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

NCT02304068 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-08-20

No results posted yet for this study

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.

Conditions

  • Acute Macular Degeneration

Interventions

OTHER

Home monitoring

OTHER

Hospital assessment

Sponsors & Collaborators

  • The Leeds Teaching Hospitals NHS Trust

    lead OTHER

Eligibility

Min Age
60 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-10-31
Completion
2012-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02304068 on ClinicalTrials.gov