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Study to Evaluate Home Vision Testing in Participants Who Receive Ranibizumab (Lucentis®)

2019年6月6日 更新者：Hoffmann-La Roche

Decentralized Pilot Study to Evaluate MyVisionTrack^TM Home Vision Testing in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration Currently Receiving Intravitreal Lucentis® Therapy.

This pilot study will evaluate home vision testing using a mobile medical application in participants with diabetic macular edema (DME) or neovascular age-related macula degeneration (nAMD) who receive intravitreal ranibizumab therapy. In the main, decentralized study, participants will be recruited via digital media, advocacy groups, or through their own ophthalmologist. The traditional substudy will evaluate the association between visual acuity and anatomical markers of disease status determined using clinical "gold standard" assessments (certified Early Treatment Diabetic Retinopathy Study [ETDRS] protocol visual acuity and macula optical coherence tomography [OCT]) and the results of home vision testing using the myVisionTrack^TM (mVT) application.

研究概览

地位

完全的

条件

干预/治疗

研究类型

观察性的

注册 (实际的)

47

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Utah
      • Salt Lake City、Utah、美国、84107
        • Rocky Mountain Retina

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Participants who are receiving treatment for DME or nAMD with intravitreal ranibizumab and are being evaluated at intervals of 4-8 weeks.

描述

Inclusion Criteria:

  • DME or active nAMD in at least one eye
  • Current treatment with intravitreal ranibizumab therapy, with evaluations planned every 4 to 8 weeks
  • Access to an approved mobile device with a data plan or WiFi internet access

Exclusion Criteria:

  • Any other eye condition causing eye disease that limits vision and cannot be corrected, other than DME or nAMD
  • Dementia or other neurologic or psychological limitation that would prevent the participant from performing regular self-testing of visual function

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Main Study
Decentralized participant recruitment, participant and local ophthalmologist compliance, and use of the mVT mobile medical application in a more geographically diverse, decentralized cohort of participants with DME or nAMD receiving intravitreal ranibizumab therapy as part of standard-of-care treatment.
其他：Ranibizumab
Ranibizumab administered as part of standard-of-care
Traditional Substudy
Subset of participants enrolled through a single investigator who will determine visual acuity and anatomical markers of disease status using clinical "gold standard" assessments (certified ETDRS protocol visual acuity and macula OCT).
其他：Ranibizumab
Ranibizumab administered as part of standard-of-care

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Number of "Clicks" on Study Information Advertisements on Participant Advocacy, Digital Media, and Professional Society Websites (Main Study Only)
大体时间：Baseline up to 6 months
Baseline up to 6 months
Percentage of Participants Participating at Specified Milestones in the Recruitment/Enrollment Process (Main Study Only)
大体时间：Baseline up to 6 months
Baseline up to 6 months
Percentage of Participants Performing Self-Testing Two Times per Week Using the Mobile Medical Application
大体时间：Baseline up to 6 months
Baseline up to 6 months
Percentage of Participants Visiting their Ophthalmologist at Least Every 8 Weeks (Main Study Only)
大体时间：Baseline up to 6 months
Baseline up to 6 months
Percentage of Office Visits for which Visual Acuity Data Were Provided to Scripps Translational Science Institute (STSI) (Main Study Only)
大体时间：Baseline up to 6 months
Baseline up to 6 months
Percentage of Office Visits for which OCT Data Were Provided to STSI (Main Study Only)
大体时间：Baseline up to 6 months
Baseline up to 6 months
Degree of Correlation Between mVT Test Results and Certified ETDRS Protocol Visual Acuity (Traditional Substudy Only)
大体时间：Baseline up to 6 months
Baseline up to 6 months
Degree of Correlation between mVT Test Results and OCT Characteristics (Traditional Substudy Only)
大体时间：Baseline up to 6 months
Baseline up to 6 months

次要结果测量

结果测量
大体时间
Association Between mVT Test Results and Routine Visual Acuity Measurements, Measured by Snellen or Other Standard-of-Care Visual Acuity Scores (Main Study Only)
大体时间：Baseline up to 6 months
Baseline up to 6 months
Total Number of Participants in the Enrolled Population (Main Study Only)
大体时间：Baseline up to 6 months
Baseline up to 6 months
Total Number of Participants in the Confirmed Population (Main Study Only)
大体时间：Baseline up to 6 months
Baseline up to 6 months
Differences Between the Participant's and their Ophthalmologist's Assessments of Eligibility (Main Study Only)
大体时间：Baseline up to 6 months
Baseline up to 6 months
Percentage of Photographed and Transmitted OCT Images that Are Gradable for Central Subfield Thickness
大体时间：Baseline up to 6 months
Baseline up to 6 months
Percentage of Participants Downloading the mVT Application who Require Assistance via Human Interaction from the Help Lines
大体时间：Baseline
Baseline
Number of Support Tickets Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application
大体时间：Baseline
Baseline
Total Support Time as an Average per Participant Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application
大体时间：Baseline
Baseline
Number of Additional Support (Calls/Interactions) Required by Participants
大体时间：Baseline up to 6 months
Baseline up to 6 months
Number of Critical Security Issues which May Require Reporting
大体时间：Baseline up to 6 months
Baseline up to 6 months
Number of Losses of Participant Data Due to Technical Issues
大体时间：Baseline up to 6 months
Baseline up to 6 months
Number of Data Processing Issues Occurring During the Study that Are Recoverable but Require Specific Effort, Indicating a Technical Problem
大体时间：Baseline up to 6 months
Baseline up to 6 months
Score of Participants Survey on Opinions Regarding Self-Monitoring
大体时间：At 1 week and 3 months after enrollment, at study completion/participant withdrawal (up to 6 months)
At 1 week and 3 months after enrollment, at study completion/participant withdrawal (up to 6 months)
Percentages of Substudy OCT Images (Photographs of the OCT Taken Using a Mobile Device), that Are Readable for Qualitative Assessment, Readable for Quantitative Assessment, or Indeterminate (Traditional Substudy Only)
大体时间：Baseline up to 6 months
Baseline up to 6 months
Percentage of Actual Substudy Downloaded OCT Images that Are Readable for the Presence of Cysts, Sub Retinal Fluid, and Pigment Epithelial Detachment, or Indeterminate (Traditional Substudy Only)
大体时间：Baseline up to 6 months
Baseline up to 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hoffmann-La Roche

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年4月20日

初级完成 (实际的)

2016年8月25日

研究完成 (实际的)

2016年8月25日

研究注册日期

首次提交

2015年4月14日

首先提交符合 QC 标准的

2015年4月14日

首次发布 (估计)

2015年4月17日

研究记录更新

最后更新发布 (实际的)

2019年6月10日

上次提交的符合 QC 标准的更新

2019年6月6日

最后验证

2019年6月1日

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

  • GE29720

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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