Dextenza for Post-Retinal Surgery Care in Children

Overseen By Victoria Griffiths

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: Lejla Vajzovic, MD, FASRS

Must not be taking: Steroids, NSAIDs, Cyclosporin, TNF blockers

Disqualifiers: Inflammatory eye disease, Ocular pressure, Autoimmune disease, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 46

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a small device called Dextenza (an ophthalmic insert) can safely and effectively reduce eye inflammation and pain in children immediately after retinal surgery. Some children will receive Dextenza during their surgery, while others will use standard eye drops for a few weeks afterward. The trial is open to children with retinal conditions such as retinal detachment who are undergoing surgery or laser treatments under anesthesia. As an Early Phase 1 trial, the research aims to understand how Dextenza works in children, offering participants the opportunity to be among the first to benefit from this innovative treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using any systemic or topical steroids, NSAIDs (non-steroidal anti-inflammatory drugs), cyclosporin, TNF blockers, and any topical ocular drops before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Dextenza, a small insert that slowly releases medication, is generally safe for children. It has been used after cataract surgery in kids without major problems. While some children experienced side effects, these were uncommon. Dextenza is already approved for treating eye inflammation and pain after surgery, supporting its safety for these uses.

The current trial is in its early stage, so safety remains a primary focus. Researchers aim to ensure Dextenza's safety for children after retinal surgery. Its existing approval for similar conditions in children adds confidence to its safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Dextenza for post-retinal surgery care in children because it offers a new delivery method that could simplify the recovery process. Unlike the standard treatment, which involves a tapering regimen of prednisolone steroid eye drops over 28 days, Dextenza is an ophthalmic insert placed during surgery. This means patients may not need to manage daily eye drops, potentially improving compliance and comfort. Additionally, Dextenza directly targets ocular inflammation and pain, providing consistent medication release without the hassle of frequent dosing.

What evidence suggests that Dextenza might be an effective treatment for post-retinal surgery care in children?

Research shows that Dextenza, a small eye insert, can reduce pain and swelling after eye surgery. In earlier studies, Dextenza relieved pain within eight days post-surgery. Patients have found this treatment comfortable and easy to use. In this trial, some participants will receive the Dextenza insert intraoperatively for perioperative ocular inflammation and pain, eliminating the need for daily steroid drops post-operatively. Although limited information exists specifically for children after retinal surgery, Dextenza has been successfully used in similar pediatric eye surgeries. Its ability to deliver medicine directly to the eye without daily drops could be especially beneficial for children. ^{2 3 4 6 7}

Who Is on the Research Team?

Lejla Vajzovic, MD

Principal Investigator

Duke Eye Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Written informed consent from parent/legal guardian

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

Exclusion Criteria

Preprocedural exclusion criteria include active or history of chronic or recurrent inflammatory eye disease in either eye, positive pregnancy test during pre-procedural testing for patients of reproductive potential, increased ocular pressure, active corneal, conjunctival, and canalicular infections, punctal stenosis or other punctal anatomical abnormalities, nasolacrimal duct obstruction, recent laser or incisional ocular surgery, regular use of systemic or topical steroids or NSAIDS, history of autoimmune disease, ocular pain at the time of screening, known malignancy, current use of cyclosporin or a TNF blocker, ocular hypertension, congenital ocular lid and tear duct system abnormalities, acute external ocular infection, history of HSV, previous trauma causing deformity, previous or current enrollment in another clinical trial within the last 30 days, known allergies to product under investigation, inability to engage in VA testing, and investigator's discretion based on clinical or historical factors

I was not excluded during surgery due to complications or the need for multiple procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Dextenza insert intraoperatively or Prednisolone forte 1% steroid drops post-operatively for perioperative ocular inflammation and pain

4 weeks

Post-op visits on days 1, 7, 28/30

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events, inflammation, and pain

up to 45 days post-op

Post-op visit on day 45

What Are the Treatments Tested in This Trial?

Interventions

• Dextenza 0.4Mg Ophthalmic Insert
• Pred Forte

Trial Overview

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.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

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

Group II: Control Arm Active Control 1 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.

Who Is Running the Clinical Trial?

Lejla Vajzovic, MD, FASRS

Lead Sponsor

Trials

1

Recruited

30+

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

In a study involving 25 patients who received the sustained release dexamethasone insert (Dextenza™) after cataract surgery, 92% reported high overall satisfaction, highlighting its effectiveness and comfort compared to traditional eye drop therapies.

The insert was deemed very convenient by 96% of participants, with 88% expressing a desire to use it again for future surgeries, indicating a strong preference for this method of drug delivery over conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the patient experience after implantation of a 0.4 mg sustained release dexamethasone intracanalicular insert (Dextenza™): results of a qualitative survey. Gira, JP., Sampson, R., Silverstein, SM., et al.[2020]

The sustained-release dexamethasone insert (Dextenza) was evaluated in 17 children after cataract surgery, showing that only 18% of eyes had a clear anterior chamber at 1-2 weeks post-surgery, indicating limited effectiveness in reducing inflammation.

