Everads Injector in Suprachoroidal Administration of a Triamcinolone Acetonide (TA) Suspension Approved for Intraocular Injection, for the Treatment of Patients With Diabetic Macular Edema: An Open-label Safety and Performance Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Frequency of treatment-emergent adverse events
研究概览
简要总结
This is an open-label pilot device study. The aim of the study is to evaluate the safety and performance of Everads Injector following single injection of suspension approved for ocular use into the suprachoroidal space.
The study population is patients diagnosed with diabetic macular edema (DME) that were previously treated. 10 adult subjects are expected to be enrolled based on the inclusion-exclusion criteria.
The study will involve 6 visits during a period of 6 weeks
详细描述
The study involves 6 visits: Screening Visit: Visit 1 (Day -6 to 0); Baseline and Injection Visit: Visit 2 (Day 1); Follow up visits: Visit 3 (Day 3 ± 1 Days), Visit 4 (Day 14 ± 3 Days), Visit 5 (Day 28 ± 3 Days); End of Trial: Visit 6 (Day 42 ± 3 Days).
Patient eligibility will be assessed at screening, and the study eye will be determined.
Baseline/Injection Visit will include a pre-injection examination, injection of TA and post-injection examination The study eye will receive the suprachoroidal injection of TA injectable suspension approved for ocular use. The Everads Injector will be used for a single administration of 100 µl (4 mg) of TA into the suprachoroidal space in the treatment eye.
Injections using Everads Injector will be performed by trained and qualified investigators after training by Sponsor experts
Study assessments include: physical examination, vital signs, medical & ocular history, AE and concomitant medication assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Males and females ≥ 18 years of age with a diagnosis of type 1 or type 2 diabetes mellitus.
- •Diagnosis of DME with confirmed central involvement of ≥ 320 µm for males and ≥ 305 µm for females on Spectralis (Heidelberg) or ≥ 305 µm for males and ≥ 290 µm for females with Cirrus (Zeiss) by spectral domain optical coherence tomography (SD-OCT), verified at the screening visit.
- •First three patients: ETDRS BCVA letter score of worse than 35 (Snellen equivalent of 20/200 imperial or 6/60 metric) in the study eye, and ETDRS BCVA of 60 (Snellen equivalent of 20/63 imperial or 6/19 metric) or better in the fellow eye. Remaining patients: ETDRS BCVA letter score of worse than 50 (Snellen equivalent of 20/100 imperial or 6/30 metric) in the study eye, and ETDRS BCVA of 60 (Snellen equivalent of 20/63 imperial or 6/19 metric) or better in the fellow eye.
- •Have shown no response to three previous Intravitreal (IVT) treatments with anti-vascular endothelial growth factor (VEGF) agents.
排除标准
- •Evidence of macular edema of any cause other than diabetic retinopathy in the study eye.
- •Prior treatment with pan-retinal photocoagulation or focal laser photocoagulation in the study eye within 90 days of screening visit.
- •Intraocular pressure ≥ 21 mmHg or uncontrolled glaucoma (open-angle or angle-closure) in the study eye.
- •History of any prior ophthalmic surgeries in the study eye within 90 days of the screening visit.
- •Previous treatment for DME in the study eye with any intravitreal injection in the 30 days prior to the screening visit.
- •Any previous treatment with Ozurdex® implant in past 6 months.
- •Any previous treatment with Iluvien® or Retisert™.
- •Current iris neovascularization, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane that contributes to macular edema in the study eye, per PI discretion.
- •Uncontrolled blood pressure.
- •HbA1c >12%.
研究组 & 干预措施
Open-label prospective device study
Treatment of previously treated patients diagnosed with diabetic macular edema (DME)
干预措施: Everads Injector (Device)
结局指标
主要结局
Frequency of treatment-emergent adverse events
时间窗: 6 weeks
Frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (6 weeks) TEAEs are defined as events that emerge following administration of TA via the Everads Injector.
Frequency of adverse device effects
时间窗: 6 weeks
Frequency of adverse device effects and frequency of serious adverse device effects (SADEs) throughout the study period (6 weeks) Adverse device effects and SADEs are defined as effects that emerge following the use of the Everads Injector.
次要结局
- Change from baseline in central macular thickness(6 weeks)
- Confirmation of TA delivery into the suprachoroidal space(Injection day)