NCT05620901

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)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Lejla Vajzovic, MD, FASRS · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Dextenza 0.4Mg Ophthalmic Insert	DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use
DRUG	Pred Forte	To treat perioperative ocular inflammation and pain;

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-02-11
• Completion: 2025-02-24
• First posted: 2022-11-17
• Last updated: 2025-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study