NCT06825858进行中（未招募）1 期
A Phase I, Open-label, Multicenter, Dose-Escalating Study to Evaluate the Safety and Tolerability of KH658 Gene Therapy in Participants With Neovascular Age-related Macular Degeneration
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
- 9
- 试验地点
- 3
- 主要终点
- Safety
研究概览
简要总结
VAN-2401 is Phase I clinical trial to assess the safety and tolerability of KH658 in subjects with neovascular AMD. KH658 is gene therapy designed to deliver a protein which targets and blocks VEGF via an adeno-associated viral vector. The standard of care for patients with neovascular AMD are anti-VEGF treaments, which have demonstrated improvement in vision and reduction in fluid. A one time placement of a product which inhibits VEGF has the potential to reduce the patient burden of regular ocular injections.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Males and Females ages 50 to 85 (inclusive) with a study eye which meets the following criteria:
- •a. Previously received IVT treatment of anti-VEGF for neovascular AMD, with documented response to anti-VEGF therapy during the first 2 weeks of screening b. active macular CNV lesion secondary to AMD evidenced by SD-OCT c. Have a ETDRS BCVA letter score of 63 to 25 in the study eye at Screening for the first subject in each cohort (sentinel subject), followed by ETDRS BCVA letter score of 73 to 25 for the rest of the subjects each cohort; d. Are willing and able to sign the study written informed consent form (ICF).
排除标准
- •1. Have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular AMD except IVT anti-VEGF
- •Retinal pigment epithelial tears or rips at screening
- •Any history or presence of vitreous hemorrhage;
- •Have any condition preventing visual acuity improvement;
- •Have any other cause of CNV; prior pars plana vitrectomy or scleral buckling or retinal detachment surgery; macular hole, Epiretinal membrane or vitreo-macular traction; full thickness macular hole;
- •History of intraocular or periocular surgery in the prior 3 months;
- •Prior trabeculectomy or other filtration surgery (SLT or MIGS are permitted);
- •corneal transplant;
- •Any use of long-acting intraocular steroids, including implants, within six months prior;
- •Uncontrolled glaucoma;
- •Intraocular implant
- •Participated as a subject in any interventional clinical trial within 1 month prior;
- •Have received any gene or cell therapy product at any time in the past (either eye or systemically);
- •Have active intraocular inflammation in either eye at Screening or a history of uveitis in either eye 15.Have active ocular or periocular infection in either eye;
- •Have presence or history of scleromalacia in either eye;
研究组 & 干预措施
KH658 Dose 2
Experimental
KH658 One-Time Suprachroidal Space delivery Dose Level 2
干预措施: KH658 (Drug)
KH658 Dose 3
Experimental
KH658 One-Time Suprachroidal Space delivery Dose Level 3
干预措施: KH658 (Drug)
KH658 Dose 1
Experimental
KH658 One-Time Suprachroidal Space delivery Dose Level 1
干预措施: KH658 (Drug)
结局指标
主要结局
Safety
时间窗: 24Weeks
type, severity and incidence of ocular and systemic AEs and SAEs
Rescue Injections
时间窗: 52Weeks
Mean Number of Rescue Injections
Safety
时间窗: 52 Weeks
type, severity and incidence of ocular and systemic AEs and SAEs
Rescue Injections
时间窗: 24Weeks
Mean Number of Rescue Injections
次要结局
- Safety(24 Weeks)
研究者
研究点 (3)
Loading locations...
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