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

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. ^{1 2 3 4 5}

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. ^{2 3 4 5 6}

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. ^{1 2 3 7 8}

Research Team

Katherine Talcott, M.D.

Principal Investigator

Cole Eye Institute, Cleveland Clinic

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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

References

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

A sustained-release intracanalicular dexamethasone insert (Dextenza) for pediatric cataract surgery. [2021]

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]

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

Intracapsular dexamethasone implant in patients undergoing phacoemulsification and intraocular lens implantation. [2019]

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

Surgical Management of Complications after Dexamethasone Implant. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Fractured dexamethasone implant (OZURDEX®) following intravitreal injection. [2021]

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

Accidental injections of dexamethasone intravitreal implant (Ozurdex) into the crystalline lens. [2022]

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]

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

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