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Participant information

IRAS Project ID: 215114

Title of Study: The Bridlington eye assessment project (BEAP) Age-related Macular Degeneration (AMD) Study: Characterising Phenotype-Genotype Associations in a UK Population Cohort, and Response to Treatment for Neovascular AMD [BEAP-AMD2].

Population Study

Name of Researcher(s): Mr Winfried Amoaku and Professor Gregory Hageman

We would like to invite you to take part in our research study. Before you decide we would like you to understand why the research is being done and what it would involve for you. Talk to others about the study if you wish. 

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"Your contribution will help inform changing patterns of eye disease, especially age-related macular degeneration and how they interact with genes, in a rapidly ageing population, and guide future developments."

Winfried Amoaku
Associate Professor and Hon Consultant Ophthalmologist Academic Ophthalmology, University of Nottingham

1What is the purpose of the study?

Age-related macular degeneration (AMD) is the commonest cause of irreversible visual loss in the western world. This usually affects people older than 50 years old. In the UK approximately 500,000 people are affected by AMD. Around one in 2000 people have AMD at 60 years; however, it affects 1 in 10 at 80 years and 1 in 5 at 90 years. AMD occurs as a result from a combination of genetic make-up of individuals and environmental factors such as smoking and diet. Genetic differences in different people and populations may lead to varying differences in how AMD looks and progresses with time. The wet form of AMD is now treatable with injections of drugs called ‘anti-VEGFs’ including Eylea, Lucentis, but the dry type is not. We believe that an individual person’s response to treatments with these drugs may be influenced by their genes.

The purpose of our study is to find out how often AMD occurs in the UK, and how the different forms and stages of AMD progress in the UK population, and how they are related with the genes of individuals. We are also investigating how the individual person’s response to treatment with injections of ‘anti-VEGF’ drugs for wet AMD (in those persons already receiving treatment) is affected by their genes in a smaller study.

2Why have I been invited?

You are being invited to take part because you are resident in Bridlington, and are aged 60 years or older (and you may have different stages of AMD, other eye problems or no eye problems whatsoever), or you have been diagnosed as having wet AMD for which you are receiving treatment with ‘anti- VEGF’ injections into your eye in one of our selected hospitals. We are inviting 8,000 participants like you to take part who are aged 60 years and older and are resident in Bridlington.

In addition, a total of 600 patients treated with ‘anti-VEGF’ injections into the eye for wet AMD in Bridlington, York and King’s Mill Centre eye clinics will participate in the smaller study (described above).

3Do I have to take part?

It is up to you to decide whether or not to take part.  If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form, and complete a questionnaire about your health. If you decide to take part you are still free to withdraw at any time and without giving a reason. This would not affect your legal rights.

4What will happen to me if I take part?

If you agree to participate in this study, you will undergo one attendance to the research clinic that will last approximately one-half to two hours. Only one visit is required. We will explain to you in a small group as to what the research is about, and answer any questions you may have. You will then be seen individually from then to the end of your participation.

We will ask you to provide a DNA sample by swabbing the inside of your cheek. A member of our team will do this for you if you wish. You should not eat, drink, chew gum or smoke within 30 minutes before you arrive for your appointment as these activities will interfere with the swab results. At a future date (within the next 2 years), we may like to recall some participants who may show particular changes in their images and gene tests to return for blood specimens that will allow more detailed tests for clarification of our findings. Approximately 1-2 teaspoons of blood will be collected from you on that occasion, if you agree.

We will test your eyesight by asking you to read letter chart (similar to that used by opticians) whilst wearing your long distance or driving glasses. If you wear contact lenses, it is necessary to remove them before instilling drops in your eyes. It is therefore necessary for you to bring your distance glasses with you.

We will measure your eye pressure similar to what occurs at the optician or the hospital eye clinic, as well as the length of your eye.

We will take photographs of the back of your eyes after instilling dilating eye drops. Some of the time we can take these photographs without using any eye drops. However, most of the time, the photo quality is not adequate without eye drops. As such, for this research, you will have eye drops instilled in each eye in order to dilate your pupils in order to acquire a better quality image of the back of your eyes. The dilation may last for up to 2 hours so you will not be able to read or drive a car or that period of time and you should therefore refrain from driving to the research clinic.

We will request you to complete a health questionnaire on a tablet device or with the help of one of our researchers, or you may return it on paper, and contents transferred on to the tablet by one of our researchers, if you prefer. The questionnaire which will not have your name but unique study identification number, will take approximately 10 minutes to complete and includes questions about your medical history and current medications. You do not have to answer any particular questions you prefer not to.

