Deciphering AMD by Deep Phenotyping and Machine Learning- Prospective Study - PINNACLE
The PINNACLE study aims to understand how Age-related Macular Degeneration (AMD) changes over time in its early stages. Researchers will follow 400 patients with early AMD for at least a year, using advanced eye scans (OCT) every four months. They want to spot the very first signs of the disease progressing. If changes are seen, further detailed checks will happen quickly. The goal is to learn more about how AMD develops, which could help discover better ways to diagnose and treat it in the future. This is a "no intervention" study, meaning participants won't receive new treatments as part of this research, but their eye changes will be carefully monitored.
At a glance
What is this study about?
The PINNACLE study is an important research project looking into Age-related Macular Degeneration (AMD). AMD is an eye condition that affects the macula, the part of your eye responsible for sharp central vision. This study specifically focuses on people who are in the early stages of AMD. The main goal is to understand exactly how the disease changes and progresses before it reaches more advanced stages. By carefully watching these changes, researchers hope to gain new insights into AMD.
To do this, the study will involve 400 patients across the UK. Researchers will use special equipment, like a type of eye scan called OCT (Optical Coherence Tomography), to take detailed pictures of the back of your eye every four months. These scans are very precise and can show tiny changes that might indicate the disease is progressing. If any small changes are spotted, you might be asked to come in for more detailed examinations sooner than planned. This helps the researchers zoom in on those specific areas of change.
The information collected, along with details about your medical history and lifestyle, will be analysed using advanced techniques, including computer learning. This will help connect different pieces of information to build a clearer picture of how AMD develops. The knowledge gained from the PINNACLE study could be very valuable in improving our understanding of AMD, potentially leading to earlier detection and better ways to manage or treat the condition in the future.
Key takeaways
- The PINNACLE study monitors early AMD progression.
- It uses advanced eye scans (OCT) every four months.
- No new treatments are given; it's an observational study.
- Data collected will help understand AMD better for future patients.
- Participation involves regular clinic visits for tests and scans.
Who may be eligible?
This study is looking for people aged 55 to 90 years old. You might be suitable if you have intermediate AMD (a moderate stage of the condition) in both eyes. Alternatively, you could be eligible if you have intermediate AMD in one eye and a more advanced form of AMD (like geographic atrophy or wet AMD) in your other eye.
To take part, your eyes need to be clear enough for the special imaging tests, and you shouldn't have any other significant eye conditions, like severe glaucoma or very serious cataracts, that could affect your vision or the test results. Also, your short-sightedness shouldn't be too high.
Exclusions also include recent eye surgery or plans for surgery within six months of joining, and taking certain medications known to harm the retina. If you already have signs of advanced AMD, like certain types of fluid or scarring in your eye as seen on scans, you won't be able to join this particular study.
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.
- Are you between 55 and 90 years old?
- Do you have intermediate AMD in both eyes, OR intermediate AMD in one eye and advanced AMD in the other?
- Do you have good enough vision clarity for eye tests and scans?
- Do you NOT have severe other eye conditions like advanced glaucoma or very high levels of short-sightedness?
- Have you NOT had major eye surgery recently (within 3 months) and don't plan any in the next 6 months?
- Are you NOT taking medications known to harm the retina (e.g., certain cancer or arthritis drugs)?
What does participation involve?
If you join the PINNACLE study, you will have regular visits to your chosen clinic. Every four months, for at least one year, you will have detailed eye scans called OCTs. These scans check for any changes in your eyes. During these visits, you'll also have other eye tests, including special photographs of the back of your eye, visual function tests to measure your eyesight, and possibly other advanced imaging techniques like OCT angiography and autofluorescence.
Towards the beginning of the study (within the first year), a blood sample will be taken for DNA analysis. Some patients (about 200) will have even more in-depth tests during at least four visits. If the regular scans show any signs of change, you might be asked to come in for extra, more focused check-ups at specialist centres like the University of Southampton or Moorfields Eye Hospital. Throughout the study, your vision will be tested every year, and your medical and smoking history, as well as your weight, will be recorded. This study doesn't involve any new treatments; it's purely for observation and gathering information.
Potential risks and benefits
Locations (12)
- Medical University of ViennaVerified postcodeVienna, Austria
- University Hospital BaselVerified postcodeBasel, Switzerland
- The Princess Alexandra Hospital Nhs Foundation TrustVerified postcodeHarlow, United Kingdom
- University Hospital SouthamptonVerified postcodeSouthampton, United Kingdom
- St Mary's HospitalVerified postcodeNewport, United Kingdom
- John Radcliffe HospitalVerified postcodeOxford, United Kingdom
- Frimley Health Nhs Foundation TrustVerified postcodeFrimley, United Kingdom
- Salisbury Nhs Foundation TrustVerified postcodeSalisbury, United Kingdom
- University Hospitals Bristol and Weston Nhs Foundation TrustVerified postcodeBristol, United Kingdom
- Moorfields Eye HospitalVerified postcodeLondon, United Kingdom
- Guy'S and St Thomas' Nhs FtVerified postcodeLondon, United Kingdom
- St Mary's Hospital, Imperial College Healthcare NHS TrustVerified postcodeLondon, United Kingdom
Common questions
What is the main goal of the PINNACLE study?
The study aims to understand how early Age-related Macular Degeneration (AMD) changes and develops over time, to help us learn more about its progression.
Will I receive any new treatments in this study?
No, this study is 'non-interventional,' meaning you won't be given any new treatments. It focuses on observing and monitoring your eye changes.
How often will I need to visit the clinic?
You will need to attend clinic visits every four months for at least one year for eye scans and other tests.
What kind of tests will I have?
You'll have detailed eye scans (OCT), eye photographs, and visual function tests to measure your eyesight. A blood sample will also be taken.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time without having to give a reason, and it will not affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.