A Non-randomised, Open-label, Multicenter Phase 4 Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies With or Without Intravitreal Corticosteroid Therapy (RESPOND)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Changes in best-corrected visual acuity (BCVA) from baseline to Month-12
研究概览
简要总结
To provide treating physicians with experience with ILUVIEN as well as monitoring its safety (and effectiveness) in a real-life chronic diabetic macular edema (DME) patients judged insufficiently responsive to available therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults (≥18 years) with chronic DME;
- •Patients considered as insufficiently responsive as defined as having underwent other previous treatments, including at least 3 anti-VEGF injections in the last 6 months, and the following:
- •Mean central foveal thickness (central subfield thickness) ≥ 290 um in women and ≥ 305 um in men in Zeiss Cirrus OR ≥ 305 um in women and ≥ 320 um in men in Heidelberg Spectralis, in the study eye as measured using SD-OCT;
- •Vision impairment (20/50 to 20/400 using Snellen visual acuity equivalent) related to DME;
- •If in the Investigator's opinion a further improvement is possible.
排除标准
- •IOP > 21 mmHg at screening (day -14) in the study eye.
- •Historical rise in IOP > 25 mmHg following treatment with an intravitreal corticosteroid in the study eye.
- •Use of ≥ 2 active agents as IOP-lowering medications to control IOP at screening in the study eye.
- •Vitreomacular traction in DME and opaque media in the study eye.
- •Severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye.
- •Pregnant or breastfeeding women.
- •Active angiographic central macular ischaemia before baseline in the study eye.
- •Pan retinal photocoagulation or cataract surgery 3 months before baseline in the study eye.
- •Presence of pre-existing glaucoma, active or suspected ocular or periocular infection and/or hypersensitive to the active agent or to one of the excipients.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are: using a highly effective method of birth control.
研究组 & 干预措施
ILUVIEN 190 ug intravitreal implant
All patients will receive ILUVIEN 190 micrograms intravitreal implant in applicator with an initial release rate of 0.2 microgram per day. The implant will be administered by injection according to the method of administration defined in the SmPC (ILUVIEN SmPC). Only one eye of each patient will be treated with ILUVIEN.
干预措施: IlUVIEN (Drug)
结局指标
主要结局
Changes in best-corrected visual acuity (BCVA) from baseline to Month-12
时间窗: Baseline to 12 months
Changes in central retinal thickness assessed using spectral domain optical coherence tomography (SD-OCT) from baseline to Month-12
时间窗: Baseline to 12 months
Occurrence of Adverse events, namely cataract and elevated IOP
时间窗: 12 months
次要结局
未报告次要终点