At a future date (within the next 2 years), if you agree, we may like to recall some participants who may show particular changes in their images and gene tests to return for blood specimens that will allow more detailed tests for clarification of our findings. Approximately 1-2 teaspoons of blood will be collected from you on that occasion, if you agree.

If any other disease is detected during this study we will recommend follow-up examinations at your own doctor or local eye specialist, but these follow-up examinations are not considered part of the study. However, such a situation is uncommon as most participants attend regular eye tests at the optician who normally will look at the back of their eyes. Possible conditions that may be picked up include changes in the nerve at the back of the eye due to high pressure in the eye (called glaucoma), changes due to diabetes, and rarely a tumour at the back of the eye.

The genetic material (DNA) extracted will be extracted from the anonymised samples in Bridlington, and processed in the laboratory of Professor Gregory Hageman at the University of Utah, USA. The samples will be analysed for genetic changes that have been shown to be associated with increased risk for developing AMD.

5Expenses and payments

Participants will not be paid to participate in the study.

6What are the possible disadvantages and risks of taking part?

There are no potential risks of taking part, and there is no reason why you should come to any harm from this study. You may be inconvenienced by attending the research clinic, and especially if you have your pupils dilated. It is advised that you do not drive until the effects of the dilating drops have worn off, which may take up to 2 hours. Dilation of the pupil may give transient increased glare. Reading may also be affected for a short time. However, these is minimal, requiring no action normally. Occasionally, there may be unacceptable glare which may annoy you. A pair of dark glasses helps reduce the glare. If you are injured or become ill while taking part in this study, medical treatment is available from the local Hospitals.

7What are the possible benefits of taking part?

We cannot promise the study will help you but the information we get from this study may help others in the future. The main benefit is that doctors will have a better understanding of AMD and its progression, and outcomes of our current treatment of wet AMD, and how our genes affect these.

Even if there is no direct benefit to you as a result of your participation in this study, it is hoped that other people will benefit from this study by the knowledge that is gained about AMD and/or similar forms of macular degeneration as a result of this study.

8What happens when the research study stops?

All data generated from the study will be analysed to better understand AMD as explained above. Your ongoing healthcare will continue, as normal, and will not be interfered with.

9What if there is a problem?

If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions.  The researchers’ contact details are given at the end of this information sheet. If you remain unhappy and wish to complain formally, you can do this by contacting

in York/Bridlington,
Patient Advice and Liaison Service (PALS)
York Teaching Hospital NHS Foundation Trust
Wigginton Road
York
YO31 8HE
Tel. 01904 726262
Email: pals@york.nhs.uk
Or alternatively, the R&D Unit’s Research Adviser on 01904 725123

or

in Kings Mill Centre, Sutton in Ashfield
Patient Experience Team (PET)
Tel 01623 672222
Email: sfh-tr.pet@nhs.net

In the event that something does go wrong and you are harmed during the research and this is due to someone's negligence then you may have grounds for a legal action for compensation against the University of Nottingham but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you.

10Will my taking part in the study be kept confidential?

We will follow ethical and legal practice and all information about you will be handled in confidence.

If you join the study, we will use information collected from you [and your medical records] during the course of the research. This information will be kept strictly confidential, stored in a secure and locked office, and on a password protected database at the University of Nottingham, and University of Utah. Under UK Data Protection laws the University is the Data Controller (legally responsible for the data security) and the Chief Investigator of this study (named above) is the Data Custodian (manages access to the data). This means we are responsible for looking after your information and using it properly. Your rights to access, change or move your information are limited as we need to manage your information in specific ways to comply with certain laws and for the research to be reliable and accurate. To safeguard your rights we will use the minimum personally – identifiable information possible.

You can find out more about how we use your information and to read our privacy notice at:

https://www.nottingham.ac.uk/utilities/privacy.aspx.

The data collected for the study will be looked at and stored by authorised persons from the University of Nottingham who are organising the research, and University of Utah. They may also be looked at by authorised people from regulatory organisations to check that the study is being carried out correctly. All will have a duty of confidentiality to you as a research participant and we will do our best to meet this duty.

Where possible information about you which leaves the University of Nottingham will have your name and address removed and a unique code will be used so that you cannot be recognised from it, however sometimes we need to ensure that we can recognise you to link the research data with your medical records so in these instances we will need to know your name and date of birth. We will also need this information if we need to follow up your medical records as part of the research, where we may need to ask the Government services that hold medical information about you (such as NHS Digital, the Office for National Statistics, among others) to provide this information to us. By signing the consent form you agree to the above.

