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

5 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a small device that releases a steroid into the eye during glaucoma surgery to reduce scarring and control eye pressure. It targets patients having glaucoma or combined glaucoma and cataract surgery. The steroid helps reduce inflammation, aiming for better post-surgery outcomes.

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 data supports the effectiveness of the drug Yutiq for treating glaucoma?

While there is no direct evidence for Yutiq's effectiveness in treating glaucoma, it is used for uveitis (eye inflammation), and similar steroid implants have been shown to manage eye pressure, which is important in glaucoma treatment. Monitoring and managing eye pressure is crucial when using steroid implants like Yutiq. ^{1 2 3 4 5}

Is the Yutiq steroid insert generally safe for humans?

The Yutiq steroid insert, used for eye conditions like uveitis, has been shown to be generally safe, but it can cause increased eye pressure in some people, which may lead to glaucoma (a condition that can damage the optic nerve). It's important to monitor eye pressure regularly if using this treatment. ^{1 5 6 7 8}

How does the Yutiq steroid insert differ from other glaucoma treatments?

The Yutiq steroid insert is unique because it is a tiny implant placed inside the eye that slowly releases a steroid over a long period, reducing the need for frequent treatments. This approach is different from typical glaucoma treatments, which often involve daily eye drops or surgeries to lower eye pressure. ^{1 3 6 9 10}

Research Team

Sanjay Asrani, MD

Principal Investigator

Duke Eye Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of the Fluocinolone Acetonide (Yutiq) Intravitreal Implant as Monotherapy for Uveitis. [2023]

2. France pubmed.ncbi.nlm.nih.gov

Ocular hypertension and intravitreal steroids injections, update in 2023. French guidelines of the French glaucoma society and the French ophthalmology society. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Combined fluocinolone acetonide intravitreal insertion and glaucoma drainage device placement for chronic uveitis and glaucoma. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Incidence and Outcome of Uveitic Glaucoma in Eyes With Intermediate, Posterior, or Panuveitis Followed up to 10 Years After Randomization to Fluocinolone Acetonide Implant or Systemic Therapy. [2022]

5. France pubmed.ncbi.nlm.nih.gov

[Intraocular pressure elevation and intravitreal steroid implant injection: State of the art in 2023. Recommendations of the French Glaucoma Society and French Ophthalmology Society [French version]]. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of YUTIQ™ (fluocinolone acetonide intravitreal implant 0.18 mg) in posterior uveitis. [2020]

7. Romania pubmed.ncbi.nlm.nih.gov

[Steroid induced ocular hypertension and glaucoma]. [2009]

8. England pubmed.ncbi.nlm.nih.gov

Safety of 6000 intravitreal dexamethasone implants. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

INTRAVITREAL FLUOCINOLONE ACETONIDE IMPLANT FOR RADIATION RETINOPATHY: Report of Preliminary Findings. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Pars plana vitrectomy, fluocinolone acetonide implantation, and silicone oil infusion for the treatment of chronic, refractory uveitic hypotony. [2013]