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Study Details

This section aims to provide an overview of the STAR Study. It contains information that should help you decide whether or not you are interested in taking part. If you would like further information, including a copy of the official patient information leaflet, please contact your local hospital taking part in the study. Alternatively you can contact the base hospital, King's College Hospital (London), and we can send you the information sheet directly.

Study Overview & SRT Study Design

Study Overview and SRT

What is the purpose of the STAR Study?

The STAR Study investigates how effective and safe stereotactic radiotherapy (SRT) is as a treatment for wet age-related macular generation (wet AMD), when used in combination with a drug known as Lucentis® (also known as ranibizumab).

Normally, injections of drugs such as Lucentis have to be given up to monthly into the eye for several years. This study is testing if the combination treatment will reduce the number of treatments of Lucentis® that patients need. To determine the effectiveness of SRT, it will be compared to Lucentis injections on their own.

What is SRT and why are we using it to treat wet AMD?

SRT uses a device manufactured by Oraya, and therefore SRT is sometimes referred to as Oraya therapy.

The SRT device delivers a highly focused narrow beam of X-rays to the eye, which aims to prevent the growth of abnormal blood vessels that are responsible for the leakage of fluid and bleeding that occurs in wet AMD. SRT can be combined with eye injections that are similar to, or the same as, those you are already receiving (such as Lucentis®, Avastin® or Eylea®). Based on research to date, we think that this combined approach will reduce the need for such regular eye injections.

What does SRT involve and is it safe?

The SRT device delivers a dose of radiation from outside the eye, and therefore means no surgery is required. The treatment is completed in approximately 15 to 30 minutes while sitting in a chair, and is performed on an outpatient basis. After treatment you can go home after the appropriate checks have been made. SRT is required only once.

The SRT device will deliver a 16 Gray dose of radiation to your eye. This dose of radiation is similar to that received during a dental X-ray, or the amount of radiation you absorb naturally over 3 months, as part of everyday life. The aim of radiotherapy, such as SRT, is to kill off the actively growing, abnormal blood vessels that cause wet AMD, but there may be a risk of damage to healthy cells. Collateral damage to healthy vessels leads to loss of vision in about 1% of people treated with SRT. If you wish to find out more please request the full patient information sheet, which details the risks and benefits of SRT in more detail.

The SRT system has a CE mark, meaning it is licensed for use in the eye and is no longer classified as an experimental device, but it is a newer treatment than anti-VEGF injections (such as Lucentis®, Avastin® or Eylea®), which have been used in larger number of patients over a longer period (approximately 7 years).

If you have any more questions about SRT please speak to one of the research team at your local hospital or the retinal research team at King's College Hospital, London.

Study Design

How is the study designed?

The STAR Study is a randomised, double-masked clinical trial. This means that participants are randomly allocated to different treatment groups (like flipping a coin), and neither the participant or the team of researchers, including your doctor, know what group you are in. This a commonly used design, and is very powerful as it prevents any bias or favouritism to any particular treatment group.

What does being a participant in the study involve?

Should you decide to participate in the STAR Study, you will be assigned at random to one of the following two treatment groups:

  • One SRT treatment immediately followed by a Lucentis® injection
  • One "sham" treatment (no SRT) immediately followed by a Lucentis® injection

The likelihood of receiving “sham” treatment is less than the likelihood of receiving active treatment. Only 137 participants will receive “sham” treatment whereas 274 will be allocated to active treatment, so you have twice the chance of receiving active treatment as “sham” treatment.

Participants in both groups will then attend hospital monthly, and receive an Lucentis® injection if their disease is active at any of those visits.

You will be in this study for four years. You will be scheduled to come to the clinic three times in the first two months and then every month for the first two years. For the remaining two years you will have two study visits, one at the end of the third year and one at the end of the fourth year. In between these two visits you will attend the clinic to receive standard NHS care, as appropriate.

Find a Study Site