About this trial
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
This trial does not accept healthy volunteersQualifiers
Male or female in good general health at 18 to 70 years of age.
Presence of unilateral or bilateral non-infectious uveitis affecting the posterior segment
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.
Steroids and immunosuppressive agents were discontinued within 3 months after Yutiq injection.
Disqualifiers
Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
Subject with a history of neurologic symptoms suggestive of central nervous system demyelinating disease.
Prior intravitreal treatment with Retisert®, ILUVIEN®, or YUTIQ® (0.18 mg) within 36 months prior to Day 1.
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.
Trial population
Chronic non-infectious uveitis patients were recruited from the uveitis centre of Tianjin Medical University Eye Hospital
Trial design
Cohort
Prospective
Treatments tested in this trial
Yutiq
DrugYUTIQ® 0.18 mg as an intravitreal injection in the designated study eye.
Treatment groups
Trial outcomes
Primary outcomes
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.
Recurrence rates
The recurrence rates in Yutiq group and traditional therapy group
Secondary outcomes
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.
Prednisone exposure
Cumulative prednisone dose and/or mean prednisone dose
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