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: Unknown

60 Participants Needed

Trial Summary

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

Research Team

Saad Ahmad, MD

Principal Investigator

Kovach Eye Institute

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+