Clinical trial NCT05116345: DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures
Official title: DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Glaucoma Following Surgery
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2021-11-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean change in intraocular pressure (IOP)
timeFrame: From baseline through month 6
Secondary outcomes:
measure: Mean change in best corrected visual acuity (BCVA)
timeFrame: From baseline through month 6
measure: Mean change in Visual Field (MD)
timeFrame: From baseline through month 6
measure: Conjunctival healing outcomes as defined by proportion of eyes requiring needling intervention associated with scar/fibrin development
timeFrame: From baseline through month 6
measure: Proportion of eyes with absence of anterior chamber (AC) cells (score of 0) as measured by the Standardization of Uveitis Nomenclature (SUN) scale
timeFrame: From baseline through month 6
measure: Time to resolution of anterior chamber (AC) cells and/or AC flare
timeFrame: From baseline through month 6
measure: Proportion of eyes with absence of pain as measured by pain scale of 1-10 (pain score of 0 = absence)
timeFrame: From baseline through month 6
measure: 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.).
timeFrame: From baseline through month 6
measure: Incidence and severity of adverse events
timeFrame: From baseline through month 6
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Hamilton Eye Institute
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Brian Jerkins, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.