Proliferative Diabetic RetinopathyEMERALDNCT03490318
Effectiveness of Multimodal Imaging for the Evaluation of Retinal Oedema And New vesseLs in Diabetic Retinopathy
An observational study of Proliferative Diabetic Retinopathy and Diabetic Macular Edema, run by Belfast Health and Social Care Trust at 13 sites in United Kingdom.
Trial summary
Given the high number of people with DMO and PDR, the need for patients to be seen at short follow-up intervals, the need for frequent treatments and the requirement for long-term follow-up, there is a very large workload in Hospital Eye Services related to DMO/PDR which is making it difficult for the NHS to cope with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Proliferative Diabetic Retinopathy, Diabetic Macular Edema
- How many people
- 401 participants
- Where
- 13 sitesUnited Kingdom
- Study dates
- 26 Oct 2017to 23 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with type 1 or type 2 diabetes with previously successfully treated DMO and/or PDR and in whom, at the time of enrolment in the study, DMO and/or PDR may be active or inactive.
Who may be able to join
- Adults (18 years of age or older) with type 1 or 2 diabetes with previously successfully treated DMO and/or PDR in one or both eyes and in whom, at the time of enrolment in the study, DMO and/or PDR may be active or inactive.
- Active DMO will be defined as a central subfield retinal thickness (CRT) of > 300 microns and/or presence of intraretinal/subretinal fluid on spectral domain OCT.
- Inactive DMO will be defined as no intraretinal/subretinal fluid
- Active PDR will be defined by the presence of sub-hyaloid/vitreous haemorrhage and/or active new vessels (new vessels with lack of fibrosis on them)
- Inactive PDR will be defined by the lack of preretinal/vitreous haemorrhage and lack of active new vessels.
Who cannot join
- Unable to provide informed consent
- Patients do not read, speak or understand English
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United Kingdom13 sites
Royal Victoria Hospital
Belfast
Bradford Royal Infirmary
Bradford, BD9 6RJ
Bristol Eye Hospital
Bristol
Queen Margaret Hospital
Dunfermline, Scotland, KY12 0SU
Frimley Park Hospital
Frimley
Gloucestershire Royal Hospital
Gloucester, GL53 7AN
Moorfields eye Hospital
London, EC1V 2PD
King's College Hospital
London
Manchester Eye Hospital
Manchester
James Cook University Hopsital
Middlesbrough, North Yorkshire, TS4 3BW
Oxford John Radcliffe Hospital
Oxford
Sheffield Eye Hospital
Sheffield
City Hopsitals Sunderland
Sunderland
About this study
Given the high number of people with DMO and PDR, the need for patients to be seen at short follow-up intervals, the need for frequent treatments and the requirement for long-term follow-up, there is a very large workload in Hospital Eye Services related to DMO/PDR which is making it difficult for the NHS to cope with the demand, in particular, due to shortage of ophthalmologists. This is only expected to get worse given the increasing prevalence of DM. Identifying new ways of increasing the NHS capacity and efficiency without compromising the quality of care would greatly benefit the NHS.
The purpose of this study is to determine whether successfully treated patients with DMO and PDR could be followed up without a face-to-face examination by an ophthalmologist. EMERALD will evaluate a new care pathway which will include multimodal retinal imaging and separate image assessment by trained ophthalmic graders. This new pathway will be compared to the current standard care pathway: for DMO: ophthalmologist evaluating patients in clinic by slit-lamp biomicroscopy and with access to OCT images; for PDR ophthalmologists evaluating patients in clinic by slit-lamp biomicroscopy. EMERALD will compare how accurate the new pathway is at determining which patients have active or inactive disease. The costs and acceptability of current and new models of care will also be compared.
Read the detailed description
- Research Hypothesis The hypothesis is that the new form of surveillance for people with stable DMO and/or PDR will be as sensitive as the current standard of care but at a lower cost.
- Study Aim EMERALD aims to determine the diagnostic performance and cost-effectiveness of a new form of surveillance for people with stable DMO and/or PDR, using the current standard of care as the reference standard.
- Study Objectives
The specific objectives of this study are to evaluate the new surveillance pathway to:
- Quantify and compare the diagnostic accuracy (in terms of sensitivity, specificity, overall agreement, positive and negative likelihood ratios) of the new pathway of surveillance (ophthalmic grader pathway) using the current standard of care pathway as the reference standard. This will be done separately for DMO and PDR.
- Assess acceptability of the new surveillance pathway.
- Determine the proportion of patients requiring subsequent full clinical assessment by an ophthalmologist under the new pathway.
