Clinical trial NCT05620901: DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Vitreoretinopathy
Coats' Disease
Exudative Retinopathy
Lattice Degeneration
Retinal Hole
Sickler's Syndrome
Retinal Detachment Rhegmatogenous
Retinal Detachment Exudative
Retinal Detachment Traction
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Pain as measured by the FLACC pain scale
timeFrame: up to Day 45 post-op
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: up to Day 45 post-op
measure: Severity of Adverse Events
timeFrame: up to Day 45 post-op
measure: Degree of inflammation (AC cell count)
timeFrame: up to Day 45 post-op
measure: Resolution of inflammation or less cell on follow up post op exams
timeFrame: up to Day 45 post-op
measure: Resolution of pain
timeFrame: up to Day 45 post-op
measure: Ratio of Intraocular pressure increase with insert
timeFrame: up to Day 45 post-op
measure: Percentage of patients with rebound inflammation from baseline through post-op care
timeFrame: up to Day 45 post-op
measure: Percentage of patients that were given supplementary prednisolone drops
timeFrame: up to Day 45 post-op
measure: The number of drops needed in these patients
timeFrame: up to Day 45 post-op
measure: Mean change in Best Corrected Visual Assessment (BCVA)
timeFrame: up to Day 45 post-op
measure: Caregivers Treatment Adherence
timeFrame: up to Day 45 post-op
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
affiliation: Duke Eye Center
name: Lejla Vajzovic, MD
role: PRINCIPAL_INVESTIGATOR
References: