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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
Must not have
Patient being treated with immunosuppressants and/or oral steroids
Active infectious ocular or extraocular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up as assessed on day of surgery
Awards & highlights
Approved for 60 Other Conditions
Drug Has Already Been Approved
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

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.
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.
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
Select...
I am scheduled for eye surgery to remove the vitreous gel and peel the inner layer.
Select...
I am 18 years old or older.
Select...
I have vision problems due to a wrinkled retina.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently taking immunosuppressants or oral steroids.
Select...
I have an active eye infection.
Select...
My tear duct in one or both eyes is blocked.
Select...
I am currently receiving treatment with immune-boosting drugs for my eye condition.
Select...
I do not have an active infection.
Select...
I am under 18 years old.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change in retina edema
Secondary study objectives
Mean Change in Best- Corrected Visual Acuity (BCVA)
Mean change in Inflammation ( Cell and Flare)
Mean change in pain scores
+1 more

Awards & Highlights

Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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
~0 spots leftby Dec 2024
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