A community-based monitoring programme for the early detection of wet age-related macular degeneration
| ISRCTN | ISRCTN10005321 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10005321 |
| IRAS number | 331617 |
| Secondary identifying numbers | CPMS 60434, F. Hoffmann-La Roche Ltd Grant Code RE23_016_331617 |
- Submission date
- 23/10/2024
- Registration date
- 08/11/2024
- Last edited
- 04/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Wet age-related macular degeneration (wet AMD) is the leading cause of blindness in the UK. Affecting 40,000 new individuals every year, the prevalence is estimated to reach an average of 1.23 million people by 2050. The early detection of wet AMD in the second eye using optical coherence tomography (OCT) has been shown to result in better vision and quality of life. However, currently, there is no early detection system in place for the first eye. Due to the wide availability of OCT machines in the community, in high street optometry practices and diabetic screening programmes, this study aims to measure the adherence and acceptability of participants to a community-based monitoring program for the early detection of wet age-related macular degeneration.
Who can participate?
Anyone aged 50 years old and over with a diagnosis of dry age-related macular degeneration
What does the study involve?
Attending a community optometrist for an initial eye examination very similar to a standard eye test. If the participant is eligible, they will be randomised to one of two study arms, either attending again for a repeat examination after 12 months or attending more frequently to the community optometrist every 3 months for 12 months.
What are the possible benefits and risks of participating?
The potential benefit will be the early identification of wet age-related macular degeneration and referral to the NHS for treatment.
There are no possible risks for participating in the trial.
Where is the study run from?
Community-based optometrists based around York, Grimsby, Cleethorpes, Leeds and Teesside, UK
When is the study starting and how long is it expected to run for?
March 2024 to September 2026
Who is funding the study?
This study is funded by Roche via an investigator-initiated study grant.
Who is the main contact?
Prof Richard Gale, Richard.gale@york.ac.uk
Contact information
Scientific
Trial manager, Research Fellow in Ophthalmology at York and Scarborough Teaching Hospitals NHS Foundation Trust, and Honorary lecturer at Hull York Medical School at the University of York
York
YO318HE
United Kingdom
 ORCID ID |
0000-0002-2569-9810 |
|---|---|
| Rachel.hanson11@nhs.net |
Principal Investigator
Professor of Ophthalmology at Hull York Medical School, University of York, and Honorary Consultant medical ophthalmologist at York and Scarborough Teaching Hospital NHS Foundation Trust
York
YO103DD
United Kingdom
| ORCID ID |
0009-0006-0213-6253 |
|---|---|
| Richard.gale@york.ac.uk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Optician |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | early Detection Of neovascular age-Related mAcular Degeneration in the cOmmunity |
| Study acronym | DORADO |
| Study objectives | This study aims to assess the acceptability and adherence of participants who are at high risk of developing nAMD and practitioners to a community-based OCT monitoring program. |
| Ethics approval(s) |
Approved 20/03/2024, East of England-Cambridge Central Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 1048285; cambridgecentral.rec@hra.nhs.uk), ref: 24/EE/0009 |
| Health condition(s) or problem(s) studied | Specialty: Ophthalmology, Primary sub-specialty: Retina (including Diabetes); Health Category: Eye |
| Intervention | This is a randomised controlled trial assessing the differences between standard care and an OCT intervention program for monitoring early signs of neovascular age-related macular degeneration (nAMD). The target population will be participants diagnosed with dry AMD exhibiting OCT biomarkers associated with a higher risk for conversion to nAMD. Potential participants will be identified when they attend their routine clinical service in the community. The study will be advertised using posters in participating opticians, eye clinics and patient support groups for example. The trial will aim to recruit a minimum of 130 participants within 6 months, with a 12-month follow-up. To account for 30% withdrawal of consent, inconclusive imaging and missing data, the study aims to recruit a total of 169 participants. All participants will provide informed consent for their anonymised data to be used in this trial. Within the first 3 months of the recruitment period, the study will establish the feasibility of recruitment to the trial and will determine whether it can over-recruit to the trial during the remaining period. If not, the target of 130 participants will be recruited. An anticipated 6% of participants will be expected to convert to late-stage disease of which 3-4% will be nAMD. Participants should be managed as a part of standard care and referred as appropriate. Individuals attending their routine optometry or DRSS appointment will be approached about this trial if they meet the inclusion/exclusion criteria. Following a discussion about the trial