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Clinical Trials in China / NCT05592717
Recruiting Observational

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

NCT05592717 · tracked via the Priya Life Science China tracker
Sponsor
Tianjin Medical University
Phase
Observational
Started
2023-01-05
Last updated
2024-07-03

Condition(s) studied

UveitisYUTIQ

Investigational drug(s) / intervention(s)

Yutiq

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female in good general health at 18 to 70 years of age. 2. Presence of unilateral or bilateral non-infectious uveitis affecting the posterior segment 3. 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. 4. Steroids and immunosuppressive agents were discontinued within 3 months after Yutiq injection. Exclusion Criteria: 1. Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial. 2. Subject with a history of neurologic symptoms suggestive of central nervous system demyelinating disease. 3. Prior intravitreal treatment with Retisert®, ILUVIEN®, or YUTIQ® (0.18 mg) within 36 months prior to Day 1. 4. 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. 5. Peri-ocular or subtenon steroid treatment within 12 weeks prior to Day 1. 6. Media opacity precluding evaluation of retina and vitreous (eg, vitreous hemorrhage). 7. Hypersensitivity to any of the ingredients contained in YUTIQ®. 8. Any other systemic or ocular condition which, in the judgment of the Investigator, could make the subject inappropriate for study enrollment. 9. 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University Eye Hospital Tianjin Tianjin Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05592717 on ClinicalTrials.gov ↗ ← All trials in China