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StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR)

Age-related macular degeneration (AMD) is a common condition affecting central vision. The 'wet' form can cause sight to worsen rapidly if untreated. Currently, patients need regular, ongoing injections directly into their eye to protect their sight. The STAR study is investigating a treatment called stereotactic radiotherapy. This uses a robotic device to focus gentle, precise beams of radiation onto the back of the eye. Researchers want to find out whether combining this radiation treatment with standard eye injections can protect vision while reducing how often patients need injections. Participants are randomly placed into one of two groups: one receives real radiation, and the other receives a simulated (placebo) treatment. Everyone continues to receive eye injections whenever their condition requires them. The study follows participants for four years to check safety and sight outcomes.

Överblick

Status
Avslutad
Fas
Ej tillämpligt
Inskrivningsmål
411
Starta
01 Dec 2014
Beräknad slutförande
31 Dec 2019
Retinal disease/age-related macular degeneration

Vad handlar denna studie om?

Age-related macular degeneration, often called AMD, is a painless eye condition that affects the macula—the central part of the eye responsible for sharp, detailed vision. When you have 'wet' AMD, abnormal blood vessels leak fluid or blood into the retina. Without prompt treatment, this leakage can cause quick and permanent loss of central vision, making activities like reading, driving, or recognising faces very difficult.

The usual treatment for wet AMD involves regular injections of medicine into the eye. While these injections work well to protect sight, needing them every few weeks or months can be difficult and stressful for patients. The STAR study looks at a new approach called stereotactic radiotherapy, which uses a robotic machine to deliver pinpoint beams of radiation straight to the affected area.

Doctors hope that this radiation treatment will help dry up leaky blood vessels, reduce swelling, and either lower the number of eye injections people need or remove the need for them altogether. By comparing patients who receive the radiation treatment against those who receive a dummy treatment, researchers can clearly see if this method is safe and effective.

Viktiga punkter

  • Tests whether targeted radiation can reduce the need for regular eye injections in wet AMD.
  • Open to adults aged 50 and over who are currently receiving eye injections.
  • Participants are randomly chosen to receive either real radiation or a dummy treatment.
  • Everyone continues to receive eye injections whenever their eye needs them.
  • The study runs for four years to check both effectiveness and long-term safety.

Vem kan vara berättigad?

This study is open to men and women aged 50 and over who have wet AMD in at least one eye and currently need eye injections. To qualify, you must have already had at least three eye injections for your wet AMD, with at least one given in the last three months, and your eye specialist must see signs that your condition is currently active.

You might not be able to take part if you have severe scarring in the centre of your retina, or if your vision in the affected eye has already dropped below a specific level. The trial also excludes people with unusually small or large eye shapes, or those who cannot wear a contact lens during the procedure.

Kan denna studie passa dig?

Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.

  1. I am 50 years of age or older.
  2. I have been diagnosed with wet age-related macular degeneration (wet AMD).
  3. I have had at least three eye injections for wet AMD in the study eye.
  4. I have had an eye injection within the last three months.
  5. My eye doctor says my wet AMD is still active and requires ongoing treatment.
Svara på varje fråga för att se ditt resultat.

Vad innebär deltagande?

If you take part in the STAR study, you will be placed at random into one of two groups. One group receives the actual stereotactic radiation treatment, while the other group receives a harmless simulated (placebo) treatment that feels similar. Neither you nor your regular eye doctor will know which group you are in.

The study lasts for four years. During the first two years, you will attend regular hospital appointments for eye checks, scans, and standard injections (such as Lucentis) whenever your eye shows signs of active fluid. In years three and four, you will have fewer visits, focused on long-term safety and vision checks.

Potentiella risker och fördelar

Taking part may mean you need fewer eye injections to protect your sight, and some past research suggests radiation might offer better visual outcomes when paired with injections. However, radiation carries a small risk of damaging healthy eye tissues, which could affect your vision. Routine scans will monitor your eyes closely throughout the trial. Participation is completely voluntary, and you can withdraw at any time without your regular NHS care being affected.

Platser (28)

  • King's College Hospital
    Ungefärlig
    London, England
  • University Hospitals Bristol NHS Trust
    Endast stad
    Bristol, England
  • Frimley Park Hospital
    Ungefärlig
    Camberley, England
  • Maidstone and Tunbridge Wells NHS Trust
    Endast stad
    Maidstone, England
  • The Royal Wolverhampton NHS Trust
    Endast stad
    Wolverhampton, England
  • East Lancashire Hospitals NHS Trust
    Obekräftad
    Blackburn, England
  • The Sussex Eye Hospital
    Obekräftad
    Brighton, England
  • William Harvey Hospital
    Obekräftad
    Ashford, England
  • Hillingdon Hospital
    Obekräftad
    Uxbridge, England
  • Whipps Cross University Hospital NHS Trust
    Obekräftad
    London, England
  • Prinsessan Alexandra Sjukhus
    Obekräftad
    Harlow, England
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
    Obekräftad
    Norwich, England

Vanliga frågor

Does the radiation treatment hurt?

No. The radiation beams themselves are completely painless, and numbing drops are used to keep your eye comfortable.

Will I still get my regular eye injections?

Yes. If your eye shows signs of active fluid or swelling at any visit, you will receive standard eye injections just as you normally would.

What is a sham or simulated treatment?

A sham treatment is a dummy procedure designed to look and feel like the real treatment without delivering any radiation. This helps doctors fairly compare results.

Hur länge kommer jag att vara involverad i studien?

You will be followed up closely for two years, with extra safety check-ups at the end of years three and four, making four years in total.

Kan jag lämna studien om jag ändrar mig?

Yes. You are free to stop participating at any time, and doing so will never affect your standard NHS medical care.

Hur du får reda på mer

Riti Desai

ritidesai@nhs.net +44 (0)20 3299 1297 Officiell rättegångsprotokoll

Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.

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