Actively Recruiting
An Observational Study of YUTIQ (Fluocinolone Acetonide Intravitreal Implant 0.18 mg) for the Management of Chronic Non-infectious Uveitis
Led by Tianjin Medical University · Updated on 2024-07-03
15
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants in the Yutiq group receive the YUTIQ® 0.18 mg intravitreal implant in the designated study eye. Participants in the traditional therapy group continue treatment with glucocorticoids alone or combined with immunosuppressants.
Visits to assess vision and inflammation at multiple timepoints during treatment
Duration - Up to 36 months
Participants are followed to assess changes in visual acuity, inflammation, recurrence rates, and corticosteroid exposure over the study period.
Regular visits throughout the follow-up period for assessments
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
X
xiaomin Zhang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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