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

NCT05620901 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-04-23

Study results available
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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.

Conditions

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

Interventions

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;

Sponsors & Collaborators

  • Lejla Vajzovic, MD, FASRS

    lead OTHER

Principal Investigators

  • Lejla Vajzovic, MD · Duke Eye Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2025-02-11
Completion
2025-02-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05620901 on ClinicalTrials.gov