Clinical trial NCT04462523: DEXTENZA for the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery
Official title: Open-label, Single -Center, Prospective Study on the Efficacy and Safety of Intracanalicular Dexamethasone Insert 0.4mg (Dextenza) in the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery - The ADHERE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitreo-Retinal Surgery
Lead sponsor: Retina Vitreous Surgeons of Central New York, PC
Sponsor class: NETWORK
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2020-07-08
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy and safety of Dextenza for the treatment of postoperative pain and inflammation following vitreo-retinal surgery

Detailed description: This prospective, single-center, open-label, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing vitro-retinal surgery with the treatment of a dexamethasone intracanalicular insert. All patients in the treatment groups will receive a dexamethasone intracanalicular insert. There will be three experimental groups of patients, varying that time of insertion. Ten patients will receive the dexamethasone intracanalicular insert pre-operatively (1 week to 1 days prior to vitreo-retinal surgery). Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. Ten patients will receive DEXTENZA insert Day 1 post-operatively. Ten patients will be prescribed standard of care ophthalmic drops, Prednisolone Acetate, and no dexamethasone insert (control group). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.

Eligibility criteria: Inclusion Criteria:

* Any adult patient age 18-99 years who is planned to undergo vitreo-retinal surgery (pars plana vitrectomy with or without scleral buckle).
* If both eyes are involved, both eyes would be eligible for the study.
* Willing and able to comply with clinic visits and study related procedures.
* Willing and able to sign the informed consent form.

Exclusion Criteria:

* Patients under age 18.
* Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test).
* Active infectious ocular or systemic disease.
* Patients with active infectious ocular or extraocular disease.
* Patients actively treated with local or systemic immunosuppression
* Use of the following anti-inflammatory or immunomodulating agents (e.g., cyclosporine) systemically, or in the study eye, for the duration of the study (excluding inhalants). Washout periods for medications prior to surgery are as follows:
* Systemic corticosteroids - 2 weeks (see exception 5c)
* Systemic NSAID over 375 mg per day - 2 weeks
* Periocular/intraocular injection of any corticosteroid solution - 4 weeks (see exception 5b)
* Corticosteroid depot/implant in the study eye - 2 months
* Topical ocular corticosteroid - 7 days
* Topical ocular NSAID - 7 days
* Intraoperatively used intraocular steroid (i.e. intravitreal triamcinolone, that is used to transiently highlight the vitreous and removed during vitrectomy) is permissible in study eye.
* Intraoperatively or perioperatively used systemic steroid for the purpose of general anesthesia (as administered by the treating anesthesiologist) is permissible.
* Patients with systemic illness involving abnormalities of the hypothalamic-pituitary-adrenal axis; patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.
* Patients with known hypersensitivity to Dexamethasone.
* Patients with uncontrolled glaucoma.
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.

Primary outcomes:
measure: Mean cells as assessed by investigator in anterior chamber of the study eye
timeFrame: Assessed at Day 14
measure: Mean pain as reported by subject in the study eye: Visual Analog Scale
timeFrame: Assessed at Day 28
Secondary outcomes:
measure: Mean anterior chamber flare
timeFrame: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
measure: Time to absence of cells
timeFrame: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
measure: Time to absence of pain
timeFrame: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
measure: Proportion of rescue treatment
timeFrame: Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56
measure: Assessment of Dextenza ease of insertion
timeFrame: Assessed at Day 1
Other outcomes:
Locations:
city: Liverpool
country: United States
facility: Retina Vitreous Surgeons of Central New York, PC
state: New York
Study officials:
References: