Sustained Release Dexamethasone for Macular Pucker

Overseen By Jamie White, Bachelors

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Kovach Eye Institute

Must not be taking: Immunosuppressants, Oral steroids

Disqualifiers: Pregnancy, Infectious disease, 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: 1

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment called DEXTENZA, which slowly releases dexamethasone, a type of steroid. It aims to help people with macular pucker, a condition where a layer forms on the eye's retina, causing vision problems. Participants will receive either the new treatment, known as the Dexamethasone Intracanalicular Insert, or a standard eye drop treatment after undergoing eye surgery to remove the layer. The trial seeks individuals with macular pucker and retinal swelling who are scheduled for eye surgery. As a Phase 4 trial, this research involves an FDA-approved treatment to understand its benefits for more patients.

What is the safety track record for these treatments?

Research has shown that the DEXTENZA dexamethasone insert is generally safe. In past studies, it effectively reduced inflammation after eye surgeries. Most patients experienced no major side effects. However, about 20% of patients reported minor issues, such as bleeding in the eye. The FDA has approved this treatment for other uses, indicating a strong safety record. Overall, the insert is well-tolerated, with few serious side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for macular pucker, like topical prednisolone acetate, require regular application and can be inconvenient for patients. However, the Dexamethasone Intracanalicular Insert, a key focus of current research, provides a new delivery method that stands out. This insert releases medication slowly over time, potentially reducing the need for frequent dosing and improving patient compliance. Researchers are excited about this treatment because it offers a sustained release of medication, potentially leading to better and more consistent outcomes for those undergoing vitrectomy with internal limiting membrane peel.

What evidence suggests that this trial's treatments could be effective for macular pucker?

Research shows that the Dexamethasone intracanalicular insert, known as DEXTENZA, helps control inflammation and pain after eye surgery. Previous studies have demonstrated its safety and effectiveness in reducing post-surgical swelling. In this trial, some participants will receive DEXTENZA, which has reduced eye pain and swelling, easing recovery. This small insert, placed in the eye, slowly releases medication over time, providing consistent relief. Already approved for other eye conditions, this treatment is expected to help with macular pucker after surgery. Other participants in this trial will receive topical Prednisolone Acetate 1%, another treatment option under study for its effectiveness in managing post-surgical inflammation. ^{1 2 3 5 6}

Who Is on the Research Team?

Saad Ahmad, MD

Principal Investigator

Kovach Eye Institute

Are You a Good Fit for This Trial?

Adults over 18 with symptomatic macular pucker and retinal edema who are scheduled for a specific eye surgery (vitrectomy with membrane peel) can join. They must be able to attend clinic visits, follow study procedures, and sign consent. Excluded are pregnant women, those with active infections or blocked tear ducts in the affected eye, allergies to dexamethasone or prednisolone, or on certain immune treatments.

Inclusion Criteria

I am scheduled for eye surgery to remove the vitreous gel and peel the inner layer.

Willing and able to sign the informed consent form

Willing and able to comply with clinic visits and study related procedures

Exclusion Criteria

Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)

Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

I am currently taking immunosuppressants or oral steroids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DEXTENZA inserts following vitrectomy with internal limiting membrane peel

8 weeks

Visits on days 1, 7, 30, 60

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone Intracanalicular Insert, 0.4 mg
• Prednisone acetate 1%

Trial Overview The trial is testing DEXTENZA inserts that slowly release dexamethasone after an eye surgery meant to fix a wrinkled retina causing swelling and blurred vision. It's compared against standard anti-inflammatory eye drops (Prednisone acetate). The goal is to see if DEXTENZA better reduces pain, inflammation, and swelling.

How Is the Trial Designed?

Group I: Topical Prednisolone Acetate 1% Group Experimental Treatment 1 Intervention

Patients undergoing vitrectomy with internal limiting membrane peel

Group II: Second DEXTENZA Group Experimental Treatment 1 Intervention

Patients undergoing vitrectomy with internal limiting membrane peel

Group III: DEXTENZA Group Experimental Treatment 1 Intervention

Patients undergoing vitrectomy with internal limiting membrane peel

Who Is Running the Clinical Trial?

Kovach Eye Institute

Lead Sponsor

Trials

2

Recruited

260+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8455509/

Dexamethasone Sustained-Release Intracanalicular Insert for ... The dexamethasone intracanalicular insert provided excellent safety and efficacy in control of postoperative inflammation following PPV in this retrospective ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04501367

Study Details | NCT04501367 | Assessing the Efficacy and ... Study Overview. Brief Summary. Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/490316

Assessing the Efficacy and Safety fo DEXTENZA ... Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) for the Treatment of Pain, Inflammation, and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9749497/

Retrospective Study of a Sustained-Release ... Dextenza has been shown to safely decrease ocular inflammation and pain post operatively, and could provide a more consistent, reliable method ...

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

Dextenza (dexamethasone ophthalmic insert) 0.4mg for ... determined this would be reviewed as efficacy supplement. This supplement includes safety and efficacy data from CLN-Protocol-0050 “A ...

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

Dexamethasone Ophthalmic Implant (Ozurdex) and Insert ... Conjunctival hemorrhage occurred in 85 patients (20 %). Ozurdex is the first FDA-approved therapy for ME related to retinal vein occlusion. The proposed benefit ...