Early Phase 1
N=15
DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia
Vitreoretinopathy · Coats' Disease · Exudative Retinopathy · Lattice Degeneration · Retinal Hole
Bottom Line
View on ClinicalTrials.gov: NCT05620901 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Pain as Measured by the FLACC Pain Scale — 0; 0; 0; 0 score on a scale — p=0.3046
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Dextenza 0.4Mg Ophthalmic Insert (Drug); Pred Forte (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Lejla Vajzovic, MD, FASRS
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain as Measured by the FLACC Pain Scale |
0; 0; 0; 0; 0; 0 | 0.3046 |
| SECONDARY Number of Participants With Adverse Events |
0; 0 | — |
| SECONDARY Severity of Adverse Events |
— | — |
| SECONDARY Ocular Inflammation (AC Cell Count) |
0; 0; 0.5; 0; 0.5; 0 | 0.651 |
| SECONDARY Percentage of Participants With AC (Anterior Chamber) Cell |
60; 100; 82; 100; 100; 100 | — |
| SECONDARY Number of Participants With Resolution of Pain |
5 | — |
| SECONDARY Change in Absolute Intraocular Pressure (IOP) |
0.0; -5.0; 3.0; -2.5; 2.0; 4.5 | — |
| SECONDARY Number of Participants With Rebound Inflammation |
0; 0 | — |
| SECONDARY Number of Treatment Participants Who Were Given Supplementary Prednisolone Drops |
0; 0 | — |
| SECONDARY Number of Supplemental Drops Needed in Treatment Participants |
— | — |
| SECONDARY Median Change in Best Corrected Visual Assessment (BCVA) From Baseline |
0.34; 1.36; -0.08; 0.375; -0.25; 0 | 0.019 sig |
| SECONDARY Caregivers Treatment Adherence |
2.00; 1.50 | 0.809 |
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.
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
Data sourced from ClinicalTrials.gov (NCT05620901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.