Condition category
Eye Diseases
Date applied
23/10/2017
Date assigned
25/10/2017
Last edited
25/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Wet age-related macular degeneration (AMD) is the commonest cause of blindness in the UK. Providing prompt access to clinics for regular surveillance and treatment has proved a major challenge for the NHS. Most patients need a series of injections followed by a period of regular check-ups in case more injections are required. Wet AMD can often flare up after a period when treatment has not been required and check-ups are usually needed for several years. Vision tests completed by patients themselves at home (home monitoring tests) to detect the need for treatment could mean that patients would not need regular hospital check-ups, allowing clinic appointments to be kept for patients likely to require treatment. Home monitoring would be more convenient and less costly for both the patient and the NHS. The main aim of this study is to find out whether three home monitoring tests can detect when wet AMD needs to be treated as well as the tests currently carried out at hospital check-ups. The home monitoring tests are a paper booklet and two vision test software applications (MultiBit test and MyVisionTrack®) that run on an iPod touch.

Who can participate?
Patients aged 50 and over with AMD

What does the study involve?
Participants are asked to perform the home monitoring tests weekly at home in between their standard hospital check-ups over a period of 1 to 2 years. All equipment is provided and every other aspect of care stays the same. The home monitoring test results are not known by the patients' hospital care teams. The results are compared with the ophthalmologist’s diagnosis at routine hospital check-ups, made on the basis of clinical examination and the results of hospital-based tests. The acceptability of home monitoring to both participants and their carers is assessed at three of the five hospitals by interviewing a sample of participants and carers in their homes and by telephone or Skype.

What are the possible benefits and risks of participating?
The results from this study may help to improve the care for other people diagnosed with AMD in the future. This is because home eye testing might be more convenient as patients might not need so many regular hospital check-ups. There are no known safety issues or risks with taking part in home eye testing. The only potential disadvantage is the time taken and potential inconvenience of completing the tests. The possible disadvantages are also being investigated as part of the study.

Where is the study run from?
1. James Paget University Hospitals Foundation NHS Trust (UK)
2. University Hospital Southampton Foundation NHS Trust (UK)
3. Royal Liverpool & Broadgreen University Hospitals NHS Trust (UK)
4. Belfast Health and Social Care Trust (UK)
5. Moorfields Eye Hospital NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
October 2017 to March 2021

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
Prof. Barney Reeves
Barney.Reeves@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Barney Reeves

ORCID ID

Contact details

CTEU Bristol
Level 7 Queens Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 34 23143
Barney.Reeves@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 15/97/02

Study information

Scientific title

Monitoring for neovascular AMD reactivation at home: the MONARCH study

Acronym

MONARCH

Study hypothesis

Self-monitoring vision tests performed by patients with neovascular age-related macular degeneration (AMD) at home (called "home monitoring tests") can detect occurrence and reactivation of disease with comparable accuracy to tests currently performed by hospital eye services. An integrated qualitative study is also taking place focusing on the acceptability of home-monitoring vision tests.

More details can be found at: https://www.journalslibrary.nihr.ac.uk/programmes/hta/159702/#/

Ethics approval

Northern Ireland REC-A - submission pending

Study design

Diagnostic test-accuracy study with integrated qualitative component

Primary study design

Observational

Secondary study design

Diagnostic test-accuracy study

Trial setting

Home

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Age-related macular degeneration (AMD) and neovascular age-related macular degeneration (nAMD)

Intervention

This study will evaluate three self monitoring vision tests; a paper booklet and two vision test software applications (MultiBit test and MyVisionTrack®) that run on an iPod touch.

Approximately ≥400 participants will be recruited from 5 hospitals who will be asked to perform the home monitoring tests weekly at home in between their standard hospital check-ups over a period of 1 to 2 years. All participants will be asked and expected to complete all three home monitoring tests weekly for both eyes (so long as they have “useful” vision in both eyes). All equipment will be provided and every other aspect of care will stay the same. The home monitoring test results will not be known by patient's hospital care teams.

