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

NCT ID: NCT05620901

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-02-24

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively

Group Type: EXPERIMENTAL

Dextenza 0.4Mg Ophthalmic Insert

Intervention Type: DRUG

DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use

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.

Group Type: ACTIVE_COMPARATOR

Pred Forte

Intervention Type: DRUG

To treat perioperative ocular inflammation and pain;

Interventions

Dextenza 0.4Mg Ophthalmic Insert

DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use

Intervention Type: DRUG

Pred Forte

To treat perioperative ocular inflammation and pain;

Intervention Type: DRUG

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lejla Vajzovic, MD, FASRS

OTHER

Sponsor Role: lead

Responsible Party

Lejla Vajzovic, MD, FASRS

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lejla Vajzovic, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Eye Center

Locations

Duke Eye Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00107533

Identifier Type: -

Identifier Source: org_study_id