NCT06015633进行中（未招募）不适用
Exploration of Ocular, Vascular, and Genetic Findings Associated and Correlated with the Presence of Late-stage AMD
OcuDyne, Inc.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年10月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- OCT-A
研究概览
简要总结
Observation of findings associated with AMD
详细描述
Explorational observation of ocular, vascular, and genetic findings in patients diagnosed with AMD
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •At least 55 years of age at the time of consent
- •Able to understand and provide written informed consent
- •Sufficiently clear ocular media, adequate pupillary dilation, and adequate fixation to permit quality fundus imaging
- •Able to cooperate with ophthalmic visual function testing and anatomic assessments
- •Diagnosed with late-stage AMD in at least one eye. (if both eyes of an eligible subject meet inclusion criterion, the more advanced eye will receive primary eye assignment)
- •Willing to have protocol specified genetic testing
- •Willing to have head coil MRI/A (with contrast if deemed necessary)
排除标准
- •History of any retinal disease other than AMD in either eye
- •Spherical equivalent refractive error demonstrating >6 diopters of myopia or an axial length >26 mm in the study eye
- •History of vitrectomy in the study eye
- •Any intraocular surgery (including lens replacement surgery) in the study eye, within 90 days of enrollment
- •History of endophthalmitis
- •Trabeculectomy or aqueous shunt or valve in the study eye
- •Aphakia or absence of the posterior capsule in the study eye (Note: Previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet [YAG] laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 90 days prior to enrollment)
- •Presence of advanced guttae or visually significant keratopathy that would cause scattering of light or alter visual function in the study eye
- •History of idiopathic or autoimmune-associated uveitis in either eye
- •Active inflammation or infection, including conjunctivitis, keratitis, or scleritis in either eye
- •GA secondary to a condition other than AMD (e.g., Stargardt's disease, cone rod dystrophy, or toxic maculopathies such as Plaquenil maculopathy) in either eye
- •Use of any investigational product or investigational medical device (i.e., not approved by FDA for the specific use) within 90 days prior to screening or anticipated use during the study
- •Women of childbearing potential who are pregnant or unwilling to use effective contraception for the duration of the study
- •Acute or serious illness, in the opinion of the site investigator
- •History of kidney failure or gadolinium toxicity
结局指标
主要结局
OCT-A
时间窗: Baseline observation of incidence / correlation only
OCT-A metrics in subjects with AMD
次要结局
- Magnetic Resonance Angiography(Baseline observation of incidence / correlation only)
- Genetic markers related to AMD(Baseline observation of incidence / correlation only)
研究者
研究点 (1)
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