Despite some benefits, 18% of eyes experienced a spike in intraocular pressure requiring treatment, and 29% needed additional topical steroids, suggesting that while Dextenza may reduce the need for steroid drops, it does not completely eliminate the need for further intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sustained-release intracanalicular dexamethasone insert (Dextenza) for pediatric cataract surgery. Trivedi, RH., Wilson, ME.[2021]

The dexamethasone 0.4mg intracanalicular insert (Dextenza) effectively controls postoperative pain and inflammation after cataract surgery, showing similar outcomes whether placed immediately after surgery or the next day, based on a study of 17 eyes.

No adverse events related to the insert were reported, and all patients experienced resolution of inflammation and minimal pain, indicating the safety and efficacy of this treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Same-Day versus Next-Day Dexamethasone Intracanalicular Insert Administration for Inflammation and Pain Control Following Cataract Surgery: A Retrospective Analysis. Foster, B.[2022]

Dexamethasone implant (Ozurdex™) is generally considered a safe treatment with minimal adverse events, highlighting its favorable safety profile.

The study presents a rare case of a fractured Ozurdex™ implant occurring immediately after injection, providing insights into potential complications and their outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractured dexamethasone implant (OZURDEX®) following intravitreal injection. Aljohani, SM., Al-Shehri, AM., Al-Rubaie, KR.[2021]

The Dextenza® intracanalicular insert, which releases dexamethasone for up to 30 days, significantly reduced post-surgical pain in patients after cataract surgery compared to a placebo, with a notable proportion of patients reporting no pain by day 8.

This insert also effectively managed inflammation, as evidenced by the absence of anterior chamber cells in two out of three pivotal trials, highlighting its potential as a convenient and well-tolerated treatment option for ocular pain and inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone Intracanalicular Insert: A Review in Treating Post-Surgical Ocular Pain and Inflammation. Lee, A., Blair, HA.[2023]

The dexamethasone sustained-release intracanalicular insert (DII) significantly improved the rate of complete anterior chamber cell clearance (ACCC) at postoperative day 7 compared to standard topical steroid therapy, with 65% of patients achieving ACCC in the DII group versus 35% in the topical group (p=0.01).

The DII showed excellent safety, as no patients experienced elevated intraocular pressure (IOP >25 mmHg), while two patients in the topical steroid group did, indicating a favorable safety profile for the DII in managing postoperative inflammation after pars plana vitrectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone Sustained-Release Intracanalicular Insert for Control of Postoperative Inflammation After Pars Plana Vitrectomy. Suñer, IJ., Peden, MC.[2022]

Intracanalicular sustained-release dexamethasone (Dextenza) offers a novel approach to managing post-operative ocular inflammation and pain, addressing issues like patient adherence and the limitations of traditional eye drops.

This method potentially improves bioavailability and reduces the negative effects of preservatives found in many topical treatments, making it a promising alternative for post-surgical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone 0.4mg Sustained-Release Intracanalicular Insert in the Management of Ocular Inflammation and Pain Following Ophthalmic Surgery: Design, Development and Place in Therapy. Brooks, CC., Jabbehdari, S., Gupta, PK.[2020]

Citations

1.

fda.gov

fda.gov/media/187107/download

statistical review and evaluation

For the Phase 3 Study CLN-Protocol-0050, the efficacy of DEXTENZA was evaluated by the primary endpoints: absence of pain at 8 days post-surgery ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05620901

DEXTENZA in Pediatric Patients Following Retinal Surgery ...

The study aims to enroll 30 pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia. Patients in each treatment group ...

3.

withpower.com

withpower.com/trial/early-phase-1-dissociative-disorders-10-2022-d3a55

Dextenza for Post-Retinal Surgery Care in Children

This trial is for children needing retinal surgery or laser treatment under anesthesia. They must have conditions like Retinal Detachment, Lattice Degeneration, ...

4.

fda.gov

fda.gov/media/187106/download?attachment

Dextenza (dexamethasone ophthalmic insert) 0.4mg for ...

Efficacy of DEXTENZA® for the Treatment of Ocular Pain and Inflammation Following Surgery for. Pediatric Cataract”. This pediatric safety ...

5.

dextenza.com

dextenza.com/why-dextenza/

Why Dextenza

Patients reported highly favorable outcomes in comfort, convenience, and satisfaction6. Survey results based on the responses from 201 DEXTENZA patients who ...

6.

fda.gov

fda.gov/media/187107/download?attachment

statistical review and evaluation

Therefore, the data is limited, and the evidence of efficacy was inconclusive for DEXTENZA comparable to PAS for the treatment of ocular.

7.

dextenza.com

dextenza.com/wp-content/uploads/DEXTENZA-Full-Prescribing-Information.pdf

prescribing information

The safety and effectiveness of DEXTENZA for the treatment of ocular inflammation and pain following ophthalmic surgery have been established in pediatric ...