CERA

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Survey: Your thoughts on gene therapy for inherited retinal diseases

The Centre for Eye Research Australia invites people living with inherited retinal diseases and their parents/guardians to share their views and opinions about new potential gene therapy treatments.

For the thousands of Australians living with inherited retinal diseases, there has so far been little that could be done to slow down progressive vision loss.
But there are exciting new possibilities on the horizon. In fact, the first gene therapy treatments for inherited retinal diseases are expected to be available in Australia within the next few months.

To help researchers understand how we can support people in navigating information about possible gene therapy treatments, we’d like to invite anyone who is living in Australia with an inherited retinal disease to participate in this questionnaire.

We are also seeking input from the parents or guardians of children with an inherited retinal disease.

By answering these questions, you will share with us your lived experience and your views and opinions about upcoming gene therapy treatments.

This information will not only help us understand your unique perspective, but will also help us ensure people are well informed about emerging gene therapy treatments.

To take part in this survey, please first read the information below.

Plain Language Statement for Participants


Overview

Project title: Survey of potential participant perspective on ocular gene therapy in Australia

Researchers: A/Prof Heather Mack (principal investigator), Dr Lauren Ayton (responsible investigator), A/Prof Fred Chen, A/Prof John Grigg, Dr Thomas Edwards, Ms Fleur O’Hare, Ms Ceecee Zhang, Prof Keith Martin.

Contact email: [email protected]

Why is the study being conducted?

We are conducting research into the knowledge of Australian people with inherited retinal disease (IRD) regarding gene therapy for their condition.

There has been a lot of progress in the field, and an Australian government approved treatment will be released shortly (Luxturna™ treatment for RPE65 retinal dystrophy), and we are interested to understand your knowledge of these treatments.

What do I need to do?

As part of this study, you are invited to complete a survey (either on paper or online). The questions ask about how your condition has impacted your lifestyle, what you know about clinical trials in general, and what you know about government approved gene therapy to be released shortly. The survey will take about one hour to complete.

At the end of the survey you will be asked if you want to be contacted for more information on IRD genetic testing; if you want to receive a lay person summary of the report findings; and if you are happy for your responses and your contact details to be stored for possible future closely related studies.

Your participation is entirely voluntary.

How will be participants be selected?

Participants will be people with inherited retinal disease (IRD) who are Australian residents and English speaking, and/or their parents/guardians.

We will include people from a range of backgrounds and experiences, and therefore you will be asked to provide details of your condition and any previous experience with treatments.

Your personal details will remain confidential at all times.

At the end of the survey, you have the option to list your contact details so that we can contact you with further information, or for future studies. This contact information will not be shared with others and will only be accessible to the named investigators of this study.

How will this research be used to benefit the community?

The survey results will assist us understanding how people with inherited retinal disease view gene treatment of their condition and may inform future clinical trials of treatment for inherited retinal disease.

What are the risks?

There are no anticipated risks in taking part. The questions asked will not contain sensitive information. However, if you experience any distress from participation, please contact your GP for professional guidance and advice.

Our research team are also available to discuss any concerns that you may have, or feelings of distress from the questions – you can contact us via email ([email protected]).

Additional resources are available if you do experience distress, including:

  • Lifeline 24 hour counselling – 131114
  • Lifeline Victoria Suicide 24 Hour helpline – 1300 651 251
  • Beyond Blue – 1300 224 636
  • Veterans Counselling Service – 1800 011 046
  • Royal Victorian Eye and Ear Hospital consumer liaison officer – 03 9929 8666
  • Sydney Eye Hospital patient liaison officer – 02 9382 7111
  • Retina Australia – 1800 999 870
  • Vision Australia – 1300 847 466

Am I free to withdraw?

Participation in this study is completely voluntary and you may withdraw at any time with no risk of negative consequences.

If you choose to not participate this will not affect your relationship with your ophthalmologist or patient support group, or access to any future treatment that may become available for you.

If you choose to withdraw your participation in this study, we will not be able to remove your data (as it is de-identified). However, if you have provided us with your personal details for further contact, we can remove that from our database.

You may be in a doctor-patient relationship with one or more of the researchers listed in this study. It is important that you are aware that this potential conflict of interest will be managed in the following ways:

  • Your doctor will not know the answers you provide to the survey.
  • Your doctor will not know whether or not you participate in the study.
  • Your participation, or decision not to participate, will not affect your relationship with your doctor, or your medical care.

How do I express consent?

Your consent will be obtained in different ways, depending in whether you complete this survey online or in a hard copy paper form.

  • If online, you will be asked to tick a box to confirm that you have read this information and are happy to be involved in the study.
  • If in a hard copy form, you will sign the consent form that accompanies this statement. You will return one copy to the researchers, and be provided with a copy for your own records.

How will my confidentiality be protected?

Your contribution to the survey will be collected and data will be stored in a secured location at the Centre for Eye Research Australia for a period of fifteen years.

All participants’ personal details will be confidential. All data will be anonymized (including names, locations and conditions) and you will not be identifiable within any publications made as a result of this study.

If you provide us with your contact details at the end of the survey, we will contact you for the reasons you have selected (receiving a summary of the study findings and/or finding out more information about genetic testing in IRD).

Will participating cost me anything?

No, participating in the study is completely free of charge.

Will I be reimbursed for my time?

No, you are participating voluntarily to improve researchers’ understanding of your knowledge regarding treatments for your condition. You will not receive any payments, incentives or reimbursements for your participation.

Dissemination of results

We intend to publish the results of this study. If you indicate at the end of the survey, and leave your email address, you will receive a de-identified copy of the aggregated results at the completion of the study (anticipated in 2022).

These reports of deidentified aggregated results will also be provided to patient support groups which have assisted in participant recruitment. Study results will be disseminated to the scientific community through scientific publications in peer-reviewed journals and presentations in relevant national and international conferences.

Ethics approval

This research project has been approved by the Human Research Ethics Committee of The University of Melbourne (project ID 2057534.2).

If you have any concerns or complaints about the conduct of this research project, which you do not wish to discuss with the research team, you should contact the Manager, Human Research Ethics, Research Ethics and Integrity, University of Melbourne, VIC 3010. Tel: +61 3 8344 2073 or email: [email protected]. All complaints will be treated confidentially.

In any correspondence please provide the name of the research team or the name or ethics ID number of the research project.

Research funding

This project is being funded by the investigators, with no financial involvement from pharmaceutical companies. The project is supported in part by a 2021 research grant from Retina Australia to Drs Mack, Grigg, Chen and Ayton.

What happens now?

If you would like to participate, you can choose to complete the survey online or on a hard copy paper form.

If you would prefer a hard copy form, and have not already received one, please contact:

Ms Ceecee Zhang, Study Coordinator

Email: [email protected]

Phone: (03) 9929 8621

Please also contact the researchers on the above details if you have low vision and want to dictate your answers to a researcher who will enter the data on your behalf.

Take the survey online

If you would like to take the survey online, please click through to begin. The survey will take around one hour to complete.

Note: Some users have reported difficulties using the survey form with older versions of JAWS. If you are experiencing difficulties, please use NVDA. Download from this site: NVDA.

 

What if I want more information about the study?

For additional information about the project, please contact Heather Mack at [email protected]