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Dexamethasone Insert vs Steroid Drops for Postoperative Inflammation

Phase 4

Recruiting

Led By Rishi Singh, M.D.

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planning to undergo vitreoretinal surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.

Be older than 18 years old

Must not have

Pain score greater than "0" on the ocular pain assessment in the study eye at screening/baseline

History of complications, trauma, adverse events, disease in nasolacrimal region, including dacryocystitis, canaliculitis in either eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1, 3, 7, 14, and 21 following surgery

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the efficacy of two treatments for inflammation following vitreoretinal surgery. One group will receive a dexamethasone insert and the other group will receive topical steroid drops.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include discomfort at the insertion site for Dextenza (dexamethasone insert), increased eye pressure which could lead to glaucoma if not monitored and managed properly; Prednisolone may cause burning/stinging upon application and potential increase in intraocular pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I experience eye pain in the study eye.

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I have had issues or diseases in my tear duct area.

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My eye has signs of inflammation.

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My eyelid turns inward or outward due to its structure.

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I have used NSAID eye drops, creams, or pills within the last week and during surgery.

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I have had surgery with small instruments.

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I am having eye surgery for cataract, glaucoma, lens exchange, or a drug implant.

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I do not have uncontrolled eye or body inflammation, including diabetes.

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I have had complications during surgery.

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I have used NSAIDs or steroids in my eye during surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 3, 7, 14, and 21 following surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 3, 7, 14, and 21 following surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 3, 7, 14, and 21 following surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess control of inflammation following the vitreoretinal surgical procedure.

Secondary study objectives

Inflammation assessed on Anterior Segment OCT by masked grading at days 1, 7, 14, and 21 following surgery.

Mean change in Best Corrected Visual Acuity (BCVA) from baseline to day 21 following surgery.

The patient reporting of pain following surgery using visual analog pain scale at days 1, 3, 7, 14, and 21 following surgery.

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intracanalicular dexamethasone insert groupExperimental Treatment1 Intervention

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

Group II: Topical steroid drop groupActive Control1 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.

0 / 11Eligibility criteria met