A Non-randomised, Open-label, Uncontrolled, Multi-centre, Phase IIIb Study Evaluating the Safety and Efficacy of Fluocinolone Acetonide 190 Micrograms Intravitreal Implant in Paediatric Subjects From 6 Years to Less Than 18 Years With Recurrent Non-infectious Uveitis Affecting the Posterior Segment of the Eye
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Absence of cystoid macular oedema on Optical Coherence Tomography and a decrease from baseline in vitreous haze grade of ≥2 steps, or absence of vitreous haze.
研究概览
简要总结
The main aim is to test how safe and effective the medicine ILUVIEN® (190μg) is for children and adolescents, who have non-infectious uveitis that keeps coming back and affects the back of the eye.
The main thing Alimera wants to find out is how well the implant works for treating non-infectious uveitis in the back of the eye. Treatment success will be measured after 6 months of using the implant.
The treatment will be considered successful if two things happen:
- No swelling in the back of the eye called cystoid macular oedema;
- A decrease in the cloudiness inside the eye, called vitreous haze, by at least two levels compared to how it was before the treatment, or the vitreous haze is completely gone.
Participants will:
- Receive a single treatment with ILUVIEN®, which is a tiny tube that is to be implanted in the eye and releases low levels of the corticosteroid (fluocinolone acetonide) in the eye for up to 36 months.
- Be followed for 36 months for checkups and tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females of ≥6 and <18 years of age at time of consent
- •Non-infectious posterior, intermediate or panuveitis in the study eye with a history of recurrence ≥1 per year as assessed by the Investigator
- •Uveitis in the study eye not adequately controlled by the preferred standard of care due to intolerable adverse effects or poor response, in the judgment of the Investigator
- •Treatment with systemic corticosteroid or other systemic therapies given for at least 3 months within the previous 12 months prior to Day 1
排除标准
- •History of intraocular surgery in the study eye within 90 days of the screening visit.
- •Hypersensitivity to FA or any component of ILUVIEN®
- •History of any form of glaucoma or ocular hypertension in study eye, unless study eye has been previously treated with an incisional IOP-lowering surgical procedure at least 90 days prior to the screening visit and that procedure has resulted in stable IOP in the normal range (10-21 mmHg)
- •Increased intraocular pressure >25 mmHg or that required treatment including increases in medications, surgery (other than drainage surgery), or hospitalisations, within 4 weeks prior to baseline that, in the opinion of the Investigator, would pose an unacceptable risk to the patient participating in the study
研究组 & 干预措施
ILUVIEN® 190μg
干预措施: fluocinolone acetonide 190 micrograms (Drug)
结局指标
主要结局
Absence of cystoid macular oedema on Optical Coherence Tomography and a decrease from baseline in vitreous haze grade of ≥2 steps, or absence of vitreous haze.
时间窗: 6 months after administration
The primary endpoint for evaluating the effect of the implant on non-infectious uveitis affecting the posterior segment of the eye will be based on treatment success, determined at 6 months after administration. Treatment success will be determined based on a composite variable defined as Absence of cystoid macular oedema on Optical Coherence Tomography and a decrease from baseline in vitreous haze grade of ≥2 steps, or absence of vitreous haze.
Rate of cataract formation and Rate of IOP elevation
时间窗: 6 months after administration
The primary endpoint for evaluating the safety of the implant on non-infectious uveitis affecting the posterior segment of the eye will be determined. * Rate of cataract formation * Rate of IOP elevation (Change from baseline in IOP and incidence of significant changes in IOP, including: IOP\>21 mmHg, IOP\>25 mmHg, IOP\>30 mmHg, increases from baseline of 10 mmHg or more).
次要结局
- Changes in vision and incidence of increase in IOP, AE, and uveitis recurrence(Every 6 months over 3 years)
- Incidence of secondary increase in IOP, secondary increase in IOP requiring surgical intervention, and ocular and non-ocular AEs.(3, 6, 12, and 36 months.)