NCT04358471撤回2 期
A Phase 2 Multi-Center Trial Evaluating Intravitreal AAVCAGsCD59 Compared to Sham Injection for the Treatment of Advanced Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA)
Hemera Biosciences0 个研究点开始时间: 2021年7月31日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Evaluate the change in Geographic Atrophy area (mm2) measured at Day 0 and compared to the measurement at Month 24
研究概览
简要总结
Patients with advanced dry AMD with GA meeting inclusion criteria will be randomized in one eye in a 1:1:1 ratio comparing intravitreal high or low dose AAVCAGsCD59 with a sham injection. All enrolled subjects will be followed for 24 months to evaluate reduction in GA growth and safety of intravitreal AAVCAGsCD59.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced dry AMD with GA in the study eye
- •BCVA in the study eye of 80 or less ETDRS letters (Snellen equivalent 20/25 or worse)
- •Total cumulative GA lesion size 2.5 mm2 to 12.5 mm2 in the study eye as confirmed by the reading center during the Screening Period.
排除标准
- •GA secondary to non-AMD etiologies in the study eye (i.e. myopia, inherited retinal diseases).
- •GA associated with the presence of an RPE rip.
- •GA contiguous with peripapillary atrophy.
- •Active CNV secondary to wet AMD in the study eye and currently receiving anti-VEGF ocular treatment within the previous 18 months.
- •Subretinal fibrosis in the macula from CNV both clinically and imaged on SD-OCT in the macula.
- •Previous macular laser photocoagulation (i.e. focal or grid laser for macular edema), photodynamic therapy (PDT), ocular/orbital radiation, laser to CNV, or subretinal surgery for CNV in the study eye.
- •History of conditions in the study eye which might alter visual acuity or interfere with study testing including proliferative diabetic retinopathy (PDR), clinically significant macular edema (CSME), central retinal vein occlusion (CRVO), hemi retinal vein occlusion (HRVO), macular branch retinal vein occlusion, and optic neuropathy.
- •Active uncontrolled glaucoma with at least one of the following: IOP>30 mmHg despite maximum medical treatment with glaucoma medications, cup-to-disc ratio of >0.9, visual field defects secondary to glaucoma that involve the macula, or optic atrophy from glaucoma.
- •Active acute or chronic infectious uveitis, retinitis, or conjunctivitis (excluding blepharitis)
结局指标
主要结局
Evaluate the change in Geographic Atrophy area (mm2) measured at Day 0 and compared to the measurement at Month 24
时间窗: 24 Months
Geographic atrophy will be measured based on imaging of the retina
次要结局
- Incidence of conversion from dry to wet age-related macular degeneration(24 Months)
- Change in visual acuity of the AAVCAGsCD59 treated eye(24 Months)
研究者
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