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Corticosteroid

Sustained Release Dexamethasone for Macular Pucker

Phase 4

Recruiting

Led By Saad Ahmad, MD

Research Sponsored by Kovach Eye Institute

Eligibility Criteria Checklist

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

Must have

Scheduled vitrectomy and internal limiting membrane peel

Age 18 years and older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up as assessed on day of surgery

Awards & highlights

Study Summary

This trial evaluates the use of DEXTENZA, a sustained release corticosteroid, after vitrectomy and membrane peel surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

DEXTENZA may cause increased pressure inside the eye, cataracts in long-term use, delayed healing of the eyesight problems it's supposed to treat. Prednisone drops might sting when applied and could also raise inner-eye pressure or lead to cataracts.

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 remove the vitreous gel and peel the inner layer.

Select...

I am 18 years old or older.

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I have vision problems due to a wrinkled retina.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ as assessed on days 1, 7, 30, 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~as assessed on days 1, 7, 30, 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and as assessed on days 1, 7, 30, 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change in retina edema

Secondary outcome measures

Mean Change in Best- Corrected Visual Acuity (BCVA)

Mean change in Inflammation ( Cell and Flare)

Mean change in pain scores

+1 more

Trial Design

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kovach Eye InstituteLead Sponsor

1 Previous Clinical Trials

200 Total Patients Enrolled

Saad Ahmad, MDPrincipal InvestigatorKovach Eye Institute

Media Library

Dexamethasone Intracanalicular Insert, 0.4 mg (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04501367 — Phase 4

Vitrectomy Research Study Groups: Topical Prednisolone Acetate 1% Group, DEXTENZA Group, Second DEXTENZA Group

Vitrectomy Clinical Trial 2023: Dexamethasone Intracanalicular Insert, 0.4 mg Highlights & Side Effects. Trial Name: NCT04501367 — Phase 4

Dexamethasone Intracanalicular Insert, 0.4 mg (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04501367 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the DEXTENZA Group been given authorization by the FDA?

"The safety of DEXTENZA Group was determined to be a 3 due to its Phase 4 status, which demonstrates that it has been accepted by the medical community."

Answered by AI

What therapeutic uses is DEXTENZA Group typically employed for?

"DEXTENZA Group can be employed to effectively treat ophthalmia, sympathetic eye infections, and branch retinal vein occlusions of bacterial origins."

Answered by AI

Is the patient intake program for this research still open?

"Affirmative. Clinicaltrials.gov records show that since its launch on April 27th 2021, this trial has been amassing participants with the aim of enlisting 60 individuals from a single facility. The study was recently updated on June 27th 2023."

Answered by AI

What is the capacity for enrolment in this medical experiment?

"Affirmative. Visitors to clinicaltrials.gov can observe that this medical investigation, which was first posted on April 27th 2021, is actively recruiting patients. Approximately 60 individuals need to be enlisted from an individual research site."

Answered by AI