Prediction of conversion to wet age-related macular degeneration (AMD)
| ISRCTN | ISRCTN13798759 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13798759 |
| IRAS number | 290536 |
| Secondary identifying numbers | CPMS 47988, IRAS 290536 |
- Submission date
- 22/03/2021
- Registration date
- 20/07/2021
- Last edited
- 30/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
Age-related macular degeneration (AMD) is a common condition that affects the middle part of your vision. It usually first affects people in their 50s and 60s. It doesn't cause total blindness. But it can make everyday activities like reading and recognising faces difficult. Without treatment, your vision may get worse. This can happen gradually over several years ("dry AMD"), or quickly over a few weeks or months ("wet AMD"). Patients with wet age-related macular degeneration (wAMD) in one eye are at risk of developing wAMD in the second "normal" eye (fellow eye) as well. This risk increases yearly and one of the factors among these is the presence of inactive wet AMD in the fellow eye (study eye). At present, there is not sufficient knowledge to inform patients how the presence of this inactive disease in the “normal eye" would affect the risk for conversion to wet AMD, which makes counselling patients and planning difficult.
Who can participate?
Patients aged 50 to 100 years old, with age-related macular degeneration.
What does the study involve?
This study will collect retinal images from scans and markers on these retinal image scans will be looked at. The risk of conversion in the "normal eye" to wet AMD will be calculated.
The study will be divided into 2 parts:
1. Prospective: Patients with a new diagnosis of wAMD and started on antiVEGF will consent for the prospective part of the study. Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (OCTA) will be used to image the study eye at a baseline visit and then at 1 and 2 years later to identify and study progress of Non-exudative Choroidal Neovascularization (neCNV) to predict increased risk of conversion of inactive wAMD to wAMD.
2. Retrospective: All patients who have started on antiVEGF treatment in one eye with wAMD in the last 12-15 months and the study eye that meet the inclusion and exclusion criteria will also be included in the study for retrospective data collection. Images from scans taken as per standard care will be collected for the study at baseline and year 1 and 2.
Patients will be in the study for 2 years.
What are the possible benefits and risks of participating?
This study will not benefit you directly. The outcome of this investigation will have no impact on the management of your condition. As we will perform analysis on retinal image scans from thousands of patients with age-related macular degeneration, the results will not be identifiable to a particular individual, hence we will not be able to provide feedback specific to you. However, by taking part in this study, you will be part of an effort to better understand wet age-related macular degeneration and the effect of its treatment, and help deliver novel tools to predict the disease onset and progression.
Where is the study run from?
Moorfields Eye Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2021 to January 2025
Who is funding the study?
Boehringer Ingelheim (UK)
Who is the main contact?
Prof. Sobha Sivaprasad, sobha.sivaprasad@nhs.net
Contact information
Scientific
Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
 ORCID ID |
0000-0001-8952-0659 |
|---|---|
| Phone | +44 (0)2075662109 |
| sobha.sivaprasad@nhs.net |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prevalence of subclinical Non-Exudative choroidal neovascularisation and its contribution to prediction of exudatiON in fellow eyes with unilateral exudative AMD (EYE-NEON) |
| Study acronym | EYE NEON |
| Study hypothesis | Age related macular degeneration is a leading cause of visual loss. Early detection and intervention of advanced neovascular AMD have been shown to improve visual outcomes. Once nAMD develops in one eye there is higher risk of subsequent development of choroidal neovascularization in the second eye. In a person with unilateral wAMD (exudative AMD), the risk of the contralateral or fellow eye also converting to wAMD is 10% per year from the time the first eye develops wAMD. However, not all patients convert in first year and so by 5 years, the risk of conversion is 50%. This makes it difficult to counsel patients of their risk as they can convert at anytime in the 5 years and sometimes even later. Better prediction tools are required. Numerous imaging related risk factors have been studied for conversion of to neovascular AMD in fellow eyes of patients with unilateral exudative AMD. There is sufficient evidence that subclinical non-exudative choroidal neovascularisation (subclinical CNV) detected by OCTA exist before the eyes convert to exudative AMD. The incidence and prevalence of subclinical CNV is unclear and whether it is the strongest predictor for conversion is also unclear. The prevalence of neCNV among patients with unilateral wAMD in the fellow eye have been variable, ranging from 6% to 27% based on OCT studies. Two-year follow-up data as assessed by OCT is sparse, but one study indicated a conversion of approximately 60% within two year. Current studies reporting data from OCT have been small and typically from single institutions. Furthermore, existing studies have not reported estimates by duration of fellow eye wAMD involvement. If neCNV is included in a risk model, we may be able to improve the time to conversion in fellow eye in the first 2 years. |
