60 Participants Needed

Sustained Release Dexamethasone for Macular Pucker

SA
JW
Overseen ByJamie White, Bachelors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel

Who Is on the Research Team?

SA

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
See 1 more

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.
See 6 more

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?
3Treatment groups
Experimental Treatment
Group I: Topical Prednisolone Acetate 1% GroupExperimental Treatment1 Intervention
Group II: Second DEXTENZA GroupExperimental Treatment1 Intervention
Group III: DEXTENZA GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kovach Eye Institute

Lead Sponsor

Trials
2
Recruited
260+
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