Dextenza in the Post-op Management of Vitreoretinal Surgeries

Study Overview
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Brief Summary
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This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group. Patients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.

Detailed Description
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Topical steroids are the current standard of care for managing postoperative pain and inflammation following vitreoretinal surgery. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent nature of application. A corticosteroid insert, placed following surgery, provides the advantages of reliable and continuous drug delivery without the need for patients to adhere to a treatment regimen. Recently, DEXTENZA®, a dexamethasone intracanalicular insert was FDA-approved for the treatment of inflammation and pain following ophthalmic surgery. DEXTENZA® is placed into the canaliculus via the lower punctum and is designed to release steroid medication for 30 days. The data is limited regarding the safety and efficacy of DEXTENZA® for postoperative management of vitreoretinal surgery. Herein, the aim of this study is to assess the management of pain and inflammation following retinal surgery when using a dexamethasone implant compared with topical steroids.

Official Title
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Intracanalicular Dexamethasone Insert for Management of Post-operative Pain and Inflammation in Patients Undergoing Vitreoretinal Surgery

Conditions
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Ocular Inflammation, Vitreoretinal Surgery, Post-operative Pain, Post-Operative Inflammation

Intervention / Treatment
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* Drug: Dexamethasone Ophthalmic Insert
* Drug: Prednisolone Acetate 1% Oph Susp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women >18 years old Planning to undergo vitreoretinal surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction. Exclusion Criteria: Patients undergoing combined cataract or glaucoma procedure, intraocular lens exchange, scleral buckle, and/or implant of a drug delivery system History of complications, trauma, adverse events, disease in nasolacrimal region, including dacryocystitis, canaliculitis in either eye Structural lid abnormalities such as ectropion or entropion in surgical eye Ongoing use of systemic narcotic pain relievers Presence of any intraocular inflammation (cells and flare) in the study eye at screening/baseline Pain score greater than 0 on the ocular pain assessment in the study eye at screening/baseline Active or chronic or recurrent uncontrolled ocular or systemic inflammatory disease, including diabetes Other ocular surgeries or procedures during the study period and/or 6 months prior Intraoperative complications Patients with history of glaucoma (defined as glaucoma requiring 2 or more drops, IOP at baseline greater than 25, or advanced optic nerve cupping). Patients with glaucoma or ocular hypertension controlled with a single drop can be enrolled. Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication. Have used ocular, topical, or systemic NSAIDs within 7 days prior to procedure and during surgery. Use of intracameral or subconjunctival NSAIDs or steroids intraoperatively. Have used topical, ocular, inhaled or systemic steroids within 14 days prior to procedure Are pregnant or nursing/lactating Participation as a subject in any clinical study within the 30 days prior to randomization. Surgeries using 20 gauge or 23 gauge instruments.

Ages Eligible for Study
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Minimum Age: 18 Years

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracanalicular dexamethasone insert group<br>This arm will receive the DEXTENZA® insert within minutes after the completion of the surgery. | Drug: Dexamethasone Ophthalmic Insert<br>* DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care including topical antibiotics.<br>* Other names: DEXTENZA®;|
| Active Comparator: Topical steroid drop group<br>This arm will receive the prescription for daily prednisolone acetate 1% eye drops 4 times a day for the first week following the procedure, starting on the day of surgery. | Drug: Prednisolone Acetate 1% Oph Susp<br>* Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care including topical antibiotics.<br>* Other names: PRED FORTE®, OMNIPRED®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess control of inflammation following the vitreoretinal surgical procedure. | Percentage of patients with Inflammation following surgery as assessed from 0-4+ cell and flare based on the Standardization of Uveitis Nomenclature [SUN] Working Group grading scheme at day 14 | day 14 following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patient reporting of pain following surgery using visual analog pain scale at days 1, 3, 7, 14, and 21 following surgery. | Pain following surgery will be measured using a scale from 0 to10 (0 = no pain, 10 = severe pain that prevents performing activities of daily living). Higher scores mean a worse outcome. | days 1, 3, 7, 14, and 21 following surgery | 
| Inflammation assessed on Anterior Segment OCT by masked grading at days 1, 7, 14, and 21 following surgery. | Anterior segment will be assessed using a continuous variable (cells/mm3). | days 1, 7, 14, and 21 following surgery | 
| Mean change in Best Corrected Visual Acuity (BCVA) from baseline to day 21 following surgery. | BCVA was assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) method. | day 21 following surgery | 
| % of patients with rebound inflammation defined as a two-step worsening of inflammation by SUN grading. |  | day 21 following surgery | 
| % of patients receiving rescue treatment. |  | days 1, 7, 14, and 21 following surgery | 
| % of patients with postoperative management via telephone or electronic messaging |  | day 21 following surgery | 
| The incidence and severity of ocular and non-ocular adverse events (AEs) and serious AEs between arms. |  | day 21 following surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexamethasone insert, Ocular Inflammation, Post-Operative Inflammation, Post-operative Pain