
Incidence and severity of adverse events
Incidence and severity of adverse events

Full Information

First Posted
October 26, 2021
Last Updated
November 9, 2021
Sponsor
Brian Jerkins, MD
Collaborators
Ocular Therapeutix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05116345
Brief Title
DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures
Acronym
DEXTenSiVe
Official Title
DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brian Jerkins, MD
Collaborators
Ocular Therapeutix, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma Following Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DEXTENZA
Arm Type
Experimental
Arm Description
a single intracanalicular dexamethasone (0.4 mg) insert
Arm Title
Topical Dexamethasone Treatment
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
DEXTENZA
Other Intervention Name(s)
Dexamethasone (0.4mg) Insert
Intervention Description
Intracanalicular Dexamethasone ophthalmic insert (0.4mg)
Intervention Type
Drug
Intervention Name(s)
Topical Dexamethasone
Intervention Description
topical dexamethasone drops
Primary Outcome Measure Information:
Title
Mean change in intraocular pressure (IOP)
Description
mean change in intraocular pressure (IOP) from day of surgery and proportion of eyes requiring additional topical dexamethasone or anti-metabolite therapy over time
Time Frame
From baseline through month 6
Secondary Outcome Measure Information:
Title
Mean change in best corrected visual acuity (BCVA)
Description
Mean change in BCVA using Snellen eye charts
Time Frame
From baseline through month 6
Title
Mean change in Visual Field (MD)
Description
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.
Time Frame
From baseline through month 6
Title
Conjunctival healing outcomes as defined by proportion of eyes requiring needling intervention associated with scar/fibrin development
Description
Conjunctival healing outcomes as defined by proportion of eyes requiring needling intervention associated with scar/fibrin development
Time Frame
From baseline through month 6
Title
Proportion of eyes with absence of anterior chamber (AC) cells (score of 0) as measured by the Standardization of Uveitis Nomenclature (SUN) scale
Description
Proportion of eyes with absence of anterior chamber (AC) cells (score of 0) as measured by the Standardization of Uveitis Nomenclature (SUN) scale
Time Frame
From baseline through month 6
Title
Time to resolution of anterior chamber (AC) cells and/or AC flare
Description
Time to resolution of anterior chamber (AC) cells and/or AC flare
Time Frame
From baseline through month 6
Title
Proportion of eyes with absence of pain as measured by pain scale of 1-10 (pain score of 0 = absence)
Description
Proportion of eyes with absence of pain as measured by pain scale of 1-10 (pain score of 0 = absence)
Time Frame
From baseline through month 6
Title
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.).
Description
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.).
Time Frame
From baseline through month 6
Title
Incidence and severity of adverse events
Description
Incidence and severity of adverse events
Time Frame
From baseline through month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Jerkins, MD
Phone
901-338-1022
Email
bjerkins@uthsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Breia N. Dooley, MA
Phone
901-448-3269
Email
bdooley3@uthsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Jerkins, MD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Eye Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Jerkins, MD
Phone
901-338-1022
Email
bjerkins@uthsc.edu
First Name & Middle Initial & Last Name & Degree
Breia N. Dooley, MA
Phone
901-448-3269
Email
bdooley3@uthsc.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
19084273
Citation
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.
Results Reference
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PubMed Identifier
32700064
Citation
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.
Results Reference
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DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures

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