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The Accuracy of Home Monitoring for Acute Macular Degeneration (AMD) Disease Activity

Primary Purpose

Acute Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home monitoring
Hospital assessment
Sponsored by
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Acute Macular Degeneration

Eligibility Criteria

60 Years - 99 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Patients over 60 years with a clinical diagnosis of neovascular age-related macular degeneration (ARMD), receiving treatment with intra-vitreal ranibizumab in accordance with current UK practice
  • At least 6 months of prior treatment beyond the loading phase of three fixed injections
  • At least 2 injections during the prior 6 months of the maintenance phase of treatment
  • Early Treatment for Diabetic Retinopathy Study (ETDRS) chart letter score at 2m of between 30 and 70 letters at the start of the study

Exclusion Criteria:

  • Patients with chronic intra-retinal cycts or sub-retinal fluid in the study eye on Optical coherence tomography (OCT) examination despite prior treatment and judged to be stable without the need for further treatment
  • Significant hearing impairment, felt likely to interfere with training and the telephone calls prior to the home monitoring
  • Lack of informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Intra-vitreal injection

    Arm Description

    Outcomes

    Primary Outcome Measures

    Monitor disease activity at home using near reading chart
    The reproducibility of the home monitoring assessment exercise

    Secondary Outcome Measures

    Full Information

    First Posted
    November 4, 2014
    Last Updated
    August 16, 2019
    Sponsor
    The Leeds Teaching Hospitals NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02304068
    Brief Title
    The Accuracy of Home Monitoring for Acute Macular Degeneration (AMD) Disease Activity
    Official Title
    The Accuracy of Home Monitoring for Disease Activity During Maintenance Therapy for Neovascular Age-related Macular Degeneration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    October 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Leeds Teaching Hospitals NHS Trust

    4. Oversight

    5. Study Description

    Brief Summary
    Currently the best treatment for "wet" macular degeneration involves regular injections of Ranibizumab (Lucentis). In the initial clinical trials, the drug was injected into the eye every month. Since then a number of studies have found similar benefits when the drug is given with a fixed number of injections initially and then with further injections only when needed. This approach has been adopted in the UK, following recommendation by the National Institute for Clinical Excellence (NICE). Although this approach reduces the expense and risk of un-necessary treatment, it does require regular hospital assessment of disease activity to determine if a repeat injection is required or can be deferred. The hospital assessment is time-consuming, inconvenient and the large number of assessments can cause delays in hospital follow-up. Using three different assessment criteria to monitor disease activity at home, the investigators plan to see if home monitoring is as good as hospital assessment. The investigators have already identified that many patients dislike the lengthy hospital assessment visit and would welcome the opportunity to do some of the monitoring of disease activity at home. The investigators have also shown that they understand and can complete each of the home assessment tests. In this pilot project, the investigators aim to get an idea of how reliable home monitoring can be in a small sample of just over 30 patients. The data that the pilot project generates will be used to influence and to help plan a subsequent, larger, national study to be submitted for funding to the National Institute for Health Research.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Macular Degeneration

    7. Study Design

    Study Phase
    Not Applicable

    8. Arms, Groups, and Interventions

    Arm Title
    Intra-vitreal injection
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    Home monitoring
    Intervention Type
    Other
    Intervention Name(s)
    Hospital assessment
    Primary Outcome Measure Information:
    Title
    Monitor disease activity at home using near reading chart
    Description
    The reproducibility of the home monitoring assessment exercise
    Time Frame
    7 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    99 Years
    Eligibility Criteria
    Inclusion Criteria: Patients over 60 years with a clinical diagnosis of neovascular age-related macular degeneration (ARMD), receiving treatment with intra-vitreal ranibizumab in accordance with current UK practice At least 6 months of prior treatment beyond the loading phase of three fixed injections At least 2 injections during the prior 6 months of the maintenance phase of treatment Early Treatment for Diabetic Retinopathy Study (ETDRS) chart letter score at 2m of between 30 and 70 letters at the start of the study Exclusion Criteria: Patients with chronic intra-retinal cycts or sub-retinal fluid in the study eye on Optical coherence tomography (OCT) examination despite prior treatment and judged to be stable without the need for further treatment Significant hearing impairment, felt likely to interfere with training and the telephone calls prior to the home monitoring Lack of informed consent

    12. IPD Sharing Statement

    Learn more about this trial

    The Accuracy of Home Monitoring for Acute Macular Degeneration (AMD) Disease Activity

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