NCT07392255
招募中
1 期
A First in Human Phase 1 / 2 Multi-center Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of CTx001 Administered Via a Single Subretinal Injection in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Complement Therapeutics3 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年12月30日最近更新:
干预措施CTx001
概览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Complement Therapeutics
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- To monitor the safety and tolerability of a single administration of CTx001 at 3 dose levels
概览
简要总结
This is a clinical study to evaluate the safety, tolerability and efficacy of CTx001, administered via a single subretinal injection, for GA (secondary to AMD).
Safety and efficacy will be measured at regular intervals for 2 years after which long-term safety will be assessed annually for up to 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet protocol-defined age eligibility
- •Have bilateral geographic atrophy secondary to AMD, confirmed by the Reading Center
- •Meet baseline lesion size requirements, as assessed by fundus autofluorescence imaging
- •Meet best-corrected visual acuity and low-luminance visual acuity criteria, as measured by ETDRS charts
- •Meet retinal sensitivity criteria, as measured by microperimetry
- •Have sufficient fellow-eye visual function to ensure navigational vision
- •Have adequate historical SD-OCT imaging available for longitudinal assessment
- •Meet reproductive status and contraception requirements, where applicable
- •Be able and willing to provide informed consent and comply with study procedures
排除标准
- •Macular atrophy or retinal disease not attributable to AMD
- •Evidence of current or prior choroidal neovascularization (wet AMD)
- •Prior intraocular, macular, or retinal surgery or laser treatment that may confound assessments
- •Prior AMD-directed or intravitreal therapy in the study eye, except permitted supplements
- •Prior exposure to complement inhibitor therapies
- •Ocular conditions, infections, inflammation, or media opacities that interfere with safety or retinal imaging
- •Uncontrolled glaucoma, diabetic retinopathy, or clinically significant refractive error
- •Aphakia or compromised posterior capsule, except as permitted by protocol
- •Systemic medical or psychiatric conditions that may increase risk or limit compliance
- •Recent participation in another interventional clinical study or exposure to investigational therapies
研究组 & 干预措施
Cohort 1
Experimental
Low Dose
干预措施: CTx001 (Genetic)
Cohort 2
Experimental
Medium Dose
干预措施: CTx001 (Genetic)
Cohort 3
Experimental
High Dose
干预措施: CTx001 (Genetic)
Cohort 4
Experimental
Expansion of a dose selected from Cohort 1-3
干预措施: CTx001 (Genetic)
Cohort 5
Experimental
Expansion of a second dose selected from Cohort 1-3
干预措施: CTx001 (Genetic)
结局指标
主要结局
To monitor the safety and tolerability of a single administration of CTx001 at 3 dose levels
时间窗: From dosage to Week 52
Incidence and severity of ocular and non-ocular adverse events (AE)s and serious AEs (SAEs) up to Week 52 (Year 1)
次要结局
- To evaluate the preliminary efficacy of treatment with CTx001 through changes in the structural and functional parameters of geographic atrophy (GA)(From dosage to Year 1)
- To evaluate the preliminary efficacy of treatment with CTx001 through changes in the structural and functional parameters of geographic atrophy (GA)(From dosage to Year 2)
- To monitor the long-term safety and tolerability of a single administration of CTx001 at 3 dose levels(From dosage up to Week 260 (Year 5))
- To assess immunogenicity to adeno-associated virus Serotype 2 (AAV2)-vector and mini-CR1 transgene product(From dosage up to Week 260 (Year 5))
研究者
研究点 (3)
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