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AuthorisedPhase III and phase IV (Integrated)Interventional

Multicentre, randomised, double-blind, parallel-group, Phase III study to evaluate the genetic polymorphisms influence in the response to Ranibizumab and Bevacizumab treatment in patients with Age-Associated Macular Degeneration

This research is a big study (Phase III) comparing two common medicines, ranibizumab (Lucentis) and bevacizumab (Avastin), for treating Age-Related Macular Degeneration (AMD). AMD is an eye condition that can blur central vision. Doctors want to understand if one medicine works better than the other, and importantly, if differences in people's genes (their DNA) might explain why some people respond well to a treatment and others don't. They will measure changes in eyesight over one year. The study involves collecting saliva for genetic testing and regularly checking participants' vision to see how the treatments are working. This information could help doctors choose the best treatment for individuals in the future.

At a glance

Status
Authorised
Phase
Phase III and phase IV (Integrated)
Sponsor
Consorci Mar Parc De Salut De Barcelona
Enrolment target
574
Start
25 Oct 2024

What is this study about?

This study is a detailed look into how different treatments work for a common eye condition called Age-Related Macular Degeneration (AMD). AMD affects the central part of your vision, making everyday tasks like reading and recognising faces more difficult. The study focuses on two main medicines, ranibizumab and bevacizumab, which are often used to treat AMD.

The main aim is to see how much a person's eyesight improves after receiving these treatments over a year. But it's not just about which medicine is 'better'. A really important part of this research is trying to understand if our genes – the unique instructions inside our bodies – play a role in how well these medicines work for each person. You might wonder why some people respond really well to a treatment, while others don't see as much improvement. This study hopes to find some answers by looking at genetic differences.

By understanding the link between our genes and how we respond to AMD treatments, doctors might one day be able to offer more personalised care. This means choosing the most effective medicine for you based on your individual genetic make-up, rather than a more general approach. This kind of research is a big step towards making eye care even better in the future.

Key takeaways

  • Compares two common AMD eye injection medicines.
  • Investigates if genes affect treatment effectiveness.
  • Aims to improve personalised AMD treatment.
  • Involves regular eye checks and a saliva sample.
  • Lasts about one year.

Who may be eligible?

This study is looking for volunteers with Age-Related Macular Degeneration (AMD).

To join, you must be 18 years old or older. There is no upper age limit, so older adults are welcome to participate. Both men and women can take part in this research.

The research team will have other specific medical criteria to make sure the study is safe and effective for everyone involved. They will check your medical history and eye health during an initial screening to see if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do I have Age-Related Macular Degeneration (AMD)?
  2. Am I 18 years old or older?
  3. Am I comfortable with receiving eye injections?
  4. Am I willing to provide a saliva sample?
  5. Can I attend regular appointments for about a year?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to receive either ranibizumab or bevacizumab. You won't know which one you are getting, and neither will your doctor – this is common in research to ensure fairness. Both medicines are given as injections into the eye.

Throughout the study, you'll have regular appointments where your eyesight will be carefully checked using special charts, similar to those you might see at an optician. These measurements will help the doctors track how well the treatment is working. At one point, you will be asked to provide a saliva sample, usually by gently rubbing a swab inside your mouth. This sample will be used to look at your genetic information.

These check-ups, treatments, and saliva collection will happen over a period of about one year. After this, there might be further follow-up appointments depending on the study design. The exact number and timing of visits will be explained in detail by the research team.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as receiving close medical care for your Age-Related Macular Degeneration and contributing to knowledge that could help future patients. However, there are also potential risks involved. These might include side effects from the eye injections, which could range from mild discomfort to more serious, though rare, complications. The research team will explain all known risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Spain

Common questions

What is Age-Related Macular Degeneration (AMD)?

AMD is an eye condition that can make your central vision blurry or distorted, making it harder to read or see fine details.

What are ranibizumab and bevacizumab?

These are two common medicines given as injections into the eye to help slow down vision loss from certain types of AMD.

What is a 'genetic polymorphism'?

This refers to slight differences in a person's genes (DNA) that make individuals unique. Researchers want to see if these differences affect how well AMD medicines work.

How will my eyesight be checked?

Your vision will be measured using special eye charts, similar to those you'd encounter during a regular eye test, at your study appointments.

Is giving a saliva sample painful?

No, it's a very simple and pain-free process, usually done by rubbing a soft swab inside your cheek to collect some saliva.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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