DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia
Completed · Early Phase 1
Conditions studied: Vitreoretinopathy, Coats' Disease, Exudative Retinopathy, Lattice Degeneration, Retinal Hole, Sickler's Syndrome, Retinal Detachment Rhegmatogenous, Retinal Detachment Exudative, Retinal Detachment Traction
In brief
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.
Key facts
- Study ID
- NCT05620901
- Run by
- Lejla Vajzovic, MD, FASRS
- People needed
- 15
- Starts
- 2023-02-01
- Expected to finish
- 2025-02-24
- Last updated by the study team
- 2026-04-23
Who can join
Age: 3 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Duke Eye Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.