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.
調査の概要
研究の種類
観察的
入学 (実際)
47
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Utah
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Salt Lake City、Utah、アメリカ、84107
- Rocky Mountain Retina
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Participants who are receiving treatment for DME or nAMD with intravitreal ranibizumab and are being evaluated at intervals of 4-8 weeks.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
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Ranibizumab administered as part of standard-of-care
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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).
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Ranibizumab administered as part of standard-of-care
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Number of "Clicks" on Study Information Advertisements on Participant Advocacy, Digital Media, and Professional Society Websites (Main Study Only)
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Percentage of Participants Participating at Specified Milestones in the Recruitment/Enrollment Process (Main Study Only)
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Percentage of Participants Performing Self-Testing Two Times per Week Using the Mobile Medical Application
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Percentage of Participants Visiting their Ophthalmologist at Least Every 8 Weeks (Main Study Only)
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Percentage of Office Visits for which Visual Acuity Data Were Provided to Scripps Translational Science Institute (STSI) (Main Study Only)
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Percentage of Office Visits for which OCT Data Were Provided to STSI (Main Study Only)
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Degree of Correlation Between mVT Test Results and Certified ETDRS Protocol Visual Acuity (Traditional Substudy Only)
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Degree of Correlation between mVT Test Results and OCT Characteristics (Traditional Substudy Only)
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Association Between mVT Test Results and Routine Visual Acuity Measurements, Measured by Snellen or Other Standard-of-Care Visual Acuity Scores (Main Study Only)
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Total Number of Participants in the Enrolled Population (Main Study Only)
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Total Number of Participants in the Confirmed Population (Main Study Only)
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Differences Between the Participant's and their Ophthalmologist's Assessments of Eligibility (Main Study Only)
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Percentage of Photographed and Transmitted OCT Images that Are Gradable for Central Subfield Thickness
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Percentage of Participants Downloading the mVT Application who Require Assistance via Human Interaction from the Help Lines
時間枠：Baseline
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Baseline
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Number of Support Tickets Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application
時間枠：Baseline
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Baseline
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Total Support Time as an Average per Participant Needed for Technician/Coordinator Interactions with the Participant to Download the mVT Application
時間枠：Baseline
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Baseline
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Number of Additional Support (Calls/Interactions) Required by Participants
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Number of Critical Security Issues which May Require Reporting
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Number of Losses of Participant Data Due to Technical Issues
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Number of Data Processing Issues Occurring During the Study that Are Recoverable but Require Specific Effort, Indicating a Technical Problem
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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Score of Participants Survey on Opinions Regarding Self-Monitoring
時間枠：At 1 week and 3 months after enrollment, at study completion/participant withdrawal (up to 6 months)
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At 1 week and 3 months after enrollment, at study completion/participant withdrawal (up to 6 months)
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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)
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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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)
時間枠：Baseline up to 6 months
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Baseline up to 6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2015年4月20日
一次修了 (実際)
2016年8月25日
研究の完了 (実際)
2016年8月25日
試験登録日
最初に提出
2015年4月14日
QC基準を満たした最初の提出物
2015年4月14日
最初の投稿 (見積もり)
2015年4月17日
学習記録の更新
投稿された最後の更新 (実際)
2019年6月10日
QC基準を満たした最後の更新が送信されました
2019年6月6日
最終確認日
2019年6月1日
詳しくは
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