Dextenza for Post-Retinal Surgery Care in Children

Recruiting in Palo Alto (17 mi)

Overseen by Lejla Vajzovic, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Dextenza 0.4Mg Ophthalmic Insert for post-retinal surgery care in children?

Research shows that Dextenza, a sustained-release insert, has been effective in reducing the need for additional steroid drops after cataract surgery in children, suggesting it may help manage inflammation and pain after retinal surgery as well. ^{1 2 3 4 5}

Is Dextenza safe for use in children after eye surgery?

Dextenza, a sustained-release dexamethasone insert, has been used in children after cataract surgery and is generally safe, though some children experienced increased eye pressure and needed additional medication. It helps reduce the need for steroid eye drops after surgery. ^{1 2 3 5 6}

How is the drug Dextenza different from other treatments for post-retinal surgery care in children?

Dextenza is unique because it is a small insert placed in the eye that slowly releases medication over time, reducing the need for frequent eye drops. This makes it easier for children to adhere to their treatment plan and helps manage pain and inflammation after surgery. ^{1 2 4 5 7}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Dextenza 0.4Mg Ophthalmic Insert (Ophthalmic Insert)
• Pred Forte (Corticosteroid)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Duke Eye Center Durham, NC

Who Is Running the Clinical Trial?

Lejla Vajzovic, MD, FASRS Lead Sponsor

Duke University Lead Sponsor

References

1. New Zealand 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. [2022] The dexamethasone 0.4mg intracanalicular insert (Dextenza, Ocular Therapeutix, Bedford, MA) is approved for control of postoperative pain and inflammation following ocular surgery. This study compared pain and inflammation resolution following phacoemulsification in eyes that received the insert immediately postoperatively versus the next day.

2. United States pubmed.ncbi.nlm.nih.gov

A sustained-release intracanalicular dexamethasone insert (Dextenza) for pediatric cataract surgery. [2021] We assess the outcomes of a sustained-release intracanalicular dexamethasone insert (Dextenza) in the treatment of postoperative ocular inflammation in children undergoing cataract surgery. Seventeen eyes of 17 children were analyzed. The anterior chamber was clear in 18% of eyes at 1-2 weeks after surgery. A spike in intraocular pressure requiring intervention was observed in 18% of eyes. Rescue medications using topical steroids were required in 29% of eyes. Our initial experience suggests that the dexamethasone insert reduced or eliminated the need for postoperative steroid drops.

3. New Zealand 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. [2020] The purpose of this study is to evaluate the patient experience of sustained release dexamethasone intracanalicular insert (Dextenza™) following cataract surgery as part of a Phase III clinical trial program.

4. New Zealand pubmed.ncbi.nlm.nih.gov

Dexamethasone Sustained-Release Intracanalicular Insert for Control of Postoperative Inflammation After Pars Plana Vitrectomy. [2022] Label="PURPOSE" NlmCategory="OBJECTIVE">To evaluate the safety and efficacy of a dexamethasone sustained-release intracanalicular insert (DII) (Dextenza&#174; Ocular Therapeutix, Inc., Bedford, MA) for control of inflammation and pain after pars plana vitrectomy (PPV) compared to standard topical steroid therapy.

5. New Zealand 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. [2020] Inflammation and pain are two prevalent findings after ocular surgery. Corticosteroids are widely administrated as a core treatment to control post-surgical inflammation and pain. Improper patient adherence to post-operative eye drop regimens, limited bioavailability of topical eye drops, and the negative impact of preservatives used in many of these eye drops, has made a strong case for novel therapies in the treatment of post-operative pain and inflammation. This review of the literature will focus on the role of intracanalicular sustained-release dexamethasone (Dextenza, Ocular Therapeutix, Bedford, MA, USA) for the management of ocular inflammation and pain.

6. India pubmed.ncbi.nlm.nih.gov

Fractured dexamethasone implant (OZURDEX®) following intravitreal injection. [2021] Dexamethasone implant (Ozurdex™) is a relatively safe medication with few adverse events can happen. We demonstrate clinical course and images of a rare case of fractured intravitreal Ozurdex™ implant that observed immediately following injection and its final outcome.

7. New Zealand pubmed.ncbi.nlm.nih.gov

Dexamethasone Intracanalicular Insert: A Review in Treating Post-Surgical Ocular Pain and Inflammation. [2023] Dextenza&#174;, an intracanalicular insert that is placed into the lower punctal opening of the eye, gradually releases dexamethasone for up to 30&#160;days to alleviate pain and inflammation associated with ophthalmic surgery. A significantly higher proportion of patients treated with the dexamethasone intracanalicular insert than with the placebo insert had no pain at day 8 (co-primary endpoint, 7&#160;days post-operation) across three pivotal phase III trials, and the inflammation co-primary endpoint (absence of anterior chamber cells) at day 14 (13&#160;days post-operation) was met in two of three trials. Overall, the dexamethasone intracanalicular insert was effective and generally well tolerated for the treatment of post-surgical ocular pain and inflammation following cataract surgery. As low patient adherence is an issue for topical ophthalmic anti-inflammatory medications, the convenience (ease of insertion, single application with no patient input and typically no removal required) of the dexamethasone intracanalicular insert makes it a promising emerging option for the treatment of ocular inflammation and pain following ophthalmic surgery.