NCT06550011进行中（未招募）1 期
A Phase 1/2a, Open-Label, Multiple-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IVT) Injection of ABI-110 (AAV2.N54- VEGF Trap) in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Including Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This will be a clinical study to assess initial safety and tolerability of IVT ABI-110 in patients diagnosed with wet macular degeneration (wAMD), including symptomatic macular PCV.
详细描述
This is a Phase 1/2a, open-label, multiple-cohort, dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of IVT ABI-110 (AAV2.N54-VEGF-Trap) injection in subjects with wAMD), including symptomatic macular PCV.
This trial will include a screening period, confirmation of response to EYLEA (aflibercept), single administration of ABI-110, and follow-up period of 104 weeks after IVT ABI-110 injection.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be willing and able to provide written, signed informed consent.
- •Age: Subjects ≥ 50 and ≤ 89 years of age at the time of signing the informed consent
- •Diagnosis of wAMD, including symptomatic macular PCV, confirmed by the Central Reading Center
- •The macular neovascularization lesion must be confirmed as determined by the Central Reading Center based on SD-OCT imaging at screening.
- •BCVA ≤ 20/25 and ≥ 20/250 (≤ 80L and ≥ 30L ETDRS letters)
- •History of ≥ 2 anti-VEGF injections prior to trial entry with meaningful response to anti-VEGF and continued need for anti-VEGF treatment
- •Response to anti-VEGF at trial entry
排除标准
- •Study or Fellow Eye:
- •Prior gene therapy, either eye
- •Any active ocular/intraocular infection or inflammation (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis) or history of idiopathic or autoimmune-associated uveitis, either eye
- •History of retinal disease other than wAMD or PCV, study eye
- •Any condition preventing visual acuity improvement (e.g., fibrosis, atrophy, or retinal epithelial tear in the center of the fovea), study eye.
- •History of (or active) retinal detachment, study eye
- •Uncontrolled glaucoma (defined as IOP > 25 mmHg despite treatment), study eye, or history of steroid-response ocular hypertension/glaucoma in either eye
- •History of intravitreal therapy, (other than anti-VEGF therapy) such as intravitreal steroid injection or investigational product, in the 6 months prior to screening, study eye
- •Any prior treatment with photodynamic therapy or laser photocoagulation, study eye
- •History of glaucoma filtration, vitrectomy, or other procedure that could affect drug distribution or clearance, study eye.
研究组 & 干预措施
Dose level 1
Experimental
Low Dose
干预措施: ABI-110 Low Dose (Drug)
Dose level 2
Experimental
Medium Dose
干预措施: ABI-110 Medium Dose (Drug)
Dose level 3
Experimental
High Dose
干预措施: ABI-110 High Dose (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 52 weeks
Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]
次要结局
- Preliminary Efficacy(52 weeks)
- Pharmacokinetics and Pharmacodynamics(52 weeks)
- Immunogenicity(52 weeks)
- Optimal Dose(52 weeks)
研究者
研究点 (4)
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