NCT04747197已完成1 期
A Phase 1, Multicenter, Prospective, Open-Label, Dose Escalation Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), in Subjects With Wet AMD
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs)
研究概览
简要总结
Phase 1 open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of a single dose injections of EYP-1901 at three dose levels: 440 µg, 2060 µg and 3090 µg in subjects with Wet Age Related Macular Degeneration (wAMD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with wet Age-Related Macular Degeneration (wAMD), in the study eye.
- •Subject must have received ≥3 prior injections with the same anti-VEGF product: bevacizumab, ranibizumab, or aflibercept) in the 6 months prior to the Screening Visit, in the study eye.
- •Demonstrated response to the intravitreal anti-vascular endothelial growth factor (VEGF) treatment in the study eye.
- •Best-corrected visual acuity (BCVA) using ETDRS charts of 25 letters (20/320 Snellen equivalent) to 85 letters (20/20 Snellen equivalent).
排除标准
- •History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye.
- •Subfoveal fibrosis or scarring >50% of the total lesion, or atrophy in the study eye, confirmed by central reading center.
- •Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia that would compromise vision in the study eye, confirmed by central reading center.
- •Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of the study results.
- •Active intraocular inflammation (grade trace or above) in the study eye.
- •History of rhegmatogenous retinal detachment or treatment for retinal detachment or macular hole (stage 3 or 4) in the study eye.
- •History of idiopathic or autoimmune-associated uveitis in either eye.
- •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- •History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye.
研究组 & 干预措施
440 ug, single dose
Experimental
EYP-1901 440 ug, single dose
干预措施: EYP-1901 (Drug)
2060 ug, single dose
Experimental
EYP-1901 2060 ug, single dose
干预措施: EYP-1901 (Drug)
3090 ug, single dose
Experimental
EYP-1901 3090 ug, single dose
干预措施: EYP-1901 (Drug)
结局指标
主要结局
Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs)
时间窗: Week 48
Number of ocular (study eye) and systemic TEAEs during the treatment period - Intent-to-Treat (ITT) Population
次要结局
- Change in best corrected visual acuity (BCVA) by EDTRS(Baseline, Week 48)
- Mean change in central subfield thickness (CST)(Baseline, Week 48)
研究者
研究点 (2)
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