If you are possibly thinking about or have been approached to take part in a trial, there are a few key questions you should ask your Doctor or healthcare team:

1. What is the objective of the trial?
2. What (if any) treatment will you receive? And, how will it differ from your normal eye care?
3. Are there any possible side effects to taking part in the trial?

Interventional trials:

• Involves researchers actively testing a new treatment or intervention i.e. a drug or procedure, to see how it affects participants.
• In these trials, some people receive the treatment, while others might receive a placebo or standard care, so researchers can compare the results.

Observational trials:

• Involves researchers watching and collecting data without giving any specific treatment.
• They simply observe what happens in a group of people, over a set period of time, to learn about a condition or treatment already in use, without changing anything for the participants.

This will vary, depending on the aim of the trial.

• Some trials may require you to be given a new drug or procedure (interventional). 
• Others will require you to be more closely observed (observational). 

However, many trials will involve:

• Urine and / or blood samples
• Completing questionnaires
• Having specialist imaging of the eye
• Speaking to a researcher about their treatment and experiences during a trial

If you are interested in participating in, or have been invited to take part in a trial, you will be given a patient information sheet, that explains the trial and what taking part entails.

It ensures you fully understand what taking part in the trial means, before you consent to participate.

A member of the GREG Team will contact you to discuss and answer any initial questions you may have. 

Consent is usually obtained on your first physical visit to the GREG Centre, at Gloucester Royal Hospital. It involves you:

• Reviewing the patient information sheet
• Agreeing to participate in the trial
• Providing written confirmation of your agreement to participate, by signing a consent form

The GREG team will collect information from you as part of the trial. Your information will be held by the GREG team and any trial records or collected patient information will be kept confidential, in the same way as medical records. Anonymised data will be shared with the trial sponsors, for example a pharmaceutical company who’s drug is being used for the trial.

This varies, depending on the trial:

• Many last 1 or 2 years
• Some can be for as long 10 years

The length of the trial and how frequent your visits will be, are explained in the patient information sheets before you consent to taking part in the trial.

Yes, you can leave a trial at any time and do not have to give a reason.

If you leave a trial receiving treatment you will receive the standard treatment for your condition within the hospital eye service.