A Multi-Center, Open-label, 24-week Clinical Investigation to Evaluate Safety and Tolerability of Treatment With the Oxulumis®, Suprachoroidal Drug Administration Device Delivering 2.4mg Triesence® With Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Frequency of adverse device effects and frequency of serious adverse device effects
研究概览
简要总结
The purpose of this clinical investigation is to evaluate the safety and tolerability of using the Oxulumis® microcatheterization device to administer Triesence® to the suprachoroidal space in participants with DME.
详细描述
This 24-week, single-arm, single-dose clinical investigation will evaluate the safety and tolerability and explore the efficacy of the Oxulumis® microcatheterization device to administer Triesence® (triamcinolone acetonide suspension) 2.4 mg to the posterior suprachoroidal space in subjects with DME not responding to standard therapy.
After a screening period, approximately 20 eligible subjects will receive a single dose of 2.4 mg Triesence® to the posterior suprachoroidal space.
The follow-up period after treatment administration will be up to 24 weeks.
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
- •Have been diagnosed with Type 1 or Type 2 diabetes mellitus.
- •Have Diabetic Macular Edema (DME) involving the center of the fovea in the study eye with a central retinal thickness (CRT), at the screening visit, of≥ 320 for males or ≥ 305 for females on Spectralis (Heidelberg) or ≥ 305 for males or ≥ 290 for females with Cirrus (Zeiss) by spectral domain optical coherence tomography (SD-OCT).
- •Have a best-corrected visual acuity (BCVA) in the study eye between 34 and 68 letters ETDRS at the screening visit.
- •Have shown limited response to previous IVT treatment with anti-vascular endothelial growth factor (VEGF) agents or local corticosteroid treatment (IVT, subtenon, topical) defined as less than 20% reduction of central subfield thickness (CST) with previous treatments.
- •Study eye suitable for suprachoroidal injection in the investigator's judgment in agreement with the medical monitor. Patients with ocular hypotony or structural abnormalities like choroidal coloboma or chorioretinal anastomosis, amongst others, are not eligible.
排除标准
- •Presence of any other ocular condition in the study eye such that visual acuity may not improve from the resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, or nonretinal causes).
- •Active proliferative diabetic retinopathy (PDR) or sequelae of PDR (including iris neovascularization, vitreous hemorrhage, or tractional retinal detachment) at screening in the study eye.
- •Pan-retinal photocoagulation (PRP) or macular laser photocoagulation in the study eye performed within sixteen (16) weeks before screening.
- •Prior IVT treatment with anti-VEGF in the study eye: last injection with ranibizumab or bevacizumab within four (4) weeks, aflibercept or brolucizumab within eight (8) weeks, faricimab within twelve (12) weeks before screening
- •Prior ocular treatment with steroids in the study eye: last injection (intra- or periocular) with triamcinolone acetonide within three (3) months, with dexamethasone implant (Ozurdex®) within six (6) months before screening.
- •Prior treatment with longer duration steroid implants (e.g., fluocinolone acetonide IVT implant, Iluvien®) is not allowed.
- •Prior treatment with suprachoroidal steroids is not allowed.
结局指标
主要结局
Frequency of adverse device effects and frequency of serious adverse device effects
时间窗: 24 Weeks
Adverse device effects and serious adverse device effects are defined as effects that emerge following the administration of the Oxulumis microcatheter at Visit 2 (Baseline, Day 0)
Frequency of ocular adverse events, systemic adverse events, serious, and treatment-emergent non-serious adverse events
时间窗: 24 Weeks
Treatment-emergent adverse events are defined as an event that emerges following administration of Triesence with the Oxulumis microcatheter administered at Visit 2 (Baseline, Day 0)
次要结局
未报告次要终点