Your contact information will be kept by the University of Nottingham for 3 years after the end of the study so that we are able to contact you about the findings of the study and possible follow-up studies (unless you advise us that you do not wish to be contacted). This information will be kept separately from the research data collected and only those who need to will have access to it. All other data (research data) will be kept securely for 7 years. After this time your data will be disposed of securely. During this time all precautions will be taken by all those involved to maintain your confidentiality, only members of the research team given permission by the data custodian will have access to your personal data.

In accordance with the University of Nottingham’s, the Government’s and our funders’ policies we may share our research data with researchers in other Universities and organisations, including those in other countries, for research in health and social care. Sharing research data is important to allow peer scrutiny, re-use (and therefore avoiding duplication of research) and to understand the bigger picture in particular areas of research. Data sharing in this way is usually anonymised (so that you could not be identified) but if we need to share identifiable information we will seek your consent for this and ensure it is secure. Your data will be shared with members of our research group based in University of Utah under US laws. To help protect your confidentiality, information linking your identity with your medical and research information will be maintained in a protected database accessible only by Mr. Amoaku, Professor Hageman and a few of their staff members and colleagues.

Although what you say to us is confidential, should you disclose anything to us which we feel puts you or anyone else at any risk, we may feel it necessary to report this to the appropriate persons.

11What will happen if I don’t want to carry on with the study?

Your participation is voluntary and you are free to withdraw at any time, without giving any reason, and without your legal rights being affected. If you withdraw we will no longer collect any information about you or from you but we will keep the information about you that we have already obtained as we are not allowed to tamper with study records and this information may have already been used in some analyses and may still be used in the final study analyses. To safeguard your rights, we will use the minimum personally-identifiable information possible.

12Involvement of the general practitioner/family doctor (GP)

You will be asked about your general medical history. You will not receive any treatment as part of this study. Your GP will not be informed of your participation in this study. If we find anything that requires further investigation or treatment (as explained above), you will be referred appropriately to your GP or relevant specialist.

13What will happen to any samples I give?

We would also like to seek your consent so that any remaining DNA samples may be stored and used in possible future research on new genes that may be found to affect AMD in the future (which might not be known at present), and how they affect treatments – this is optional (please indicate you agree to this on the consent form). The anonymised data and samples will be stored with a code unique to you and securely at the University of Nottingham under the University’s Human Tissue Research Licence (no 12265) and the University of Utah.

No residual swab material will be retained, and will be destroyed in Bridlington. DNA samples will be stored indefinitely in the SCTM laboratories in Utah under the jurisdiction of US law.

Some of these future studies may be carried out by researchers other than current team of Mr Amoaku and Professor Hageman, who ran the first study, including researchers working for commercial companies. Any DNA samples or data used will be anonymised, and you will not be identified in anyway. If you do not agree to this any remaining samples will be disposed of in accordance with the Human Tissue Authority’s codes of practice.

14Will any genetic tests be done?

Yes. Analyses of the genetic material (DNA) extracted from the cheek swab samples will be performed. The samples will be analysed for genetic changes (DNA changes) associated with risk for developing AMD.

15What will happen to the results of the research study?

The results will be published in scientific and medical journals towards or at the end of the study. Copies of these publications will be available through the Chief Investigator – Mr Amoaku. If you have taken part in the study you will not be identified in any report/publication.

16Who is organising and funding the research?

This research is being organised by the University of Nottingham and is being funded by through a unrestricted (non-commercial and of no monetary value) research grants from Bayer and Boerhinger Ingelheim, as well as from internal funds of University of Nottingham and University of Utah.

17Who has reviewed the study?

All research in healthcare is looked at by independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by East Midlands – Nottingham 2 Research Ethics Committee.

18Further information and contact details

If you have any questions about the study please feel free to contact:

The Chief Investigator: Mr. Winfried Amoaku,
Associate Professor and Hon Consultant Ophthalmologist,
Academic Ophthalmology, University of Nottingham,
‘B’ Floor, Eye and ENT Centre,
University Hospital, Nottingham. NG7 2UH.
Email: Winfried.Amoaku@nottingham.ac.uk
Telephone number 01159249924 ext 62025.

And

Professor Gregory S Hageman,
Presidential Professor and Executive Director,
Sharon Eccles Steele Center for Translational Medicine (SCTM),
John A. Moran Eye Center, University of Utah,
Salt Lake City, USA. UT 84132
Tel: +1 801-213-2424
Email: gregory.hageman@hsc.utah.edu

For independent Advice, please contact
Professor H.S. Dua
Professor of Ophthalmology and Visual Sciences
Academic Ophthalmology, University of Nottingham,
‘B’ Floor, Eye and ENT Centre,
University Hospital, Nottingham. NG7 2UH.
Email: harminder.dua@nottingham.ac.uk
Telephone number 01159249924 ext 63757.