Using DEXTENZA to treat pediatric patients after retinal surgery or laser treatment
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)
This study is testing if a new eye insert called DEXTENZA can help kids feel less pain and inflammation after retinal surgery or laser treatment, compared to regular steroid eye drops.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05620901 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of the DEXTENZA insert in pediatric patients who undergo retinal surgery or laser treatment under anesthesia. The study will enroll 30 participants, who will be randomized to receive either the DEXTENZA insert or a standard steroid drop regimen for managing ocular inflammation and pain post-operatively. Follow-up assessments will occur at multiple time points to evaluate outcomes related to inflammation and pain management. The trial aims to determine if DEXTENZA can effectively replace traditional steroid drops in this patient population.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients undergoing routine retinal surgery or laser treatment for conditions like Coats' Disease or retinal detachment.
Not a fit: Patients with active or chronic inflammatory eye diseases or those with a history of increased ocular pressure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for topical steroid drops, simplifying post-operative care for pediatric patients.
How similar studies have performed: While this approach is novel in the pediatric population, similar studies in adults have shown promising results with DEXTENZA for managing ocular inflammation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina
- Duke Eye Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Lejla Vajzovic, MD — Duke Eye Center
- Study coordinator: Victoria Griffiths
- Email: victoria.griffiths@duke.edu
- Phone: +1 919 660 7416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.