跳至主要内容
临床试验/NCT04558983
NCT04558983终止不适用

A Natural History Study to Evaluate Functional and Anatomical Progression in Retinitis Pigmentosa

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
32
试验地点
1
主要终点
Change in mean macular sensitivity (dB) over time as assessed by microperimetry

研究概览

简要总结

This study will assess the progression of RP as seen on newer modalities including spectral-domain optical coherence (SD-OCT) and macular assessment integrity (MAIA) microperimetry to evaluate disease status. Understanding the natural history of the disease is not only essential to monitoring and comparing patient populations in clinical trials. It is also fundamental in the predevelopment phase in order to optimize the study duration needed to observe a statistically significant outcome. Furthermore, since the progression of RP is usually slow, relying on traditional tests can take an unfeasible length of time to observe any meaningful changes and assess therapeutic efficacy for new drugs. Therefore, the results of this study will be beneficial in establishing reliable endpoints and outcome measures for future clinical trials. Such outcome measures may be able to detect treatment response with more precision. More importantly, investigators may be able to detect changes early enough to prevent irreversible vision loss.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older
  • Patients diagnosed with Retinitis Pigmentosa
  • Ability to provide informed consent
  • Ability to authorize use and disclosure of protected health information

排除标准

  • Concomitant ocular pathology that limits central macular function, including but not limited to age-related macular degeneration, diabetic retinopathy, and retinal vein occlusion
  • If EZ width ≤200µm

结局指标

主要结局

Change in mean macular sensitivity (dB) over time as assessed by microperimetry

时间窗: Baseline, every six months up to 2 years

Microperimetry (MAIA) will be used to test whether there is a change in sensitivity (dB) in the macula

次要结局

  • Change in mean retinal sensitivity(Baseline and at 2 years)
  • Correlation between change in visual functional measures and Quality of Life survey metrics(Baseline, every year up to 2 years)
  • Change in Best Corrected Visual Acuity (BVCA)(Baseline, every six months up to 2 years)
  • Change in Ellipsoid Zone (EZ) width(Baseline, every six months up to 2 years)
  • Change in Quality of Life survey metrics(Baseline, every year up to 2 years)
  • Correlation between change in visual functional and anatomical measures(Baseline, every six months up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验