- Determine the proportion of patients unable to undergo imaging tests, with images of inadequate quality and indeterminate findings under the new pathway.
- Establish relative cost-effectiveness of the new surveillance pathway.
- Outcome measures
4.1 Primary outcome
The primary outcome measure is:
- Sensitivity of the new pathway (ophthalmic grader pathway) in detecting active DMO/PDR, using the standard care pathway as the reference standard.
4.2 Secondary outcomes
There are a number of secondary outcomes which will be measured and include:
- Specificity, concordance (agreement) between new pathway (ophthalmic grader pathway) and the standard care pathway, positive and negative likelihood ratios
- Cost-effectiveness
- Acceptability
- Proportion of patients requiring subsequent full clinical assessment
- Proportions of patients unable to undergo imaging, with inadequate quality images or indeterminate findings.
- STUDY DESIGN
5.1 Study Design
EMERALD is a prospective, cross-sectional diagnostic study of patients with diabetic retinopathy and DMO or PDR (or both) who had been previously successfully treated and who, at the time of enrolment in the study, may have active or inactive disease (both are required to evaluate the diagnostic performance of the new pathway).
Specifically, EMERALD will have a case-referent cross-sectional diagnostic study design with both sampling (selection) of patients and data collection carried out prospectively (18). This approach provides both a cost-efficient study design while also having a low risk of bias in terms of diagnostic accuracy (19)
5.2 Study Setting
Specialist Hospital Eye Services (HES) in the UK. All centres involved have extensive experience with the management of patients with diabetic retinopathy, DMO and PDR.
- End of Study
For the purposes of submitting the end of trial notification to the Sponsor and the Research Ethics Committee (REC), the end of trial will be considered to be when the database lock occurs for the final analysis. The trial will be stopped prematurely if:
- Mandated by the REC
- Mandated by the Sponsor (e.g. following recommendations from the Trial Steering Committee (TSC)
- Funding for the trial ceases The REC that originally gave a favourable opinion of the trial will be notified in writing when the trial has been concluded or if it is terminated early.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with DMO and/or PDR | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the new pathway (ophthalmic grader pathway) in detecting active DMO/PDR, using the standard care pathway as the reference standard.
Sensitivity analysis
Measured: 30 months
Secondary outcomes (5)
Specificity, concordance (agreement) between new pathway (ophthalmic grader pathway) and the standard care pathway, positive and negative likelihood ratios
specificity, concordance, positive and negative likelihood ratios
Measured: 30 months
Cost-effectiveness
specificity analysis, QALY
Measured: 30 months
Acceptability
specificity, concordance, positive and negative likelihood ratios
Measured: 30 months
Proportion of patients requiring subsequent full clinical assessment
specificity, concordance, positive and negative likelihood ratios
Measured: 30 months
Proportions of patients unable to undergo imaging, with inadequate quality images or indeterminate findings.
specificity, concordance, positive and negative likelihood ratios
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start26 Oct 2017
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Noemi Lois, PhD, FRCS(Ed). FRCOphth., Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490318
- Sponsor's protocol ID
- 17020NL-AS
- Other IDs
- 10856638, 17/NI/0124
- Acronym
- EMERALD
- Status last verified
- Feb 2022
- First submitted
- 5 Dec 2017
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 15.4 Data Sharing Statement Requests for data sharing will be reviewed on a case by case basis by the CI and TMG. 15.5 Data Access Following the publication of the primary and secondary outcomes, there may be scope to conduct additional analyses on the data collected. In such instances, formal requests for data will need to be made in writing to the CI who will discuss this with the TMG. In the event of publications arising from such analyses, those responsible will need to provide the CI with a copy of any intended manuscript for approval prior to submission. Authorship will need to take the format of "\[name\] on behalf of the EMERALD Clinical Trial Group" or something similar, which will be agreed by the TMG.
Publications
Maredza M, Mistry H, Lois N, Aldington S, Waugh N; EMERALD Study Group. Surveillance of people with previously successfully treated diabetic macular oedema and proliferative diabetic retinopathy by trained ophthalmic graders: cost analysis from the EMERALD study. Br J Ophthalmol. 2022 Nov;106(11):1549-1554. doi: 10.1136/bjophthalmol-2021-318816. Epub 2021 Jun 3.
