使用两种 YUTIQ 与假手术治疗影响后节的慢性非感染性眼内炎症 (TYNI)
使用两种 YUTIQ 与假手术治疗影响后节的慢性非感染性眼内炎症(TYNI 试验)
The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)
研究概览
详细说明
1.0 RATIONALE AND NEEDS ASSESSMENT Primary Eyepoint Drug(s): YUTIQ
Study Rationale:
The current data shows that in eyes from patients with chronic non-infectious posterior uveitis(NIPU), a single YUTIQ implant decreases the number of uveitis recurrences, led to less necessary adjunctive treatments, demonstrated less visual acuity loss, and had an acceptable side effect profile. Naturally, we asked whether two YUTIQ implants at the time of treatment would lead to an improved level of control of intraocular inflammation. We propose to evaluate the safety and efficacy of two YUTIQ implants versus two sham injections to manage inflammation associated with NIPU.
Needs Assessment:
Chronic noninfectious uveitis of the posterior segment of the eye is a visually debilitating disease to patients affected with it. Untreated or undertreated recurrent episodes of inflammation in these patients lead to permanent damage to the intraocular structures of the eye resulting in irreversible vision loss. Recent data has shown that a single YUTIQ implant demonstrated an improved level of control of intraocular inflammation, decreased frequency of uveitis flare ups, and led to less visual acuity loss compared to sham. However, there were still patients in the treatment group who had suboptimal control of their intraocular inflammation, experienced uveitis flares, and had a decrease in best-corrected visual acuity (BCVA). A study evaluating two YUTIQ implants for chronic NIPU would provide data to address whether this treatment paradigm would lead to superior outcomes and reduced treatment burden. There are currently no published prospective trials that have evaluated primary therapy with two YUTIQ implants.
In this study, we aim to compare the recurrence rate of uveitis by month 6 of two YUTIQ intravitreal implants to sha m. The clinical definition of intraocular inflammation recurrence is ( a 2 step or more increase in number of cells in the anterior chamber per high powered field (x1.6 using a 1 mm beam), ( a 2 step or more increase in vitreous haze, or ( a deterioration in BCVA of 15 letters or more. We expect a decreased rate of uveitis recurrences compared to sham. We also expect a decrease in inflammatory recurrences and increased time to first recurrence compared to prior data evaluating the use of a single YUTI Q implant.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
-
-
Texas
-
Plano、Texas、美国、75075
- Texas Retina Associates
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
General Inclusion Criteria:
- Male or non-pregnant female in good general health at least 18 years of age, understands the language of the informed consent, and is willing and able to provide written informed consent and sign/date a health information release (HIPAA form) before any study procedures are performed.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Ocular Inclusion Criteria (Study Eye):
- Diagnosed with chronic unilateral or bilateral noninfectious posterior segment inflammation (with or without anterior uveitis) that demonstrated a clinical response to ≥1 previous corticosteroid treatment of any localized type (eg, topical steroid 2 to 4 times per day or intra- or peri-ocular injection) or systemic corticosteroid/immunosuppressant treatment with recurrence following treatment indicating chronicity according to the Investigator's judgment.
- Presence of active posterior segment inflammation as determined by the Investigator.
- Vitreous haze grade ≥ 2 based on the standardization of uveitis nomenclature (SUN) criteria.
- Less than 10 anterior chamber cells/high power field determined by slit lamp examination.
- Not planning to undergo elective ocular surgery during the study.
Exclusion Criteria:
General Exclusion Criteria:
- Subjects with known hypersensitivity to any components of YUTIQ.
- Female subjects who are pregnant or breastfeeding.
- Has any acute or chronic medical disease or psychiatric condition that, in the opinion of the Investigator, would preclude participation in the study or put the subject at risk due to study treatment or procedures.
Ocular Exclusion Criteria (Study Eye):
- History of anterior uveitis only (without associated uveitis that affected the posterior segment).
- Presence of a vitreous hemorrhage.
- Uveitis with infectious etiology.
- Intraocular inflammation associated with a condition other than non-infectious uveitis (e.g., intraocular lymphoma).
- Current infectious diseases of the cornea and conjunctiva, mycobacterial infections of the eye, or fungal diseases of ocular structures.
- Subjects with ACIOL (Anterior Chamber Intraocular Lens) or rupture of the posterior lens capsule.
- Diagnosis of any form of glaucoma or ocular hypertension at screening, unless the study eye is being treated with ≤2 intraocular pressure (IOP)-lowering medications and/or has been previously treated with an incisional surgical procedure resulting in stable IOP in the normal range (10 to 21 mmHg).
- Intraocular pressure >21 mmHg or concurrent therapy at screening with >2 IOP-lowering pharmacologic agents in the study eye.
- Any eye surgery within 12 weeks prior to Day 1 of the study.
- Subjects who are unable to attend scheduled follow-up visits throughout the 12-month study.
- Has a significant media opacity precluding evaluation of retina and vitreous in the study eye.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Treatment Arm
This group will receive two YUTIQ implants at day 1. |
YUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg, for intravitreal injection |
|
假比较器:Control Arm
This group will receive two sham injections at day 1. |
Sham injection |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recurrence rate of uveitis will be assessed at the 6-month visit
大体时间:6 months
|
The primary endpoint of recurrence rate of uveitis will be assessed at the 6-month visit. The clinical definition of intraocular inflammation recurrence is (1) a 2-step or more increase in number of cells in the anterior chamber per high-powered field (x1.6 using a 1-mm beam), (2) a 2-step or more increase in vitreous haze, or (3) a deterioration in BCVA of 15 letters or more. In each case, the etiology of the change must be only due to noninfectious uveitis. |
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recurrence rate of uveitis at the 12-month visit
大体时间:12 months
|
The secondary endpoints include determining the recurrence rate of uveitis at the 12-month visit, time to first uveitis recurrence, change in BCVA from baseline by ETDRS letters read at the 12-month visit, total number of necessary adjunctive treatments necessary, mean changes in CST as measured by SD-OCT, and mean changes from baseline in BCVA by ETDRS letters read. A final secondary endpoint will be to evaluate the changes in vascular leakage on FA, which will qualitatively be determined by the investigator. |
12 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.