All studies
Enrolling by invitationOBSERVATIONAL

Deciphering AMD by Deep Phenotyping and Machine Learning- Prospective Study - SUMMIT (Part 2)

The SUMMIT study is an extension of a previous study called PINNACLE, focusing on Age-related Macular Degeneration (AMD), a common eye condition. We're inviting people who successfully completed the PINNACLE study to continue participating for another two years. The main goal is to closely monitor how intermediate AMD changes over time, specifically looking for the very first signs that it might be developing into more advanced forms. Participants will have regular eye scans and tests every four months. By combining the data from both PINNACLE and SUMMIT, we'll have five years of information, helping us understand the early stages of AMD progression much better.

At a glance

Status
Enrolling by invitation
Sponsor
University of Southampton
Enrolment target
300
Start
12 Jun 2024
Estimated completion
30 Jun 2027

What is this study about?

This study, called SUMMIT, is a follow-up to an earlier study named PINNACLE. Both studies are looking into Age-related Macular Degeneration (AMD), a common eye condition that affects the central part of your vision. Specifically, we're interested in 'intermediate AMD' – a middle stage of the condition. We want to understand exactly how intermediate AMD progresses and what subtle changes happen in the eye before it becomes more advanced AMD.

To do this, we're inviting people who successfully completed the PINNACLE study to continue their involvement with SUMMIT for another two years. During this time, we'll continue using advanced imaging techniques, like special eye scans, to monitor their eyes very closely. By tracking these changes over a longer period (five years in total when combined with the PINNACLE study), we hope to spot the earliest indicators of disease progression. This detailed information will be crucial for scientists and doctors to better understand AMD.

Ultimately, this research aims to improve our knowledge of AMD. By identifying these early signs, it could one day help in developing new ways to diagnose the condition sooner or even slow down its progression, potentially preserving people's eyesight. This is a non-interventional study, meaning you won't receive any new treatments; we are simply observing the changes in your eyes.

Key takeaways

  • This study continues research on Age-related Macular Degeneration (AMD).
  • It aims to identify early signs of AMD worsening over time.
  • Only previous participants from the PINNACLE study can join.
  • Participation involves regular eye check-ups and scans for up to two years.
  • Your involvement helps improve understanding and potentially future treatments for AMD.
  • This is an observational study; no new treatments are given.

Who may be eligible?

This study is specifically for people who have already taken part in and successfully completed the PINNACLE study. You must have finished your last PINNACLE study visit within the past 12 months. It's important that you also haven't withdrawn from the PINNACLE study at any point.

You should have a continuing diagnosis of intermediate AMD in at least one eye. This means your eyes show specific signs of intermediate AMD, which your study doctor will confirm. Importantly, your eyes need to be clear enough for us to take good quality images and perform eye tests, and you should be able to attend appointments every four months.

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. Did you complete the PINNACLE study, including your final visit?
  2. Was your last PINNACLE study visit within the last 12 months?
  3. Do you continue to have intermediate AMD in at least one eye?
  4. Can you attend appointments every four months for up to two years?
  5. Are your eyes clear enough for detailed scans and tests?
Answer every question to see your result.

What does participation involve?

If you join the SUMMIT study, you'll continue to have regular check-ups every four months for up to two years. Each visit will involve various eye tests and imaging. These include special scans of your eye (like OCT scans) and tests to check your vision. We will also update your medical history and medication details.

You will attend a maximum of six visits in total over the two years. Two of these visits, at months 48 and 60 (which are 16 months and 24 months into SUMMIT respectively), will be more detailed 'annual' check-ups with extra imaging and tests. The information gathered from your original PINNACLE study, including your birth year, smoking habits, body mass index, and genetic information, will be used in SUMMIT's analysis – we won't recolour these details.

Potential risks and benefits

The main benefit of taking part is contributing valuable information to help us better understand Age-related Macular Degeneration, which could lead to improved diagnosis and care in the future. As this is an observational study, you won't receive any new treatments, but your eyes will be monitored closely. The risks are generally low, mainly involving the time commitment for appointments and the mild discomfort associated with eye examinations, such as bright lights during scans. You are free to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Medical University of Vienna
    Verified postcode
    Vienna, Austria
  • The Princess Alexandra Hospital Nhs Foundation Trust
    Verified postcode
    Harlow, United Kingdom
  • University Hospital Southampton
    Verified postcode
    Southampton, United Kingdom
  • St Mary's Hospital
    Verified postcode
    Newport, United Kingdom
  • John Radcliffe Hospital
    Verified postcode
    Oxford, United Kingdom
  • Frimley Health Nhs Foundation Trust
    Verified postcode
    Frimley, United Kingdom
  • Salisbury Nhs Foundation Trust
    Verified postcode
    Salisbury, United Kingdom
  • Moorfields Eye Hospital
    Verified postcode
    London, United Kingdom

Common questions

What is Age-related Macular Degeneration (AMD)?

AMD is a common eye condition that affects the central part of your vision, making it harder to see fine details.

What does 'intermediate AMD' mean?

Intermediate AMD is a middle stage of the condition, where there are specific changes in the eye but usually without severe vision loss yet.

Why is this study important?

This study helps us understand how intermediate AMD progresses to more advanced forms, which could lead to earlier diagnosis and better treatments in the future.

Will I receive any new treatment in this study?

No, this is an 'observational' study. We will be monitoring your eyes, but you won't be given any new treatments as part of this research.

How long will I be in the study?

You'll be in the study for up to two additional years, with check-ups every four months.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Deciphering AMD by Deep Phenotyping and Machine Learning- Pr…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.