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

Early Phase 1

Recruiting

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

Interventions: Drug: Dextenza 0.4Mg Ophthalmic Insert
Drug: Pred Forte

Registration Number: NCT05620901

Lead Sponsor: Duke University

Brief Summary: 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: 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:

1. Treatment Arm: Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively, or

2. 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).

Recruitment & Eligibility

Status: RECRUITING

Sex: All

Target Recruitment: 30

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Dextenza 0.4Mg Ophthalmic Insert	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
Control Arm	Pred Forte	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.

Primary Outcome Measures

Name	Time	Method
Pain as measured by the FLACC pain scale	up to Day 45 post-op	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.

Secondary Outcome Measures

Name	Time	Method
Severity of Adverse Events	up to Day 45 post-op	Adverse events are addressed/ assessed at each visit
Resolution of inflammation or less cell on follow up post op exams	up to Day 45 post-op	Inflammation is evaluated during slit lamp and fundus exams during each post-op visit
Degree of inflammation (AC cell count)	up to Day 45 post-op	Inflammation is evaluated at each visit during the slit lamp and fundus exam as measured by the ocular inflammation grading scale
Percentage of patients with rebound inflammation from baseline through post-op care	up to Day 45 post-op	Level of inflammation is evaluated at each post-op visit during slip lamp and fundus exams
Percentage of patients that were given supplementary prednisolone drops	up to Day 45 post-op	Supplemental treatment and additional drops needed will be documented at each subsequent visit
The number of drops needed in these patients	up to Day 45 post-op	Supplemental treatment and additional drops needed will be documented at each subsequent visit
Mean change in Best Corrected Visual Assessment (BCVA)	up to Day 45 post-op	Determined by using either ETDRS or HOTV chart testing depending on age.
Incidence of adverse events	up to Day 45 post-op	Adverse events are addressed/ assessed at each visit
Caregivers Treatment Adherence	up to Day 45 post-op	Documented at each subsequent visits and with the primary caregiver satisfaction survey at Day 45. This is a subjective survey for each participants' family.
Resolution of pain	up to Day 45 post-op	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
Ratio of Intraocular pressure increase with insert	up to Day 45 post-op	Intraocular pressure is assessed at each visit

Trial Locations

Locations (1): Duke Eye Center
🇺🇸
Durham, North Carolina, United States

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

Recruitment & Eligibility

Study & Design

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