Dextenza for Keratoconus

Recruiting at 2 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Maanasa Indaram, MD

Must not be taking: Immunosuppressants, Oral steroids

Disqualifiers: Glaucoma, Ocular hypertension, Severe scarring, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 4 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to compare the use of Dextenza, an FDA-approved intracanilular drug-eluting insert that is designed to deliver a tapered dose of dexamethasone to the ocular surface for 30 days, to the standard of care, or the use of a month-long topical prednisolone acetate 1% (PredForte) eye drops starting from four times daily. Following treatment, Dextenza resorbs and exits the nasolacrimal system without the need for removal. Three prior phase 3 clinical trials have demonstrated that Dextenza is equally efficacious to a month-long topical Pred Forte taper in the treatment of postoperative inflammation following cataract surgery. This proposed study strives to demonstrate the non-inferiority of using Dextenza to treat postoperative inflammation following corneal collagen crosslinking compared to standard of care eye drops in a randomized trial. By demonstrating Dextenza's non-inferiority to treatment postoperative inflammation, the investigators hope to provide an alternative modality of treatment to patients who are unable to cooperate with or tolerate postoperative topical eye drop regimens, allowing for improved adherence to necessary therapy and thus improved postoperative outcomes.

Research Team

Maanasa Indaram, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for individuals with Keratoconus, a condition affecting the eye's cornea. Participants should be those who require treatment for inflammation after undergoing corneal collagen crosslinking surgery. The study seeks people who may struggle with standard postoperative eye drop treatments.

Inclusion Criteria

The thickness of the center of my cornea is at least 400 microns.

I need general anesthesia for my procedure.

I am 13 or older with worsening keratoconus and scheduled for a specific corneal treatment.

Exclusion Criteria

My nasolacrimal duct size is either below 0.4 mm or at least 1.0 mm.

I have had acute hydrops in my treated eye.

I do not have narrowing in the area where the device will be placed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Surgical/Insertion

Participants undergo epithelium-off corneal collagen crosslinking surgery and receive either Dextenza insert or topical steroid eye drops

1 day

1 visit (in-person)

Treatment

Participants receive either Dextenza insert, which delivers dexamethasone for 30 days, or topical steroid eye drops for 4 weeks

4 weeks

No additional visits required for Dextenza; regular administration for eye drops

Follow-up

Participants are monitored for safety and effectiveness, including assessments of corneal haze, ocular pain, and other outcomes

6 months

9 visits (in-person)

Treatment Details

Interventions

• Dextenza

Trial Overview The trial is testing Dextenza, an FDA-approved insert that releases dexamethasone into the eye over 30 days, against traditional prednisolone acetate (PredForte) eye drops. It aims to show that Dextenza can effectively reduce post-surgery inflammation without being inferior to the usual eyedrop regimen.

Participant Groups

Group I: Dextenza insert Experimental Treatment 1 Intervention

This is a prospective, open-label, single-center, randomized, investigator-sponsored clinical study to compare dexamethasone intracanalicular insert and corticosteroid drops for post-treatment in patients undergoing epithelium-off corneal collagen cross linking surgery. The participant's worse eye will be randomized to one of the two treatments, and the fellow eye will receive the alternate treatment when undergoing the procedure at a subsequent date at least three weeks later. There will be a baseline/screening visit, a surgical/ insertion visit for each eye, and follow up visits over 6 months, for a total of 10 visits per patient. The study drug, DEXTNZA, is administered during the surgical procedure and the patient does not need to do any additional steps.

Group II: topical prednisolone acetate 1% (PredForte) eye drops Active Control 1 Intervention

This is a prospective, open-label, single-center, randomized, investigator-sponsored clinical study to compare dexamethasone intracanalicular insert and corticosteroid drops for post-treatment in patients undergoing epithelium-off corneal collagen cross linking surgery. The participant's worse eye will be randomized to one of the two treatments, and the fellow eye will receive the alternate treatment when undergoing the procedure at a subsequent date at least three weeks later. There will be a baseline/screening visit, a surgical/ insertion visit for each eye, and follow up visits over 6 months, for a total of 10 visits per patient. The patient will administer the anti-inflammatory steroid drops on the same 4 week post-operative schedule that is commonly used in standard of care. They will do one drop of Pred Forte in the affected eye 4 times a day for a week, 3 times a day for the second week, 2 times a day for the third week, and once a day for the fourth week.

Who Is Running the Clinical Trial?

Maanasa Indaram, MD

Lead Sponsor

Trials

1

Recruited

20+