Uveitis Clinical Trial
Official title:
An Observational Study of YUTIQ (Fluocinolone Acetonide Intravitreal Implant 0.18 mg) for the Management of Chronic Non-infectious Uveitis
NCT number | NCT05592717 |
Other study ID # | 2022KY-17 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 5, 2023 |
Est. completion date | November 1, 2026 |
This project is designed to evaluate the efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious uveitis.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | November 1, 2026 |
Est. primary completion date | November 1, 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Tianjin Medical University Eye Hospital | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit. | Participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment. | 12 months | |
Primary | Recurrence rates | The recurrence rates in Yutiq group and traditional therapy group | 36 months | |
Secondary | Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit | Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:
Grade 0 = < 1 cell Grade 0.5+ = 1 - 5 cells Grade 1+ = 6 - 15 cells Grade 2+ = 16 - 25 cells Grade 3+ = 26 - 50 cells Grade 4+ = > 50 cells. |
12 months | |
Secondary | Prednisone exposure | Cumulative prednisone dose and/or mean prednisone dose | 36 months |
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