DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia

NCT05620901 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: Pro00107533
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitreoretinopathy; Coats' Disease; Exudative Retinopathy; Lattice Degeneration; Retinal Hole; Sickler's Syndrome; Retinal Detachment Rhegmatogenous; Retinal Detachment Exudative; Retinal Detachment Traction

Outcome Measures

Primary Outcomes (1)

• Pain as Measured by the FLACC Pain Scale

  The Face, Legs, Activity, Cry and Consolability (FLACC) scale is an observational scale. comprised five behavioural indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10. A lower score indicates minimal to no pain while high scores indicate moderate to severe discomfort.

  Baseline, post-op days 1, 7, 28, and 45

Secondary Outcomes (11)

• Number of Participants With Adverse Events

  Up to post-op day 45

• Severity of Adverse Events

  Up to post-op day 45

• Ocular Inflammation (AC Cell Count)

  Baseline, post-op days 1, 7, 28, and 45

• Percentage of Participants With AC (Anterior Chamber) Cell

  Post-op days 1, 7, 28, and 45

• Number of Participants With Resolution of Pain

  up to 45 days post-op

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively

Drug: Dextenza 0.4Mg Ophthalmic Insert

Control Arm

ACTIVE COMPARATOR

Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.

Drug: Pred Forte

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use

Treatment Arm

Pred Forte DRUG

To treat perioperative ocular inflammation and pain;

Control Arm

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

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)

Sponsors & Collaborators

• Lejla Vajzovic, MD, FASRS: lead

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Retinal Telangiectasis; Retinal Perforations

Interventions

Calcium Dobesilate; prednisolone acetate

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Telangiectasis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Lejla Vajzovic, M.D.
• Organization: Duke University

lejla.vajzovic@duke.edu

(919) 668-5316

Study Officials

• Lejla Vajzovic, MD

  Duke Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study aims to enroll 30 pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia. Patients in each treatment group (surgery or laser) will be randomized 2:1 at the time of surgery/ laser to receive either the Dextenza insert or the Control (Prednisolone Acetate 1%) steroid drops tapered for 28 days post-operatively.

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 17, 2022
• Study Start: February 1, 2023
• Primary Completion: February 11, 2025
• Study Completion: February 24, 2025
• Last Updated: April 23, 2026
• Results First Posted: April 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)