RecruitingNCT05592717

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

An Observational Study of YUTIQ (Fluocinolone Acetonide Intravitreal Implant 0.18 mg) for the Management of Chronic Non-infectious Uveitis

Sponsor

Tianjin Medical University

Enrollment

15 participants

Start Date

Jan 5, 2023

Study Type

OBSERVATIONAL

Conditions

This project is designed to evaluate the efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious uveitis.

Min Age: 18 YearsMax Age: 70 Years

Male or female in good general health at 18 to 70 years of age.
Presence of unilateral or bilateral non-infectious uveitis affecting the posterior segment
Patients have active inflammation before Yutiq treatment. Subject meets at least 1 of the following criteria: 1. ≥1+ anterior chamber cell and/or ≥1+ vitreous haze. 2. Fluorescein angiography demonstrates leakages. 3. OCT images showing the macular edema. 4. The times of relapse in one year are equal to or greater than 3.
Steroids and immunosuppressive agents were discontinued within 3 months after Yutiq injection.

Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
Subject with a history of neurologic symptoms suggestive of central nervous system demyelinating disease.
Prior intravitreal treatment with Retisert®, ILUVIEN®, or YUTIQ® (0.18 mg) within 36 months prior to Day 1.
Prior intravitreal treatment with OZURDEX® within 12 weeks prior to Day 1. Prior intravitreal treatment with Triesence® or TRIVARIS™ (triamcinolone) within 12 weeks prior to Day 1.
Peri-ocular or subtenon steroid treatment within 12 weeks prior to Day 1.
Media opacity precluding evaluation of retina and vitreous (eg, vitreous hemorrhage).
Hypersensitivity to any of the ingredients contained in YUTIQ®.
Any other systemic or ocular condition which, in the judgment of the Investigator, could make the subject inappropriate for study enrollment.
Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to Day 1 until the final study visit.

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DRUGYutiq

YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye.

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05592717