Status:

RECRUITING

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

Lead Sponsor:

Tianjin Medical University

Conditions:

Uveitis

YUTIQ

Eligibility:

All Genders

18-70 years

Brief Summary

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

Detailed Description

Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written infor...

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.

Key Trial Info

Start Date :

January 5 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

November 1 2026

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT05592717

Start Date

January 5 2023

End Date

November 1 2026

Last Update

July 3 2024

Active Locations (1)

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Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China, 300000