Dexamethasone Insert vs Steroid Drops for Postoperative Inflammation

Recruiting in Palo Alto (17 mi)

Overseen by Rishi Singh, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: The Cleveland Clinic

Must not be taking: Narcotics, NSAIDs, Steroids, others

Disqualifiers: Glaucoma, Diabetes, Pregnancy, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group. Patients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications before participating. You must not have used NSAIDs (non-steroidal anti-inflammatory drugs) within 7 days before the procedure or steroids within 14 days before the procedure.

What data supports the effectiveness of the drug Dexamethasone Ophthalmic Insert for reducing postoperative inflammation?

Research shows that the dexamethasone insert (Dextenza) is effective in controlling postoperative pain and inflammation after eye surgery, reducing or eliminating the need for additional steroid drops in many cases.

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Is the dexamethasone insert generally safe for humans?

Dexamethasone inserts, like Ozurdex and Dextenza, are generally considered safe, but there can be rare complications such as fractures of the implant or accidental injections into the wrong part of the eye. These issues are uncommon and usually manageable with medical intervention.

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How does the dexamethasone insert differ from steroid drops for treating postoperative inflammation?

The dexamethasone insert is a small device placed in the eye that slowly releases medication over time, reducing the need for frequent eye drops. This method improves convenience and ensures consistent medication delivery, which can be challenging with traditional steroid drops that require regular application.

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Eligibility Criteria

Adults over 18 needing vitreoretinal surgery for macular hole, epiretinal membrane removal, or vitreomacular traction can join. Excluded are those with certain eye conditions, recent other surgeries or clinical trial participation, ongoing narcotic use, uncontrolled diseases like diabetes, known drug allergies, pregnancy/nursing status or specific glaucoma history.

Inclusion Criteria

I am over 18 years old.

I am scheduled for eye surgery to fix a macular hole, remove an epiretinal membrane, or address vitreomacular traction.

Exclusion Criteria

I experience eye pain in the study eye.

You are allergic to NSAIDs, steroids, or any part of the study medication.

I have used steroids in the past 14 days.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Post-operative Care

Participants undergo vitreoretinal surgery and receive either a dexamethasone insert or topical steroid drops

1 day

1 visit (in-person)

Post-operative Treatment

Participants receive either a continuous release dexamethasone insert or daily topical steroid drops for inflammation and pain management

4 weeks

Follow-up visits on days 1, 3, 7, 14, and 21

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain and visual acuity

4 weeks

Participant Groups

The study compares two treatments post-vitreoretinal surgery: an intracanalicular dexamethasone insert versus topical steroid drops. It aims to assess inflammation control on days 1, 7, 14 and 21 after the procedure in a randomized setup.

Group I: Intracanalicular dexamethasone insert group Experimental Treatment 1 Intervention

This arm will receive the DEXTENZA® insert within minutes after the completion of the surgery.

Group II: Topical steroid drop group Active Control 1 Intervention

This arm will receive the prescription for daily prednisolone acetate 1% eye drops 4 times a day for the first week following the procedure, starting on the day of surgery.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cole Eye Institute, Cleveland Clinic Cleveland, OH

Who Is Running the Clinical Trial?

The Cleveland Clinic Lead Sponsor

Ocular Therapeutix, Inc. Industry Sponsor

References

1. 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.

2. 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.

3. Brazil pubmed.ncbi.nlm.nih.gov

Intracapsular dexamethasone implant in patients undergoing phacoemulsification and intraocular lens implantation. [2019] To relate the outcomes of 7 eyes of 7 patients in which a dexamethasone 0.7 mg implant (Ozurdex(®)) was placed inside the capsule bag after phacoemulsification and intraocular lens (IOL) implantation and compare with the fellow eyes, that were operated by the same technique and received dexamethasone eyedrops in the post-operatory.

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

Surgical Management of Complications after Dexamethasone Implant. [2022] To report surgical management of ocular complications occurred after dexamethasone (DEX) implant (Ozurdex®) injection.

5. 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.

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

Accidental injections of dexamethasone intravitreal implant (Ozurdex) into the crystalline lens. [2022] To describe the side effects and management after inadvertent injection of a dexamethasone implant (Ozurdex) into the crystalline lens.

7. 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.

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

Dexamethasone Intracanalicular Insert: A Review in Treating Post-Surgical Ocular Pain and Inflammation. [2023] Dextenza®, an intracanalicular insert that is placed into the lower punctal opening of the eye, gradually releases dexamethasone for up to 30 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 days post-operation) across three pivotal phase III trials, and the inflammation co-primary endpoint (absence of anterior chamber cells) at day 14 (13 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.