Sustained Release Dexamethasone for Macular Pucker

Recruiting in Palo Alto (17 mi)

Overseen bySaad Ahmad, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Kovach Eye Institute

No Placebo Group

Prior Safety Data

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

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

See 2 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

Treatment Details

Interventions

Dexamethasone Intracanalicular Insert, 0.4 mg (Corticosteroid)
Prednisone acetate 1% (Corticosteroid)

Trial OverviewThe 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

3Treatment groups

Experimental Treatment

Group I: Topical Prednisolone Acetate 1% GroupExperimental Treatment1 Intervention

Patients undergoing vitrectomy with internal limiting membrane peel

Group II: Second DEXTENZA GroupExperimental Treatment1 Intervention

Patients undergoing vitrectomy with internal limiting membrane peel

Group III: DEXTENZA GroupExperimental Treatment1 Intervention

Patients undergoing vitrectomy with internal limiting membrane peel