PubMed 34083209Lois N, Cook J, Wang A, Aldington S, Mistry H, Maredza M, McAuley D, Aslam T, Bailey C, Chong V, Ghanchi F, Scanlon P, Sivaprasad S, Steel D, Styles C, Azuara-Blanco A, Prior L, Waugh N. Multimodal imaging interpreted by graders to detect re-activation of diabetic eye disease in previously treated patients: the EMERALD diagnostic accuracy study. Health Technol Assess. 2021 May;25(32):1-104. doi: 10.3310/hta25320.
PubMed 34060440Lois N, Cook J, Aldington S, Waugh N, Mistry H, Sones W, McAuley D, Aslam T, Bailey C, Chong V, Ghanchi F, Scanlon P, Sivaprasad S, Steel D, Styles C, McNally C, Rice R, Prior L, Azuara-Blanco A; EMERALD Study Group. Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy (EMERALD). BMJ Open. 2019 Jun 28;9(6):e027795. doi: 10.1136/bmjopen-2018-027795.
PubMed 31256030
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Multimodal Imaging for the Evaluation of Retinal Oedema And New vesseLs in Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT03490318
- Acronym / sponsor ID
- EMERALD / 17020NL-AS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Given the high number of people with DMO and PDR, the need for patients to be seen at short follow-up intervals, the need for frequent treatments and the requirement for long-term follow-up, there is a very large workload in Hospital Eye Services related to DMO/PDR which is making it difficult for the NHS to cope with the demand, in particular, due to shortage of ophthalmologists. This is only expected to get worse given the increasing prevalence of DM. Identifying new ways of increasing the NHS capacity and efficiency without compromising the quality of care would greatly benefit the NHS.
The purpose of this study is to determine whether successfully treated patients with DMO and PDR could be followed up without a face-to-face examination by an ophthalmologist. EMERALD will evaluate a new care pathway which will include multimodal retinal imaging and separate image assessment by trained ophthalmic graders. This new pathway will be compared to the current standard care pathway: for DMO: ophthalmologist evaluating patients in clinic by slit-lamp biomicroscopy and with access to OCT images; for PDR ophthalmologists evaluating patients in clinic by slit-lamp biomicroscopy. EMERALD will compare how accurate the new pathway is at determining which patients have active or inactive disease. The costs and acceptability of current and new models of care will also be compared.
Detailed description
- Research Hypothesis The hypothesis is that the new form of surveillance for people with stable DMO and/or PDR will be as sensitive as the current standard of care but at a lower cost.
- Study Aim EMERALD aims to determine the diagnostic performance and cost-effectiveness of a new form of surveillance for people with stable DMO and/or PDR, using the current standard of care as the reference standard.
- Study Objectives
The specific objectives of this study are to evaluate the new surveillance pathway to:
- Quantify and compare the diagnostic accuracy (in terms of sensitivity, specificity, overall agreement, positive and negative likelihood ratios) of the new pathway of surveillance (ophthalmic grader pathway) using the current standard of care pathway as the reference standard. This will be done separately for DMO and PDR.
- Assess acceptability of the new surveillance pathway.
- Determine the proportion of patients requiring subsequent full clinical assessment by an ophthalmologist under the new pathway.
- Determine the proportion of patients unable to undergo imaging tests, with images of inadequate quality and indeterminate findings under the new pathway.
- Establish relative cost-effectiveness of the new surveillance pathway.
- Outcome measures
4.1 Primary outcome
The primary outcome measure is:
- Sensitivity of the new pathway (ophthalmic grader pathway) in detecting active DMO/PDR, using the standard care pathway as the reference standard.
4.2 Secondary outcomes
There are a number of secondary outcomes which will be measured and include:
- Specificity, concordance (agreement) between new pathway (ophthalmic grader pathway) and the standard care pathway, positive and negative likelihood ratios
- Cost-effectiveness
- Acceptability
- Proportion of patients requiring subsequent full clinical assessment
- Proportions of patients unable to undergo imaging, with inadequate quality images or indeterminate findings.
- STUDY DESIGN
5.1 Study Design
EMERALD is a prospective, cross-sectional diagnostic study of patients with diabetic retinopathy and DMO or PDR (or both) who had been previously successfully treated and who, at the time of enrolment in the study, may have active or inactive disease (both are required to evaluate the diagnostic performance of the new pathway).
Specifically, EMERALD will have a case-referent cross-sectional diagnostic study design with both sampling (selection) of patients and data collection carried out prospectively (18). This approach provides both a cost-efficient study design while also having a low risk of bias in terms of diagnostic accuracy (19)
5.2 Study Setting
Specialist Hospital Eye Services (HES) in the UK. All centres involved have extensive experience with the management of patients with diabetic retinopathy, DMO and PDR.
