Yutiq Steroid Insert for Glaucoma

Overseen By Sarah Jones

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Sanjay Asrani

Must not be taking: Anti-VEGF, Immunosuppressants

Disqualifiers: Infections, HIV, Steroid allergy, others

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

Compensation: Varies

Number of Visits: 13

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for glaucoma, a condition that increases eye pressure. The study examines a steroid insert called Yutiq, used with a glaucoma drainage device during eye surgery, to determine if it can safely reduce scarring and control eye pressure better than surgery alone. The trial suits those scheduled for glaucoma tube implant surgery or combined cataract and glaucoma surgery, excluding individuals with inflammation-related glaucoma or a steroid allergy. As an Early Phase 1 trial, this research aims to understand how this new treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are receiving anti-VEGF therapy in the study eye, you would not be eligible to participate.

What prior data suggests that this treatment is safe for glaucoma patients?

Research has shown that the Yutiq steroid insert is generally safe, particularly for treating eye conditions like uveitis. However, it can sometimes increase eye pressure in certain individuals. Previous studies with similar steroid implants have found them safe and effective for patients with devices that help drain fluid from the eye.

These implants have also been used safely in other eye surgeries. However, they might cause side effects such as cataracts (clouding of the eye lens) or increased eye pressure, which could lead to glaucoma. This trial is in an early phase, so researchers are focusing on understanding the safety and effects of Yutiq in a small group of patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for glaucoma, which often involve topical eye drops or systemic medications, Yutiq is a sustained-release steroid insert. It's implanted along with a glaucoma drainage device during surgery. This delivery method allows for a continuous, localized release of medication directly to the affected area, potentially reducing the need for frequent eye drops. Researchers are excited about this approach because it could improve medication adherence and provide more consistent intraocular pressure control, a crucial factor in managing glaucoma effectively.

What evidence suggests that the Yutiq steroid insert is effective for reducing post-operative scarring in glaucoma patients?

Research has shown that the Yutiq steroid insert effectively reduces eye inflammation and scarring. In studies on uveitis, a condition that causes eye inflammation, Yutiq significantly lowered the chances of inflammation returning compared to a group that didn't receive treatment. Specifically, after 6 months, only 28% of patients using Yutiq experienced a return of inflammation, compared to 91% in the untreated group. Additionally, Yutiq has improved vision, with more patients experiencing better eyesight. In this trial, participants will receive the Yutiq insert alongside a glaucoma drainage device during surgery. These findings suggest that Yutiq may also help manage intraocular pressure and reduce scarring after glaucoma surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Sanjay Asrani, MD

Principal Investigator

Duke Eye Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with glaucoma, except those with inflammation-related types like uveitis. It's for patients planning to have glaucoma tube implant surgery or combined cataract and glaucoma surgery. Participants must not be pregnant, willing to follow the study plan, and able to give informed consent.

Inclusion Criteria

I have been diagnosed with glaucoma, but it's not caused by inflammation or neovascular issues.

Subjects who are willing and able to comply with scheduled visits, treatment plan and other study procedures and are able to provide an informed consent document signed and dated by the subject

Negative urine pregnancy test at baseline for women of childbearing potential

Exclusion Criteria

Patients who are unlikely to comply with the study protocol

I have or might have an eye infection, including herpes or fungal infections.

I have used or might need drugs that weaken my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Implantation

Participants undergo glaucoma tube implant surgery with Yutiq steroid insert

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for safety and efficacy, focusing on intraocular pressure and scarring

36 months

Regular follow-up visits at week 12, month 6, month 12, month 18, month 24, month 30, and month 36

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Yutiq

Trial Overview The study tests if a Yutiq steroid insert can safely control eye pressure and reduce scarring when implanted during glaucoma tube implant surgery. The goal is to see if there's a significant difference in eye pressure after 12 weeks compared to surgeries without Yutiq.

How Is the Trial Designed?

Group I: Yutiq Experimental Treatment 1 Intervention

A sustained-release steroid insert (Yutiq) will be implanted along with a glaucoma drainage device (Ahmed Glaucoma Valve (AGV) Model FP7) when the patient is undergoing glaucoma tube implant surgery or combined glaucoma tube implant and cataract surgery.

Group II: Control Active Control 1 Intervention

Non-study eye will not receive the Yutiq insert

Who Is Running the Clinical Trial?

Sanjay Asrani

Lead Sponsor

Trials

1

Recruited

5+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04918121

A Study of Yutiq Steroid Insert During Glaucoma Tube ... This study proposes that a sustained release steroid insert (Yutiq)1 be implanted along with a glaucoma drainage device (Ahmed Glaucoma Valve (AGV) Model FP7) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6880290/

Preliminary evaluation of YUTIQ™ (fluocinolone acetonide ... The 6-month (28 and 91%) and 12-month (38 and 98%) uveitis recurrence rates were significantly lower (p < 0.001) with fluocinolone acetonide insert versus sham, ...

3. investors.eyepointpharma.com investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-pharmaceuticals-presents-positive-data-showcasing

EyePoint Pharmaceuticals Presents Positive Data ... Results at the 36-month follow up of the Phase 3 trial of YUTIQ demonstrated that visual acuity gains of 3-lines or more were more common with YUTIQ (33.3 ...

4. withpower.com withpower.com/trial/early-phase-1-glaucoma-6-2021-33ac4

Yutiq Steroid Insert for Glaucoma · Info for Participants Trial Overview The study tests if a Yutiq steroid insert can safely control eye pressure and reduce scarring when implanted during glaucoma tube implant surgery ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2451993625000271

Management of ocular hypertension following intravitreal ... Several studies have identified increased IOP as an adverse effect of Ozurdex, often lasting for months due to its sustained release of steroids.4, 5, 6, 7, 8 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39805140/

INTRAVITREAL SUSTAINED RELEASE STEROID ... Conclusion: Intravitreal steroid implants were safe and effective for the treatment of postsurgical CME in patients with pre-existing glaucoma ...

7. researchgate.net researchgate.net/publication/387972612_Intravitreal_Sustained_Release_Steroid_Implants_Are_Safe_and_Effective_in_Patients_With_Glaucoma_Drainage_Devices

Intravitreal Sustained Release Steroid Implants Are Safe ... Outcomes included IOP, IOP rise, central foveal thickness (CFT), and IOP medications. Results We included 14 eyes (14 patients, 38% male, 94% pseudophakic).

8. hcp.yutiq.com hcp.yutiq.com/clinical-studies-data/

Clinical Studies & Data Steroid-related Effects: Use of corticosteroids including YUTIQ may produce posterior subcapsular cataracts, increased intraocular pressure and glaucoma.