DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia

Study Overview
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Brief Summary
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The Tender Study is a prospective, open-label, single-center, randomized, investigator-initiated clinical study seeks to investigate the safety and efficacy of the DEXTENZA insert in pediatric patients following retinal surgery or laser treatment under anesthesia.

Detailed Description
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The study aims to enroll 30 pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia. Patients in each treatment group (surgery or laser) will be randomized 2:1 at the time of surgery/laser to receive either: Treatment Arm: Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively, or Control Arm: Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QUID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28. Each treatment group (surgery or laser) will include 15 patients total, 10 receiving Dextenza and 5 receiving the control drug. Drops for dilation and antibiotic coverage will be used as clinically indicated in all groups throughout the study period. Follow up will occur at post-op day 1, 7, 28/30 and 45 ( +/- three days for all post-operative timepoints).

Official Title
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The Evaluation of the Safety and Efficacy of Sustained Release Dexamethasone Intracanalicular Insert (DEXTENZA) in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia (TENDER)

Conditions
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Vitreoretinopathy, Coats' Disease, Exudative Retinopathy, Lattice Degeneration, Retinal Hole, Sickler's Syndrome, Retinal Detachment Rhegmatogenous, Retinal Detachment Exudative, Retinal Detachment Traction

Intervention / Treatment
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* Drug: Dextenza 0.4Mg Ophthalmic Insert
* Drug: Pred Forte


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia for a variety of visual conditions. These conditions and procedures include but are not limited to: Conditions: Familial Exudative Vitreoretinopathy Coats' Disease Exudative Retinopathy Lattice degeneration Retinal holes Sickler's syndrome Retinal detachment, rhegmatogenous Retinal detachment, exudative Retinal detachment, tractional Procedures Laser photocoagulation Cryotherapy Retinal detachment repair with scleral buckle and cryotherapy Retinal detachment repair with vitrectomy Written informed consent from parent/legal guardian Exclusion Criteria: Preprocedural Active or history of chronic or recurrent inflammatory eye disease in either eye Any patient of reproductive potential that has a positive pregnancy test during pre-procedural testing Active or history of increased ocular pressure Patients with active corneal, conjunctival, and canalicular infections Patients with punctal stenosis or other punctal anatomical abnormalities that would not be conducive with device insertion Nasolacrimal duct obstruction Laser or incisional ocular surgery during the study period and 6 months prior in the study eye current use of systemic or topical steroids or NSAIDS on a regular basis History of autoimmune disease that may interfere with treatment/outcomes Ocular pain at the time of screening Known malignancy Current use of cyclosporin or a TNF blocker Ocular hypertension IOP >25, actively taking medications for ocular hypertension, any history of IOP spikes in either including steroid associated IOP elevation Congenital ocular lid and tear duct system abnormalities (e.g. congenital ectropion/entropion, trichiasis) Evidence of acute external ocular infection of the study eye Active or history of HSV Previous trauma causing deformity Previous enrollment or current enrollment with another clinical trial within the last 30 days that may interfere with treatment Known allergies to product under investigation Inability to engage in VA testing Investigator determines that the candidate is not eligible for participation based on clinical or historical factors that would interfere with treatment or impact patient safety not specified above Current artificial tear use >4x daily Current use of any topical ocular drops Anyone who, in the opinion of the investigator, would not be a good candidate for the study. Intraoperatively Multiple procedures required Complication occurs that surgeon determines makes the patient ineligible for study inclusion Unsuccessful dilation of the punctum to 0.7mm when dilation attempted during the exam under anesthesia, if it is decided that periocular Kenalog injection is indicated this patient fails screen and will no longer be eligible for the study

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: The study aims to enroll 30 pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia. Patients in each treatment group (surgery or laser) will be randomized 2:1 at the time of surgery/ laser to receive either the Dextenza insert or the Control (Prednisolone Acetate 1%) steroid drops tapered for 28 days post-operatively.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively | Drug: Dextenza 0.4Mg Ophthalmic Insert<br>* DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use<br>|
| Active Comparator: Control Arm<br>Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QUID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28. | Drug: Pred Forte<br>* To treat perioperative ocular inflammation and pain;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as measured by the FLACC pain scale | The Face, Legs, Activity, Cry and Consolability (FLACC) scale is an observational scale. comprised five behavioural indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10. A lower score indicates minimal to no pain while high scores indicate moderate to severe discomfort. | up to Day 45 post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Adverse events are addressed/ assessed at each visit | up to Day 45 post-op | 
| Severity of Adverse Events | Adverse events are addressed/ assessed at each visit | up to Day 45 post-op | 
| Degree of inflammation (AC cell count) | Inflammation is evaluated at each visit during the slit lamp and fundus exam as measured by the ocular inflammation grading scale | up to Day 45 post-op | 
| Resolution of inflammation or less cell on follow up post op exams | Inflammation is evaluated during slit lamp and fundus exams during each post-op visit | up to Day 45 post-op | 
| Resolution of pain | This will be measured by using the FLACC Pain Rating Scale. The Face, Legs, Activity, Cry and Consolability (FLACC) scale is an observational scale comprised five behavioural indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10 | up to Day 45 post-op | 
| Ratio of Intraocular pressure increase with insert | Intraocular pressure is assessed at each visit | up to Day 45 post-op | 
| Percentage of patients with rebound inflammation from baseline through post-op care | Level of inflammation is evaluated at each post-op visit during slip lamp and fundus exams | up to Day 45 post-op | 
| Percentage of patients that were given supplementary prednisolone drops | Supplemental treatment and additional drops needed will be documented at each subsequent visit | up to Day 45 post-op | 
| The number of drops needed in these patients | Supplemental treatment and additional drops needed will be documented at each subsequent visit | up to Day 45 post-op | 
| Mean change in Best Corrected Visual Assessment (BCVA) | Determined by using either ETDRS or HOTV chart testing depending on age. | up to Day 45 post-op | 
| Caregivers Treatment Adherence | Documented at each subsequent visits and with the primary caregiver satisfaction survey at Day 45. This is a subjective survey for each participants' family. | up to Day 45 post-op |