Acute Macular Degeneration Clinical Trial
Official title:
The Accuracy of Home Monitoring for Disease Activity During Maintenance Therapy for Neovascular Age-related Macular Degeneration
| Verified date | August 2019 |
| Source | The Leeds Teaching Hospitals NHS Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | October 2012 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 60 Years to 99 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| The Leeds Teaching Hospitals NHS Trust |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Monitor disease activity at home using near reading chart | The reproducibility of the home monitoring assessment exercise | 7 months |