Dexamethasone Insert vs Steroid Drops for Postoperative Inflammation

Overseen By Angela Meador, MHA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The Cleveland Clinic

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

Disqualifiers: Glaucoma, Diabetes, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to control eye inflammation after certain types of eye surgery. One group will use steroid eye drops, while the other will receive a small insert with dexamethasone (a type of steroid) placed in the eye. The trial aims to determine which method better reduces inflammation after surgery. Candidates may qualify if scheduled for specific eye surgeries, such as those to fix a macular hole or epiretinal membrane, and do not have certain eye conditions or a history of using specific medications. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and it seeks to understand how it benefits more patients.

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 is the safety track record for these treatments?

Research shows that the Dexamethasone eye insert, known as DEXTENZA®, is safe for use in eye surgeries. Previous studies found that patients generally tolerated the insert well, with no major safety issues reported. Common side effects include a temporary increase in eye pressure, a known issue with many eye steroids, but this side effect is usually manageable and not severe.

The eye drop, prednisolone acetate 1%, is also widely used and has a long history of safe use for treating eye inflammation. Like the insert, it can sometimes cause a rise in eye pressure, but this is generally controllable.

Both treatments are well-tolerated and have been used safely in similar situations, providing reassurance about their safety for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike traditional treatments for postoperative inflammation, which typically involve using steroid eye drops like prednisolone acetate multiple times a day, the dexamethasone ophthalmic insert offers a unique delivery method. It’s a tiny insert placed in the tear duct immediately after surgery, providing continuous release of medication without the need for daily drops. This means less hassle for patients and potentially better compliance and consistency in treatment. Researchers are excited because this method could simplify postoperative care and improve outcomes by ensuring a steady dose of medication is delivered directly where it’s needed.

What evidence suggests that this trial's treatments could be effective for postoperative inflammation?

This trial will compare the Dexamethasone Ophthalmic Insert, known as DEXTENZA®, with traditional steroid eye drops, Prednisolone Acetate 1%, for controlling inflammation and pain after eye surgery. Research has shown that DEXTENZA® effectively reduces swelling and manages pain. It is FDA-approved, meeting strict standards for effectiveness. Although less data directly compares it to other treatments, DEXTENZA® is believed to be as effective as traditional steroid eye drops, making it a promising option for recovery after eye surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

Katherine Talcott, M.D.

Principal Investigator

Cole Eye Institute, Cleveland Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone Ophthalmic Insert
• Prednisolone Acetate 1% Oph Susp

Trial Overview 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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Ocular Therapeutix, Inc.

Industry Sponsor

Trials

55

Recruited

6,400+

Published Research Related to This Trial

The dexamethasone 0.7 mg implant (Ozurdex) effectively controlled inflammation after cataract surgery, showing similar visual acuity and intraocular pressure compared to fellow eyes treated with dexamethasone eye drops.

Despite some migration issues with unsutured implants, the overall safety profile was good, with no significant side effects reported, indicating that the implant can be a viable alternative to topical medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracapsular dexamethasone implant in patients undergoing phacoemulsification and intraocular lens implantation. Vianna, LM., Freitas, LL., Nosé, W., et al.[2019]

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]

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]

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]

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]

In two case reports, patients experienced cataracts and increased intraocular pressure after an accidental injection of the dexamethasone implant Ozurdex into the crystalline lens, highlighting potential side effects of this treatment.

Cataract surgery to remove the implant was necessary for both patients to manage these complications and improve their underlying condition, suggesting that prompt intervention is crucial after such an incident.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accidental injections of dexamethasone intravitreal implant (Ozurdex) into the crystalline lens. Coca-Robinot, J., Casco-Silva, B., Armadá-Maresca, F., et al.[2022]

A retrospective case series reported on various surgical techniques used to address ocular complications following dexamethasone (DEX) implant injections, highlighting the need for individualized approaches.

Successful management of complications, including implant migration and acute endophthalmitis, emphasizes the importance of early surgical intervention to preserve eye anatomy and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Management of Complications after Dexamethasone Implant. Sborgia, G., Niro, A., D'Oria, F., et al.[2022]

Citations

1. fda.gov fda.gov/media/187107/download

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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8541700/

Same-Day versus Next-Day Dexamethasone ... The results of this study demonstrate that the dexamethasone 0.4mg intracanalicular insert effectively controlled postoperative inflammation and pain following ...

3. aetna.com aetna.com/cpb/medical/data/700_799/0795.html

Dexamethasone Ophthalmic Implant (Ozurdex) and Insert ... Dexamethasone, a potent corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11114144/

Early Real-World Patient and Staff Experience with an ... DEX has been approved by the US Food and Drug Administration for the treatment of ocular inflammation and pain following ophthalmic surgery and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04200651

NCT04200651 | Prospective Study on DEXTENZA® Safety ... The investigators hypothesize that DEXTENZA® will be as safe as prednisolone acetate 1% drops and as effective at controlling postoperative inflammation ...

6. fda.gov fda.gov/media/187106/download?attachment

Dextenza (dexamethasone ophthalmic insert) 0.4mg for ... Safety data were analyzed using all observed data. ... postoperative pain and inflammation following ocular surgery for pediatric cataract; the.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04200651

NCT04200651 | Prospective Study on DEXTENZA® Safety ... The investigators hypothesize that DEXTENZA® will be as safe as prednisolone acetate 1% drops and as effective at controlling postoperative inflammation ...

8. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=38792&ver=6

LCD - Dexamethasone Intracanalicular Ophthalmic Insert ... Available data indicate punctal occlusion following ophthalmic surgery is associated with improvement in postoperative healing and may prevent post-operative ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/208742s013lbl.pdf

highlights of prescribing information - accessdata.fda.gov Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and ...