CTRI/2014/07/004726已完成3 期
A Phase III, Multinational, Multiceneter, Randomized, Masked, Controlled, Safety and Efficacy study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects with Chronic Non-Infectious Uveitis affecting the Posterior Segment of the Eye
pSivida Corp6 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年8月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Recurrence of uveitis in study eye [ Time Frame: one year ]
研究概览
简要总结
This is a phase 3, multi-national, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. Patients will be randomized to receive either a sham injection or the FAI insert and will be observed for three years following treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Male or non-pregnant female at least 18 years of age at time of consent • One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis > 1 year duration • During the 12 months prior to enrollment (Day1), the study eye has either received treatment: • systemic corticosteroid or other systemic therapies given for at least 3 months, and/or • at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis OR the study eye has experienced recurrence: • at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid • At the time of enrollment (Day 1), study eye has < 10 anterior chamber cells/HPF and a vitreous haze ≤ grade
- •â€¢ Visual acuity of study eye is at least 15 letters on the ETDRS chart • Subject is not planning to undergo elective ocular surgery during the study • Subject has ability to understand and sign the Informed Consent Form • Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures Age eligible fo the study: 18 years & older.
排除标准
- •â€¢ Allergy to fluocinolone acetonide or any component of the FAI insert • History of posterior uveitis only that is not accompanied by vitritis or macular edema • History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze • Uveitis with infectious etiology • Vitreous hemorrhage • Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma) • Ocular malignancy in either eye, including choroidal melanoma • Toxoplasmosis scar in study eye or scar related to previous viral retinitis • Previous viral retinitis • Media opacity precluding evaluation of retina and vitreous • Peripheral retinal detachment in area of insertion • Current diagnosis of any form of glaucoma • Intraocular pressure (IOP) > 21 mmHg or concurrent therapy at Screening with any IOP-lowering agent in the study eye • Chronic hypotony (< 6 mmHg) • Ocular surgery on the study eye within 3 months prior to study Day 1 • Capsulotomy in study eye within 30 days prior to study Day 1 • Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1 • Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1 • Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1 • Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1 • Subjects requiring chronic systemic or inhaled corticosteroid therapy (>15mg prednisone daily) or systemic immunosuppressive therapy to manage non-ocular disease • Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1 • Subjects who have tested positive for human immune deficiency virus (HIV) • Systemic infection within 30 days prior to study Day 1 • 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 entry into this study • Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study • Treatment with an investigational drug or device within 30 days prior to study Day 1 • Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit • Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years.
结局指标
主要结局
Recurrence of uveitis in study eye [ Time Frame: one year ]
时间窗: Time Frame: one year
[ Designated as safety issue: No ]
时间窗: Time Frame: one year
次要结局
- Recurrence of uveitis in the study eye [ Time Frame: three years ]([ Designated as safety issue: No ])
研究者
研究点 (6)
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