What is YUTIQ studying for chronic non-infectious uveitis?

YUTIQ is being studied to evaluate its effects in managing chronic non-infectious uveitis. Researchers aim to understand how well this 0.18 mg intravitreal implant reduces inflammation and relapse rates compared to traditional treatments. The study is sponsored by Tianjin Medical University to improve treatment options for this eye condition.

Who may be eligible for this uveitis clinical trial?

Adults aged 18 to 70 years with unilateral or bilateral non-infectious uveitis affecting the back of the eye may be eligible. Participants should have active inflammation signs and be generally healthy. Both men and women can join, but pregnant or nursing women and those unwilling to use contraception are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this uveitis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary depending on individual circumstances and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Age: 18Years - 70Years

All Genders

ID05592717

Observational Study of YUTIQ 0.18 mg Implant for Treating Chronic Non-infectious Uveitis in Adults Aged 18 to 70

Led by Tianjin Medical University · Updated on 2024-07-03

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of YUTIQ4 0.18 mg intravitreal implant for managing chronic non-infectious uveitis. This observational study divides participants into two groups one receiving the YUTIQ implant and the other receiving traditional therapy with glucocorticoids alone or combined with immunosuppressants. The study aims to assess anti-inflammatory effects and relapse reduction over time. Participants in the YUTIQ group receive a 0.18 mg implant injected into the designated study eye and are followed for up to 36 months. The traditional therapy group receives glucocorticoids or glucocorticoids plus immunosuppressants and is also monitored for up to 36 months. The study compares outcomes between these two groups throughout the follow-up period. Participants will undergo assessments including best corrected visual acuity BCVA, anterior chamber and vitreous inflammation, optical coherence tomography OCT, and corticosteroid dose changes. Researchers will track these outcomes at regular visits over 12 to 36 months to evaluate changes in vision, inflammation, and recurrence rates. Safety and side effects will also be monitored during the study period.

CONDITIONS

Brief Title

A Study of YUTIQ® 0.18 mg Intravitreal Implant for the Management of Chronic Non-infectious Uveitis

Who Can Participate

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Male or female aged 18 to 70 years in good general health
Unilateral or bilateral non-infectious uveitis affecting the posterior segment
Active inflammation before YUTIQ treatment meeting at least one: 1+ anterior chamber cell, 1+ vitreous haze, fluorescein angiography leakages, macular edema on OCT, or 3 relapses in one year
Steroids and immunosuppressive agents discontinued within 3 months after YUTIQ injection

You will not qualify if you...

Corneal or lens opacity preventing fundus visualization or likely requiring cataract surgery during the trial
History of neurologic symptoms suggesting central nervous system demyelinating disease
Prior intravitreal treatment with Retisert, ILUVIEN, or YUTIQ within 36 months before Day 1
Prior intravitreal treatment with OZURDEX, Triesence, or TRIVARIS within 12 weeks before Day 1
Peri-ocular or subtenon steroid treatment within 12 weeks before Day 1
Media opacity preventing retina and vitreous evaluation (e.g., vitreous hemorrhage)
Hypersensitivity to any ingredients in YUTIQ
Any other systemic or ocular condition making the subject unsuitable for enrollment
Pregnant or nursing females; females of childbearing potential unwilling or unable to use acceptable contraception from 14 days before Day 1 until final visit

Research Team

xiaomin Zhang

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