| Ethics approval(s) | Approved 25/01/2021, London - City & East Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; +44 (0)2071048370; cityandeast.rec@hra.nhs.uk), ref: 20/PR/0897 |
| Condition | Age-related macular degeneration |
| Intervention | This is a non-interventional cohort study and divided into a retrospective and prospective part. The retrospective part will collect retinal images that have been taken as part of routine clinical care - these will be taken at baseline and at year 1 and 2 if available. The prospective part will scan patients using OCT and OCTA at 3 different time points: baseline, year 1 and year 2. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Age, gender, ethnicity, smoking history, and date of anti-Vascular Endothelial Growth Factor injection of non-study eye measured using patient records at baseline 2. Visual acuity of study eye using ETDRS logs measured at baseline, month 12 and 24 3. Scans of the study eye using Optical Coherence Tomography measured at baseline, month 12 and 24 4. neCNV eyes converted to wAMD measured using Blue Auto Fluorescence and Optical Coherence Tomography Angiography measured at baseline, month 12 and 24 |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 15/01/2021 |
| Overall study end date | 01/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 800; UK Sample Size: 800 |
| Participant inclusion criteria | Consecutive patients at each site who meet the following inclusion and exclusion criteria: 1. Adults who are >=50 years and <=100 years 2. Fellow eyes of patients with unilateral treatment naïve neovascular AMD at baseline 3. Media clarity, pupillary dilation and patient cooperation for adequate imaging 4. Ability to give informed consent Inclusion criteria for retrospective part only in addition to above: 1. Fellow eyes of patients with unilateral neovascular AMD initiated on treatment in the past 12-15 months 2. Had OCT and OCTA for study eye at baseline |
| Participant exclusion criteria | 1. Treatment initiation for unilateral neovascular AMD more than 15 months prior to recruitment. 2. Late wet AMD in the study eye 3. Co-existent ocular disease: Any other ocular condition that, in the opinion of the investigator, might affect or alter visual acuity during the course of the study 4. Any patient who has opted out of their information being used for research nationally or locally at any site 5. Patients participating in a clinical trial with an ophthalmic experimental therapy will be excluded 6. Study eye (neCNV) is not treated with anti-VEGF within 6 months for non-wAMD reason |
| Recruitment start date | 20/04/2021 |
| Recruitment end date | 30/04/2023 |
Locations
Countries of recruitment
- England
- Northern Ireland
- United Kingdom
Study participating centres
London
EC1V 2PD
United Kingdom
Gorleston
Great Yarmouth
NR31 6LA
United Kingdom
Frimley
Camberley
GU16 7UJ
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
London
SE5 9RS
United Kingdom
Eastern Road
Brighton
BN2 5BE
United Kingdom
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Freeman Road
High Heaton
Newcastle
NE7 7DN
United Kingdom
York
YO31 8HE
United Kingdom
Leeds
LS9 7TF
United Kingdom
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Belfast
BT9 7AB
United Kingdom
Wolverhampton Road
Wolverhampton
WV10 0QP
United Kingdom
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
Praed Street
London
W2 1NY
United Kingdom
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Harlow
CM20 1QX
United Kingdom
Hardwick Lane
Bury St. Edmunds
IP33 2QZ
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
Sponsor information
Hospital/treatment centre
162 City Road
London
EC1V 2PD
England
United Kingdom
| Phone | +44 (0)2072533411 |
|---|---|
| moorfields.resadmin@nhs.net | |
| Website | http://www.moorfields.nhs.uk/ |
"ROR" |
https://ror.org/03zaddr67 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, BI, BIPI
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
30/04/2024: The following changes were made:
1. The overall study end date was changed from 01/04/2024 to 01/01/2025.
2. The intention to publish date was changed from 01/01/2025 to 01/06/2025.
22/03/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
