An Observational Study of YUTIQ (Fluocinolone Acetonide Intravitreal Implant 0.18 mg) for the Management of Chronic Non-infectious Uveitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.
研究概览
简要总结
This project is designed to evaluate the efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious uveitis.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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+ anterior chamber cell and/or ≥1+ vitreous haze.
- •Fluorescein angiography demonstrates leakages.
- •OCT images showing the macular edema.
- •The times of relapse in one year are equal to or greater than
- •Steroids and immunosuppressive agents were discontinued within 3 months after Yutiq injection.
排除标准
- •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
- •Prior intravitreal treatment with OZURDEX® within 12 weeks prior to Day
- •Prior intravitreal treatment with Triesence® or TRIVARIS™ (triamcinolone) within 12 weeks prior to Day
- •Peri-ocular or subtenon steroid treatment within 12 weeks prior to Day
- •Media opacity precluding evaluation of retina and vitreous (eg, vitreous hemorrhage).
- •Hypersensitivity to any of the ingredients contained in YUTIQ®.
- •Any other systemic or ocular condition which, in the judgment of the Investigator, could make the subject inappropriate for study enrollment.
- •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.
研究组 & 干预措施
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.
干预措施: Yutiq (Drug)
结局指标
主要结局
Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.
时间窗: 12 months
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
时间窗: 36 months
The recurrence rates in Yutiq group and traditional therapy group
次要结局
- Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit(12 months)
- Prednisone exposure(36 months)
研究者
Xiaomin Zhang
Principal Investigator, MD, PhD
Tianjin Medical University