Natural History Study of Advanced RCD (ECSTASI)
External Control, preScreening, and naTurAl hiStory of Advanced retInal Degeneration Due to Rod-cone Dystrophy (ECSTASI)
ECSTASI is a Natural History Study, which will be monitoring how standard of care (SoC) affect advanced rod-cone dystrophy (RCD), a type of eye disease also known as retinitis pigmentosa. No experimental, investigational or any other drug or treatment will be tested during the study.
This study collects information in 3 parts:
Part 1: retrospective health information from medical records (up to past 10 years), Part 2: prospective health information from in-person visits (up to 1 year), and Part 3: prospective health information from medical records (up to 1 year). Participants will decide if they wish to participate in all or only to some of these parts.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Medical Director
研究联系人备份
- 姓名：SparingVision
- 电话号码：+33143462060
- 邮箱：info@sparingvision.com
学习地点
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Ghent、比利时
- 招聘中
- Ghent University Hospital
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接触：
- Ophthalmic Clinical Trials Unit
- 邮箱：OCTU@uzgent.be
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首席研究员：
- Bart Leroy, Prof
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Paris、法国
- 尚未招聘
- CHNO XV-XX Paris - CIC 1423
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接触：
- Isabelle Audo, Prof.
- 电话号码：00 33 1 40 02 14 57
- 邮箱：isabelle.audo@inserm.fr
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首席研究员：
- Isabelle Audo, Dr
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Dublin、爱尔兰
- 尚未招聘
- Royal Victoria Eye And Ear Hospital
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接触：
- 电话号码：00 353 1 664 4600
- 邮箱：Emma.duignan@rveeh.ie
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首席研究员：
- Emma Duignan, Dr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Males and females 18 years of age or older, with history of formed vision
- Clinical diagnosis of advanced retinal degeneration due to RCD
- BCVA no better than (≥) 1.0 LogMAR (≤35 Early-Treatment Diabetic Retinopathy Study [ETDRS] letters, or 20/200 Snellen equivalent) in at least one eye
- Documented preservation of foveal Outer Nuclear Layer (ONL) in at least one eye
Exclusion Criteria:
- Individuals who are receiving or have received an investigational medicinal product (IMP) in another clinical trial are excluded from the prospective part . However, they can participate in the retrospective part of the study.
- Individuals with a medical condition (systemic or ophthalmic), psychiatric condition (including substance abuse disorder), physical examination or laboratory findings that may in the opinion of the Investigator preclude adherence to the scheduled study visits, safe participation in the study, or affect study results are excluded from participating in in-person study visits. However, they can participate in the collection of data reported during both retrospective and prospective SoC routine eye examinations.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Prospective and/or retrospective data collection
This Natural History study is designed as a combination of prospective and retrospective evaluations in patients diagnosed with advanced RCD. Prospective data will be collected during in-person study visits and/or SoC routine eye examinations (not planned per protocol) as they are reported in the medical records of the participant for up to 1 year after study enrollment. Retrospective data will be collected from the medical records of the participant for up to 10 years before enrollment. |
Routine eye examinations (including slit lamp exam and dilated fundus exam), standard visual assessments (such as best corrected visual acuity test and ocular coherence tomography), evaluation of visual function (such as microperimetry). Patient-reported quality of life questionnaire. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Best-corrected visual acuity (BCVA)
大体时间：At 6 months
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Change in BCVA from Baseline to Month 6 |
At 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To evaluate the effects of SoC on visual function at 1 year of follow up
大体时间：At 1 year
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Change in BCVA from baseline to Year 1 |
At 1 year
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To determine the precision and reliability of the assessments of visual function measured in ECSTASI
大体时间：1 year
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Test-retest variability and signal-to-noise ratio of visual function measurements such as BCVA and microperimetry. |
1 year
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To evaluate participant potential eligibility for the Phase 1/2a clinical trial of SPVN20 (NYRVANA).
大体时间：1 year
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Percentage of participants potentially eligible to participate in the Phase 1/2a clinical trial of SPVN20 (NYRVANA), based on data collected in the ECSTASI study. |
1 year
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To evaluate the effects of SOC on visual function at 6 months and 1 year of follow-up for FST
大体时间：1 year
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Change in FST from baseline to Month 6 and Year 1 |
1 year
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To evaluate the effects of SOC on visual function at 6 months and 1 year of follow-up for microperimetry
大体时间：1 year
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Change in microperimetry foveal sensitivity from baseline to Month 6 and Year 1 |
1 year
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To evaluate the effects of SOC on visual function at 6 months and 1 year of follow-up for eye dominance
大体时间：1 year
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Change in eye dominance from baseline to Month 6 and Year 1 |
1 year
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- SPVN-NHS-03
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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研究美国 FDA 监管的设备产品
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