At a glance
ClinicalIndex Comparison RecordEarly Ph 1Completed· 15 enrolled
Drug / intervention
Dextenza 0.4Mg Ophthalmic Insert +1 moredrug
Likely dose
Dextenza 0.4Mg Ophthalmic Insertfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Early Phase 1 clinical trial evaluating Dextenza 0.4Mg Ophthalmic Insert and Pred Forte for Vitreoretinopathy and 8 related conditions. Completed, enrolled 15 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVitreoretinopathy, Coats' Disease, Exudative Retinopathy, Lattice Degeneration, Retinal Hole, Sickler's Syndrome, Retinal Detachment Rhegmatogenous, Retinal Detachment Exudative, Retinal Detachment Traction
CountriesUnited States
Collaborators--
Timeline
Early Ph 1CompletedFinished
2023202420252026
First PostedNov 2022
Enrollment StartFeb 2023
Primary CompletionFeb 2025
Study CompletionFeb 2025
TodayJul 2026
First PostedNov 17, 2022
Enrollment StartFeb 1, 2023
Primary CompletionFeb 11, 2025
Study CompletionFeb 24, 2025
TodayJul 3, 2026
Enrollment to primary: 2.0 yearsPosted 3.6 years ago
Interventions
Dextenza 0.4Mg Ophthalmic Insertdrug
DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use
Pred Fortedrug
To treat perioperative ocular inflammation and pain;