The objective is to estimate the test accuracy of the three tests (index tests) to self-monitor reactivation of nAMD, compared to the reference standard of the reviewing ophthalmologist’s decision at a routine hospital check-up with Optical Coherence Tomography (OCT) imaging, clinical examination and Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity. Participants will complete home monitoring tests and routine hospital follow-up for at least 12 months (from consent until the end of study). They will be seen in hospital according to the recruiting hospital’s standard follow-up protocol.

The outcomes of the two tests will then be compared with one another in order to evaluate the accuracy of the index test(s). The study design is cross-sectional, and involves all patients suspected of having the condition of interest (activate AMD) undergoing the index test and the reference test. Those who test positive for the condition by the reference test can be considered to be the cases, whereas those who test negative are the controls.

The acceptability of home monitoring to both participants and their carers will also be investigated at 3 of the 5 hospitals. A sample of participants and carers will be interviewed in their homes and by telephone or Skype.

Intervention type

Device

Phase

Drug names

Primary outcome measure

The primary outcome is classification of a study eye at a visit as having active or inactive disease. For the reference classification, this is the reviewing ophthalmologist’s decision at a monitoring visit about the activity status of the eye being monitored (definitely active, definitely inactive, ambiguous). Data will also be collected on whether an injection is ordered/given, though this may not correlate perfectly with classification by lesion activity as (a) a patient may decide to refuse further injections or a patient’s health may preclude it or (b) an injection may be given when a lesion is inactive, e.g. in the context of a treat-and-extend regimen. For the index texts, alternative criteria for classification will be explored to maximise test performance. Participants will complete home monitoring tests and routine hospital follow-up for at least 12 months (from consent until the end of study).

Secondary outcome measures

1. The acceptability of the tests to patients and carers and their adherence to home monitoring testing regimens, measured using interviews in their homes and by telephone or Skype
2. Inequalities in recruitment to the study (e.g. age, sex, social economic status and visual acuity in the better-seeing eye at diagnosis) and their impact on the ability of participants to do the tests during follow-up and the adherence of participants to weekly testing

Overall trial start date

01/10/2017

Overall trial end date

01/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients ≥ 50 years old diagnosed with active nAMD (≥ 6 months earlier) and currently being treated with an anti-VEGF drug or monitored (i.e. with active or inactive nAMD) by the NHS
2. Within 42 months of first treatment for nAMD

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

>=400

Participant exclusion criteria

1. Vision in the eye being monitored limited by another eye condition
2. Surgery in the study eye in the previous 6 months
3. Refractive error in the eye being monitored >-6D
4. Retinal or choroidal neovascularization in the eye being monitored not due to nAMD
5. Inability to do one or more of the proposed tests as assessed during ‘further information and training’ session
6. Unable to understand English
7. Unable to comply with proposed home testing

Recruitment start date

01/03/2018

Recruitment end date

30/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

James Paget University Hospitals Foundation NHS Trust
NR31 6LA

Trial participating centre

University Hospital Southampton Foundation NHS Trust
SO16 6YD

Trial participating centre

Royal Liverpool & Broadgreen University Hospitals NHS Trust
L7 8XP

Trial participating centre

Belfast Health and Social Care Trust
BT9 7AB

Trial participating centre

Moorfields Eye Hospital NHS Foundation Trust
EC1V 2PD

Sponsor information

Organisation

The Queen's University Belfast

Sponsor details

Research Governance
Ethics and Integrity
Queen’s University Belfast
University Road
Belfast
BT7 1NN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The protocol will be uploaded to the HTA website: https://www.journalslibrary.nihr.ac.uk/programmes/hta/159702/#/summary-of-research

The findings will be disseminated by usual academic channels, i.e. presentation at international meetings, as well as by peer-reviewed publications and through patient organisations and newsletters to patients, where available. The trialists intend to submit a manuscript for publication in March 2021.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/03/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes