NCT05070728终止3 期
A Phase 3, Multicenter, Prospective, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide (FA) Intravitreal 0.05 mg Insert (Yutiq 0.05 mg) in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 24
研究概览
简要总结
A study to evaluate the safety and efficacy of a fluocinolone acetonide intravitreal (FAI) insert in the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye.
详细描述
This was a phase 3, multicenter, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable FAI insert for the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye. Subjects were randomized to receive either a sham injection or the FAI insert and were observed for 1 year following treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female at least 18 years of age at time of consent.
- •One or both eyes had a history of recurrent non-infectious uveitis affecting the posterior segment of the eye (intermediate, posterior, or panuveitis) with or without anterior uveitis >1 year duration.
- •During the 52 weeks prior to enrollment (Day 1), the subject must have received treatment for uveitis in the study eye with:
- •Systemic corticosteroid or other systemic therapies for at least 12 consecutive or non-consecutive weeks, AND/OR
- •at least 2 intra- or peri-ocular administrations of corticosteroid in the study eye, OR
- •the study eye has experienced recurrence of uveitis at least 2 separate times requiring systemic, intra- or peri-ocular injection of corticosteroid.
- •At the time of enrollment (Day 1), the study eye has <10 anterior chamber cells/HPF (high power field) and a vitreous haze ≤ grade
- •Visual acuity of study eye ≥15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
- •Not planning to undergo elective ocular surgery during the study.
- •Able to understand and sign the Informed Consent Form (ICF).
- •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •Ocular Exclusion Criteria (for the study eye, unless indicated otherwise):
- •History of posterior uveitis only that is not accompanied by vitritis or macular edema.
- •History of iritis only associated with no vitreous cells, anterior chamber cells, or vitreous haze at Day
- •Uveitis with infectious etiology.
- •Vitreous hemorrhage.
- •Intraocular inflammation associated with a condition other than noninfectious uveitis (eg, intraocular lymphoma).
- •Uveitis limited to the anterior segment, ie, anterior uveitis only.
- •Ocular malignancy in either eye, including choroidal melanoma.
- •Previous viral retinitis.
- •Toxoplasmosis scar or scar related to previous viral retinitis in the study eye.
- •Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye, or fungal diseases of ocular structures.
- •Media opacity precluding evaluation of retina and vitreous.
- •Peripheral retinal detachment in area of insertion.
- •Diagnosis of any form of glaucoma or ocular hypertension at Screening, unless previously treated with an incisional surgery procedure that has resulted in stable intraocular pressure (IOP) in the normal range [10-21 millimeter of mercury (mmHg)].
- •IOP >21 mmHg or concurrent therapy at Screening with any IOP lowering pharmacologic agent.
- •Chronic hypotony (<6 mmHg).
- •Ocular surgery within 12 weeks prior to Day
- •Capsulotomy within 30 days prior to Day
- •Prior intravitreal treatment with Retisert®, ILUVIEN®, or YUTIQ® (0.18 mg) within 156 weeks prior to Day
- •Prior intravitreal treatment with OZURDEX® or sub-choroidal injection with XIPERE™ within 24 weeks prior to Day
- •Prior intravitreal treatment with Triesence® or TRIVARIS™ within 12 weeks prior to Day
- •Peri-ocular or subtenon steroid treatment within 12 weeks prior to Day
- •All other Exclusion Criteria:
- •Allergy to fluocinolone acetonide or any component of Yutiq 0.05 mg.
- •Requirement for chronic systemic or inhaled corticosteroid therapy (>15mg prednisone daily) or chronic systemic immunosuppressive therapy.
- •History of certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to Day
- •Positive test for human immunodeficiency virus (HIV) or syphilis during Screening.
- •Mycobacterial uveitis or chorioretinal changes of either eye which, in the opinion of the Investigator, result from infectious mycobacterial uveitis.
- •Systemic infection within 30 days prior to Day
- •Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the Investigator, could make the subject inappropriate for study enrollment.
- •Any other systemic or ocular condition which, in the judgment of the Investigator, could make the subject inappropriate for study enrollment.
- •Treatment with an investigational drug or device within 30 days prior to Day
- •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 52-week Visit.
- •Unlikely to comply with the study protocol or who are likely to be lost to follow-up within 52 weeks.
研究组 & 干预措施
Sham Comparator
Sham Comparator
Intravitreal sham injection
干预措施: Sham Injector (Drug)
FAI insert (0.05 mg fluocinolone acetonide)
Active Comparator
Fluocinolone acetonide (FA) intravitreal 0.05 mg insert (Yutiq 0.05 mg).
干预措施: FAI Insert (Drug)
结局指标
主要结局
Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 24
时间窗: Week 24
Recurrence was defined as: * An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit; or * A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit.
次要结局
- Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 52(Week 52)
- Percentage of Subjects With Recurrence of Uveitis in the Fellow Eye at Weeks 24 and 52(Weeks 24 and 52)
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Weeks 24 and 52(Weeks 24 and 52)
- Number of Recurrences of Uveitis Within 24 and 52 Weeks(Weeks 24 and 52)
- Time to Recurrence of Uveitis Through Weeks 24 and 52(Weeks 24 and 52)
- Number of Adjunctive Treatments Required to Treat Recurrences of Uveitis at 24 and 52 Weeks(Weeks 24 and 52)
- Percentage of Subjects With Recurrence of Iridocyclitis in the Study Eye Compared to Baseline at 24 and 52 Weeks(Weeks 24 and 52)
- Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12(At Day 28 and Months 2, 3, 6 and 12)
研究者
研究点 (1)
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