A 45 Day, Randomized, Trial of Dextenza in Pediatric Patients Undergoing Retinal Surgeries or Laser Treatments

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duke University
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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