- End of Study
For the purposes of submitting the end of trial notification to the Sponsor and the Research Ethics Committee (REC), the end of trial will be considered to be when the database lock occurs for the final analysis. The trial will be stopped prematurely if:
- Mandated by the REC
- Mandated by the Sponsor (e.g. following recommendations from the Trial Steering Committee (TSC)
- Funding for the trial ceases The REC that originally gave a favourable opinion of the trial will be notified in writing when the trial has been concluded or if it is terminated early.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with DMO and/or PDR | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with type 1 or type 2 diabetes with previously successfully treated DMO and/or PDR and in whom, at the time of enrolment in the study, DMO and/or PDR may be active or inactive.
Key inclusion criteria (5 listed)
- Adults (18 years of age or older) with type 1 or 2 diabetes with previously successfully treated DMO and/or PDR in one or both eyes and in whom, at the time of enrolment in the study, DMO and/or PDR may be active or inactive.
- Active DMO will be defined as a central subfield retinal thickness (CRT) of > 300 microns and/or presence of intraretinal/subretinal fluid on spectral domain OCT.
- Inactive DMO will be defined as no intraretinal/subretinal fluid
- Active PDR will be defined by the presence of sub-hyaloid/vitreous haemorrhage and/or active new vessels (new vessels with lack of fibrosis on them)
- Inactive PDR will be defined by the lack of preretinal/vitreous haemorrhage and lack of active new vessels.
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Patients do not read, speak or understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of the new pathway (ophthalmic grader pathway) in detecting active DMO/PDR, using the standard care pathway as the reference standard.
Time frame: 30 months
Sensitivity analysis
5 secondary outcomes
Specificity, concordance (agreement) between new pathway (ophthalmic grader pathway) and the standard care pathway, positive and negative likelihood ratios
Time frame: 30 months
Cost-effectiveness
Time frame: 30 months
Acceptability
Time frame: 30 months
Proportion of patients requiring subsequent full clinical assessment
Time frame: 30 months
Proportions of patients unable to undergo imaging, with inadequate quality images or indeterminate findings.
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Derived from this study: PubMed 34083209Maredza M, Mistry H, Lois N, Aldington S, Waugh N; EMERALD Study Group. Surveillance of people with previously successfully treated diabetic macular oedema and proliferative diabetic retinopathy by trained ophthalmic graders: cost analysis from the EMERALD study. Br J Ophthalmol. 2022 Nov;106(11):1549-1554. doi: 10.1136/bjophthalmol-2021-318816. Epub 2021 Jun 3.
- Derived from this study: PubMed 34060440Lois N, Cook J, Wang A, Aldington S, Mistry H, Maredza M, McAuley D, Aslam T, Bailey C, Chong V, Ghanchi F, Scanlon P, Sivaprasad S, Steel D, Styles C, Azuara-Blanco A, Prior L, Waugh N. Multimodal imaging interpreted by graders to detect re-activation of diabetic eye disease in previously treated patients: the EMERALD diagnostic accuracy study. Health Technol Assess. 2021 May;25(32):1-104. doi: 10.3310/hta25320.
- Derived from this study: PubMed 31256030Lois N, Cook J, Aldington S, Waugh N, Mistry H, Sones W, McAuley D, Aslam T, Bailey C, Chong V, Ghanchi F, Scanlon P, Sivaprasad S, Steel D, Styles C, McNally C, Rice R, Prior L, Azuara-Blanco A; EMERALD Study Group. Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy (EMERALD). BMJ Open. 2019 Jun 28;9(6):e027795. doi: 10.1136/bmjopen-2018-027795.
- Individual participant dataSharing planned: Undecided. 15.4 Data Sharing Statement Requests for data sharing will be reviewed on a case by case basis by the CI and TMG. 15.5 Data Access Following the publication of the primary and secondary outcomes, there may be scope to conduct additional analyses on the data collected. In such instances, formal requests for data will need to be made in writing to the CI who will discuss this with the TMG. In the event of publications arising from such analyses, those responsible will need to provide the CI with a copy of any intended manuscript for approval prior to submission. Authorship will need to take the format of "[name] on behalf of the EMERALD Clinical Trial Group" or something similar, which will be agreed by the TMG.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noemi Lois, PhD, FRCS(Ed). FRCOphth. principal investigator
Queen's University, Belfast
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proliferative Diabetic Retinopathy and Diabetic Macular Edema, run by Belfast Health and Social Care Trust at 13 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the new pathway (ophthalmic grader pathway) in detecting active DMO/PDR, using the standard care pathway as the reference standard. (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03490318, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.