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

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)

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.

Study Overview

• Status: Completed
• Conditions: Coats' Disease; Vitreoretinopathy; Exudative Retinopathy; Lattice Degeneration; Retinal Hole; Sickler's Syndrome; Retinal Detachment Rhegmatogenous; Retinal Detachment Exudative; Retinal Detachment Traction
• Intervention / Treatment: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Pred Forte

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).

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; 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; DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use
Active Comparator: 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 (QID) 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; To treat perioperative ocular inflammation and pain;

What is the study measuring?

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.	Baseline, post-op days 1, 7, 28, and 45

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Adverse events are addressed/ assessed at each visit	Up to post-op day 45
Severity of Adverse Events	Adverse events are addressed/ assessed at each visit	Up to post-op day 45
Ocular 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, which ranges from 0 to 4. A higher score indicates greater inflammation.	Baseline, post-op days 1, 7, 28, and 45
Percentage of Participants With AC (Anterior Chamber) Cell	AC (Anterior Chamber) cell is evaluated during slit lamp and fundus exams during each post-op visit. Resolution defined as AC cell measured at 0 or 0.5 (trace) after surgery.	Post-op days 1, 7, 28, and 45
Number of Participants With 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 of five behavioral indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10, where a higher score indicates greater pain. Resolution of pain is defined as having a nonzero FLACC score at a postoperative visit and a FLACC score of 0 at a following visit.	up to 45 days post-op
Change in Absolute Intraocular Pressure (IOP)	Intraocular pressure is assessed at each visit.	Post-op days 1, 7, 28, and 45
Number of Participants With Rebound Inflammation	Level of inflammation is evaluated at each post-op visit during slip lamp and fundus exams. Rebound inflammation is defined as recurrent AC (Anterior Chamber) cell > 0 or .5 (trace) after initial resolution.	up to 45 days post-op
Number of Treatment Participants Who Were Given Supplementary Prednisolone Drops	Supplemental drops needed will be documented at each subsequent visit.	up to 45 days post-op
Number of Supplemental Drops Needed in Treatment Participants	Supplemental drops needed will be documented at each subsequent visit.	up to 45 days post-op
Median Change in Best Corrected Visual Assessment (BCVA) From Baseline	Determined by using either ETDRS (Early Treatment Diabetic Retinopathy Study) or HOTV chart (uses the letters H, O, T, and V) testing depending on age. Visual Acuities were converted to logMAR scores for statistical analyses.	baseline, post-op days 1, 7, 28, and 45
Caregivers Treatment Adherence	Documented with the primary caregiver satisfaction survey at Day 45. This is a subjective survey for each participants' family. Reported on a Likert scale of 1 to 5, with 1 being strongly disagree and 5 being strongly agree to "I sometimes forget to administer my child's eye drops".	Day 45 post-op

Collaborators and Investigators

• Sponsor: Lejla Vajzovic, MD, FASRS
• Investigators: Principal Investigator: Lejla Vajzovic, MD, Duke Eye Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): February 11, 2025
• Study Completion (Actual): February 24, 2025

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Retinal Diseases; Telangiectasis; Retinal Perforations; Retinal Telangiectasis; Sulfur Compounds; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Benzene Derivatives; Sulfonic Acids; Sulfur Acids; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Calcium Dobesilate; prednisolone acetate
• Other Study ID Numbers: Pro00107533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No