What side effects are associated with this type of intervention?

Common treatments for glaucoma include medications, laser therapy, and surgical interventions. Medications such as prostaglandin analogs, beta-blockers, and carbonic anhydrase inhibitors can cause side effects like eye redness, stinging, blurred vision, and systemic effects such as fatigue or changes in heart rate. Laser therapies, like trabeculoplasty, may lead to temporary eye inflammation or increased intraocular pressure. Surgical options, including glaucoma drainage devices like the Ahmed Glaucoma Valve, can result in complications such as infection, bleeding, or scarring. Specifically, the use of sustained-release steroid inserts like Yutiq aims to reduce post-operative scarring and control intraocular pressure but may carry risks of cataracts, elevated intraocular pressure, and potential for infection.

What prior FDA approvals exist?

The FDA has approved several treatments for glaucoma that focus on reducing intraocular pressure (IOP) and minimizing post-operative scarring. Notably, sustained-release drug delivery systems like the Yutiq insert are designed to provide long-term medication release, improving patient compliance and outcomes. Similar treatments include the use of sustained-release formulations of prostaglandin analogs, such as bimatoprost, which have been approved for enhancing eyelash growth and potentially reducing IOP. Additionally, 5-fluorouracil (5-FU) has been studied in combination with glaucoma drainage devices to inhibit post-operative scarring. These treatments highlight the ongoing efforts to improve glaucoma management through innovative drug delivery systems.

What other types of research exist?

Promising alternatives to Yutiq for glaucoma patients include 5-fluorouracil (5-Fu)-polycaprolactone sustained-release film, mitomycin C-coated glaucoma drainage devices, and GGRGDSPCA peptide. These treatments have shown efficacy in reducing post-operative scarring and inflammation, which can help control intraocular pressure.

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Yutiq Steroid Insert for Glaucoma

Q: What is the mechanism of action of this treatment?

Common treatments for glaucoma primarily aim to reduce intraocular pressure (IOP) to prevent optic nerve damage. Medications like prostaglandin analogs increase the outflow of aqueous humor, while beta-blockers reduce its production. Sustained-release steroid inserts, such as Yutiq, are being studied for their potential to reduce post-operative scarring and control IOP by providing a steady release of anti-inflammatory medication. This is crucial for glaucoma patients as it may enhance surgical outcomes and maintain lower IOP levels over time, reducing the risk of vision loss.

Phase < 1

Waitlist Available

Led By Sanjay Asrani, MD

Research Sponsored by Sanjay Asrani

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years old at time of consent

Patient being consented for either glaucoma tube implant surgery in pseudophakic eyes or being consented for cataract surgery with glaucoma tube implant surgery

Must not have

Patients with active or suspected ocular or periocular infections including most viral diseases such as herpes simplex, vaccinia, varicella, mycobacterial infections and fungal diseases

Allergy to corticosteroids or any component of Yutiq insert

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12, month 6, month 12, month 18, month 24, month 30 , month 36

Awards & highlights

Approved for 5 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of the Yutiq insert may include increased risk of infection, possible allergic reactions, and complications related to steroid use such as elevated eye pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for glaucoma tube implant surgery, with or without cataract surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am allergic to corticosteroids or components of Yutiq insert.

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I am receiving anti-VEGF therapy in my affected eye.

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I am not pregnant or breastfeeding and willing to use birth control during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12, month 6, month 12, month 18, month 24, month 30 , month 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12, month 6, month 12, month 18, month 24, month 30 , month 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12, month 6, month 12, month 18, month 24, month 30 , month 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in IOP measured using Goldman applanation tonometry

Change in IOP measured using tonopen/Icare

Days on Steroid therapy by medical record abstraction

+2 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: YutiqExperimental Treatment1 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: ControlActive Control1 Intervention

Non-study eye will not receive the Yutiq insert

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for glaucoma primarily aim to reduce intraocular pressure (IOP) to prevent optic nerve damage. Medications like prostaglandin analogs increase the outflow of aqueous humor, while beta-blockers reduce its production. Sustained-release steroid inserts, such as Yutiq, are being studied for their potential to reduce post-operative scarring and control IOP by providing a steady release of anti-inflammatory medication. This is crucial for glaucoma patients as it may enhance surgical outcomes and maintain lower IOP levels over time, reducing the risk of vision loss.

The effects of topical mitomycin on glaucoma filtration surgery in rabbits.Hybrid dendrimer hydrogel/poly(lactic-co-glycolic acid) nanoparticle platform: an advanced vehicle for topical delivery of antiglaucoma drugs and a likely solution to improving compliance and adherence in glaucoma management.Cationic nano-copolymers mediated IKKβ targeting siRNA to modulate wound healing in a monkey model of glaucoma filtration surgery.