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Ophthalmic Insert

Dextenza for Post-Retinal Surgery Care in Children

Phase < 1

Recruiting

Led By Lejla Vajzovic, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia for a variety of visual conditions including but not limited to Familial Exudative Vitreoretinopathy, Coats' Disease, Exudative Retinopathy, Lattice degeneration, Retinal holes, Sickler's syndrome, Retinal detachment (rhegmatogenous, exudative, tractional), and procedures such as Laser photocoagulation, Cryotherapy, Retinal detachment repair with scleral buckle and cryotherapy, Retinal detachment repair with vitrectomy

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 45 post-op

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates the safety and effectiveness of a medical insert in children who have had eye surgery or laser treatment while under anesthesia.

Who is the study for?

This trial is for children needing retinal surgery or laser treatment under anesthesia. They must have conditions like Retinal Detachment, Lattice Degeneration, and others. Kids can't join if they have eye inflammation history, are pregnant, have increased eye pressure, infections, recent surgeries, use certain drugs or steroids, autoimmune diseases, ocular pain at screening time.

What is being tested?

The study tests the safety and effectiveness of DEXTENZA insert versus Pred Forte in kids after retinal procedures. It's an open-label trial where participants know which treatment they receive; it's also randomized to compare outcomes fairly between the two treatments.

What are the potential side effects?

Possible side effects include increased eye pressure from DEXTENZA or Pred Forte usage. There may be risks of infection or allergic reactions to the medications used in this pediatric population.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is having eye surgery for a serious vision condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 45 post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 45 post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 45 post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Analgesics

Secondary study objectives

Caregivers Treatment Adherence

Cell Count

Incidence of adverse events

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ArmExperimental Treatment1 Intervention

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

Group II: Control ArmActive Control1 Intervention

Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QUID) 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dextenza 0.4Mg Ophthalmic Insert

2020

Completed Phase 4

~210

0 / 1Eligibility criteria met