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

Last updated: July 1, 2024
Sponsor: Tianjin Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Uveitis

Treatment

Yutiq

Clinical Study ID

NCT05592717
2022KY-17
  • Ages 18-70
  • All Genders

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 Criteria

Inclusion

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 posteriorsegment

  3. Patients have active inflammation before Yutiq treatment. Subject meets at least 1of the following criteria: 1. ≥1+ anterior chamber cell and/or ≥1+ vitreous haze. 2.Fluorescein angiography demonstrates leakages. 3. OCT images showing the macularedema. 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 Yutiqinjection.

Exclusion

Exclusion Criteria:

  1. Subject with corneal or lens opacity that precludes visualization of the fundus orthat likely requires cataract surgery during the duration of the trial.

  2. Subject with a history of neurologic symptoms suggestive of central nervous systemdemyelinating disease.

  3. Prior intravitreal treatment with Retisert®, ILUVIEN®, or YUTIQ® (0.18 mg) within 36months prior to Day 1.

  4. Prior intravitreal treatment with OZURDEX® within 12 weeks prior to Day 1. Priorintravitreal treatment with Triesence® or TRIVARIS™ (triamcinolone) within 12 weeksprior 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, vitreoushemorrhage).

  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 orunable to use an acceptable method of contraception as outlined in the protocol fromat least 14 days prior to Day 1 until the final study visit.

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Yutiq
Phase:
Study Start date:
January 05, 2023
Estimated Completion Date:
November 01, 2026

Study 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 informed consent and received a thorough explanation of the use of Yutiq, its potential risks and benefits. This is a monocenter, cohort, observational study evaluating patients with chronic non-infectious uveitis divided into two groups: Yutiq therapy group and traditional therapy group.

For Yutiq therapy group, patients will receive YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye. For the traditional therapy group, patients were treated with glucocorticoids alone or glucocorticoids combined with immunosuppressants. Study participants will be followed for up to 3 years to determine efficacy and side effects.

According to best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, optical coherence tomography (OCT), change in corticosteroid dose during the study period and so on. The investigators evaluate the anti-inflammatory and reducing relapses effects of Yutiq in treatment of chronic non-infectious uveitis.

Connect with a study center

  • Tianjin Medical University Eye Hospital

    Tianjin, Tianjin 300000
    China

    Active - Recruiting

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