DEXTENZA for the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vitreo-Retinal Surgery

Intervention / Treatment
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* Drug: Dextenza 0.4Mg Ophthalmic Insert
* Drug: Topical Prednisolone


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 Pre-surgery Dextenza insert<br>Ten patients will receive the dexamethasone intracanalicular insert pre-operatively (1 week to 1 days prior to vitreo-retinal surgery). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops. | Drug: Dextenza 0.4Mg Ophthalmic Insert<br>* The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.<br>|
| Experimental: Group 2 Surgery Day Dextenza insert<br>Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops. | Drug: Dextenza 0.4Mg Ophthalmic Insert<br>* The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.<br>|
| Experimental: Group 3 Post op Day 1 Dextenza insert<br>Ten patients will receive DEXTENZA insert Day 1 post-operatively. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops | Drug: Dextenza 0.4Mg Ophthalmic Insert<br>* The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.<br>|
| Active Comparator: Group 4 Topical steroid<br>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. | Drug: Topical Prednisolone<br>* Standard of care topical drop treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean cells as assessed by investigator in anterior chamber of the study eye | As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+) | Assessed at Day 14 | 
| Mean pain as reported by subject in the study eye: Visual Analog Scale | As measured by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale) | Assessed at Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean anterior chamber flare | As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+) | Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56 | 
| Time to absence of cells | As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+) | Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56 | 
| Time to absence of pain | As measure by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale) | Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56 | 
| Proportion of rescue treatment | As measure by Concomitant Medications as rescue therapy | Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56 | 
| Assessment of Dextenza ease of insertion | As measured by Ease of Use Survey (0=very easy to 10=very hard) | Assessed at Day 1 |