A Study of YUTIQ® 0.18 mg Intravitreal Implant for the Management of Chronic Non-infectious Uveitis
NCT ID: NCT05592717
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
15 participants
OBSERVATIONAL
2023-01-05
2026-11-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Yutiq group
Patients will receive YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye and will be followed for 36 months after treatment.
Yutiq
YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye.
traditional therapy group
Patients were treated with glucocorticoids alone or glucocorticoids combined with immunosuppressants and were followed for up to 36 months.
No interventions assigned to this group
Interventions
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Yutiq
YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Tianjin Medical University
OTHER
Responsible Party
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Xiaomin Zhang
Principal Investigator, MD, PhD
Locations
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Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022KY-17
Identifier Type: -
Identifier Source: org_study_id
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