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Search / Trial NCT05592717

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

Launched by TIANJIN MEDICAL UNIVERSITY · Oct 23, 2022

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special implant called YUTIQ® 0.18 mg to help manage a condition known as chronic non-infectious uveitis, which causes inflammation in the eye. The goal is to see how effective this implant is in reducing inflammation and improving patients' vision. The trial is currently looking for participants aged 18 to 70 who are in good health and have active uveitis, meaning they have signs of inflammation in their eyes.

To be eligible for the study, participants should not have had certain eye treatments or surgeries recently, and they should not have other serious health conditions that could interfere with the study. If you join the trial, you will receive the YUTIQ implant and be monitored regularly by the research team to see how well it works for you. It's important to know that pregnant or nursing women, as well as those who cannot use birth control, are not eligible for this study. This trial aims to find a better way to help people with this eye condition feel better and see more clearly.

Gender

ALL

Eligibility criteria

  • 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.

About Tianjin Medical University

Tianjin Medical University is a prestigious institution dedicated to advancing medical science and healthcare through innovative research and education. As a leading clinical trial sponsor, the university is committed to conducting rigorous and ethically sound clinical studies that aim to enhance patient outcomes and contribute to the global body of medical knowledge. With a focus on collaboration and interdisciplinary approaches, Tianjin Medical University leverages its extensive resources and expertise to support the development of new therapies and improve clinical practices across a wide range of medical disciplines.

Locations

Tianjin, Tianjin, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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