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
About this trial
This is an interventional trial for Acute Macular Degeneration
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
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
NCT ID
NCT02304068
First Posted
November 4, 2014
Last Updated
August 16, 2019
Sponsor
The Leeds Teaching Hospitals NHS Trust
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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