and having been provided with the participant information sheet (PIS), potential participants have the option of consenting to the trial on the same day or at a later appointment. Following consent to join the trial, participants will complete the required baseline assessments and will be randomised 1:1 using the online service from SealedEnvelope.com to one of two trial arms: Arm 1 - Standard Care (SC): Participants will be advised to self-monitor changes in their vision using a provided AMSLER grid and to attend their opticians on a routine basis. Arm 2 - Intervention+ (OCT): Participants will follow an enhanced monitoring program, undergoing a visual acuity assessment, OCT and colour fundus photograph on a 3-monthly basis. Between the 3-monthly assessments, participants will also be advised to self-monitor changes in their vision using a provided AMSLER grid. Participants, or their nominated carer, will receive a reminder of their appointments. At the point of recruitment, all participants, regardless of the arm they are assigned, will undergo a visual acuity assessment, OCT and colour fundus examination. These same assessments will also be completed by all participants after 12 months. Only those participants in Arm 2 will repeat these same assessments on a 3-monthly basis. QoL and wellbeing questionnaires will be offered to the participants to complete either during this recruitment visit on site, to take home and complete with a self-addressed return envelope or to complete over the phone at a time convenient to them. Any incomplete questionnaire will be followed up with a phone call. At the 12-month follow-up, the same set of questionnaires will be completed by all participants along with an additional questionnaire assessing the acceptability of the monitoring program. All participants will be advised to self-monitor changes in their vision using an AMSLER grid and to contact their opticians for an assessment should they notice any changes or distortions, as per standard care practice. For any participant who attends an additional visit of this nature, a note should be made in the participant CRF, including the outcome and the date any referral to a treatment centre is made. During the course of the trial, any participant who converts to nAMD in either eye, therefore transferring to standard care via the NHS, will be asked to continue with the visits as part of the trial up to the end-of-study assessment at 12 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Participant acceptability is measured using the Theoretical Framework of Acceptability (TFA) questionnaire at 12 months 2. Attendance, adherence and persistence is measured using attendance data between baseline and 12 months 3. Changes in visual acuity are measured using ETDRS or Snellen scores between baseline and 12 months 4. Changes in quality-of-life and well-being are measured using the following questionnaires at baseline and 12 months: MacDQoL, NEI-VFQ-25, EQ-5D-3L, PHQ9 5. Acceptability of participating sites in conducting the monitoring programme will be measured using the Theoretical Framework of Acceptability (TFA) questionnaire at 12 months |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 06/03/2024 |
| Completion date | 19/09/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 130; UK Sample Size: 130 |
| Key inclusion criteria | 1. VA > 24 letters 2. Age > 50 years 3. OCT biomarkers: 3.1. Medium drusen with pigmentary abnormalities 3.2. Large drusen with or without pigmentary abnormalities 3.3. Subretinal drusenoid deposits (pseudo-reticular drusen) with or without pigmentary abnormalities 3.4. Geographic atrophy > 175µm, extrafoveal 3.5. Vitelliform lesions with visual acuity < 62 ETDRS letters (6/18) 3.6. Serous PED without neovascularisation |
| Key exclusion criteria | 1. Non-AMD macular degeneration, e.g., myopic degeneration, inherited macular dystrophy, MACTEL 2. Diabetic macular oedema 3. Macular haemorrhage of other causes, e.g., retinal vein occlusion 4. nAMD in both eyes 5. nAMD in one eye with the fellow eye under regular monitoring in secondary care 6. Intraretinal or subretinal haemorrhage 7. Inability to consent or comply with the trial visits 8. Inability to receive pupil dilation |
| Date of first enrolment | 06/06/2024 |
| Date of final enrolment | 30/04/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Huntington
York
YO32 9AF
United Kingdom
York
YO32 9AE
United Kingdom
Unit 3, 80 Albion Street
Leeds
LS1 6AD
United Kingdom
Grimsby
DN31 1DL
United Kingdom
Cleethorpes
DN35 8HL
United Kingdom
Trenchard Avenue
Thornaby
Stockton-on-tees
TS17 0EE
United Kingdom
Sponsor information
Hospital/treatment centre
Ron Cooke Hub, University of York campus East, Heslington
York
YO10 5GE
England
United Kingdom
| Phone | +44 (0)1904328693 |
|---|---|
| michael.barber@york.ac.uk | |
| Website | https://www.york.ac.uk |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
- Location
- Switzerland
Results and Publications
| Intention to publish date | 01/08/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
04/04/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 31/03/2025 to 30/04/2025.
2. The overall study end date was changed from 01/08/2026 to 19/09/2026.
23/10/2024: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
