Dextenza for Keratoconus

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Dextenza, a small insert that releases medicine over time, matches the effectiveness of standard eye drops in reducing eye inflammation after a specific surgery for keratoconus, a condition where the cornea thins and bulges. Instead of using eye drops multiple times a day, Dextenza is inserted once and works for 30 days, making it ideal for those who struggle with a regular eye drop schedule. Individuals with worsening keratoconus undergoing a specific type of eye surgery and requiring general anesthesia might be suitable candidates. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in eye care.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are being treated with immunomodulating agents, immunosuppressants, or oral steroids, you cannot participate in the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Dextenza, a small insert for the eye that releases medication, is generally safe for people. Previous studies found no harmful effects from the steroid it contains. In these studies, patients using Dextenza experienced less pain and swelling after certain eye surgeries. This suggests that the treatment is well-tolerated and could be a safe option for managing inflammation post-surgery. For those considering joining a trial with Dextenza, this safety information may provide reassurance. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for keratoconus involve corticosteroid eye drops, like PredForte, which require patients to follow a detailed daily schedule. However, Dextenza is unique because it offers a new delivery method: an intracanalicular insert that releases dexamethasone directly into the eye. This means patients don't need to worry about applying drops multiple times a day, making the treatment much more convenient. Researchers are excited about Dextenza because it could simplify post-operative care and improve patient adherence, potentially leading to better outcomes.

What evidence suggests that Dextenza might be an effective treatment for keratoconus?

Research has shown that Dextenza, a tiny insert placed in the tear duct, reduces inflammation and pain after surgery. In this trial, participants will receive either the Dextenza insert or standard steroid eye drops, such as Pred Forte, following corneal collagen crosslinking surgery. Earlier studies demonstrated that Dextenza performed as well as these standard steroid eye drops. Patients using Dextenza experienced significant vision improvements without needing to administer eye drops themselves. This treatment is as effective as Pred Forte eye drops for managing inflammation after eye surgeries like cataract removal. The insert releases medication slowly over a month and dissolves on its own, eliminating the need for daily eye drop routines. ^{1 2 3 5 6}

Who Is on the Research Team?

Maanasa Indaram, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04168112

NCT04168112 | Intracanalicular Dexamethasone Insert for ... The goal of this study is to evaluate the efficacy of an intracanalicular dexamethasone insert in reduction of post-CXL pain as compared to routine steroid eye ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37532250/

Intracanalicular dexamethasone insert for post-corneal ... This prospective randomized study investigated the efficacy of a dexamethasone intracanalicular insert on post-CXL pain and inflammation in progressive ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06235567

Dextenza Versus Topical Steroid Eye Drops for ... This proposed study strives to demonstrate the non-inferiority of using Dextenza to treat postoperative inflammation following corneal collagen crosslinking.

4. researchgate.net researchgate.net/publication/372867192_Intracanalicular_Dexamethasone_Insert_for_Post-Corneal_Cross-Linking_Inflammation_and_Pain_-_The_LINK_Study

Intracanalicular Dexamethasone Insert for Post-Corneal ... Results: At 24-month follow-up, the mean corrected distance visual acuity (CDVA) improved from 0.24±0.17 to 0.17±0.11 logMAR in the epi-off group (P=0.032). In ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06235567

Dextenza Versus Topical Steroid Eye Drops for ... This proposed study strives to demonstrate the non-inferiority of using Dextenza to treat postoperative inflammation following corneal collagen crosslinking.

6. summerbreak.ascrs.org summerbreak.ascrs.org/-/media/files/2021-papers/sps-211/72881-linkpptascrs2021.pdf

Intracanalicular Dexamethasone Insert for Post-Corneal ... month-long tapering dose of prednisolone is safe and efficacious. • No patients had any adverse events in relation to dexamethasone intracanalicular insertion, ...