Active not recruitingOBSERVATIONAL

The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in Treating Visual Impairment Due to Neovascular Age-related Macular Degeneration or Diabetic Macula Edema

The SPECTRUM Study is an important project aimed at understanding how a medicine called aflibercept 8 mg helps people with vision loss. This medicine treats two eye conditions: 'wet' Age-related Macular Degeneration (nAMD) and Diabetic Macular Oedema (DME). In these conditions, abnormal blood vessels leak fluid in the eye, affecting central vision. This study isn't doing new tests or treatments; it's simply collecting information from the medical records of patients in the UK who are already receiving aflibercept 8 mg as part of their routine eye care. The goal is to see how well the medicine works in real-world situations, especially regarding vision improvements over 12 months.

At a glance

Status

Active not recruiting

Sponsor

Bayer

Enrolment target

2,500

Start

15 Feb 2024

Estimated completion

31 Jan 2028

Visual Impairment Neovascular Age-related Macular Degeneration (nAMD)Diabetic Macula Edema (DME)

What is this study about?

Imagine your eye doctor has prescribed you a new medicine called aflibercept 8 mg for your vision problems caused by 'wet' Age-related Macular Degeneration (nAMD) or Diabetic Macular Oedema (DME). The SPECTRUM Study is like a careful observer, gathering information about how well this medicine works for people like you who are already receiving it in their regular clinic visits. Think of it as collecting 'real-world' evidence.

Let's break down the conditions. nAMD, often called 'wet' AMD, affects older adults and can cause blurry or distorted central vision because abnormal blood vessels grow and leak fluid at the back of the eye. DME, on the other hand, is a complication of diabetes where blood vessels in the eye leak, causing the central part of your retina (the macula) to swell, leading to vision problems. Aflibercept 8 mg is an injection given in the eye that helps by blocking a protein that causes these leaky blood vessels to grow.

The main question researchers want to answer is: how much does vision improve for people taking aflibercept 8 mg? They will be looking at changes in vision test scores over 12 months. This study is important because while clinical trials have shown the medicine works, this study will show how it works in day-to-day healthcare settings, whether you've had previous treatments or not. It's about making sure new medicines are as effective as we hope, for real patients.

Key takeaways

Aflibercept 8 mg is an eye injection for 'wet' AMD and diabetic macular oedema.
This study observes how well the medicine works in routine care, not a new treatment.
No extra appointments or procedures are needed for patients in the study.
Your routine vision test results will be used to see if your vision improves.
Your participation helps doctors understand the medicine better for future patients.

Who may be eligible?

To be part of this study, you must be an adult aged 50 or over if you have 'wet' Age-related Macular Degeneration (nAMD), or 18 or over if you have Diabetic Macular Oedema (DME). You must also have been diagnosed with one of these conditions.

The most important thing is that your doctor has already decided to treat you with aflibercept 8 mg as part of your usual care. This study isn't about trying a new treatment; it's about observing how this medicine works for patients who are already receiving it. Before any information about you is collected, you'll need to give your signed permission.

However, you wouldn't be able to take part if you're involved in another research study that involves new treatments, if aflibercept 8 mg isn't suitable for you for other medical reasons (as detailed in the medicine's information), or if you have certain eye infections or inflammation. Also, if you've recently had other eye treatments that might interfere with aflibercept 8 mg, you might not be eligible.

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 aged 50 or over with 'wet' AMD, or 18 or over with diabetic macular oedema?
Has your eye doctor already prescribed aflibercept 8 mg for you?
Are you willing to give your written permission for your medical information to be used?
Are you currently not taking part in another research study that involves new treatments?
Do you have no current eye infections or other medical reasons why aflibercept 8 mg wouldn't be suitable for you?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the SPECTRUM Study, you won't need to do anything extra. This study simply collects information from your existing medical records and from conversations with your doctor during your routine clinic visits for aflibercept 8 mg treatment. You won't have any additional appointments, tests, or procedures because of this study.

The researchers will observe your progress from your very first injection of aflibercept 8 mg. They will collect data that is already part of your regular medical checks, such as your vision test scores. The information will be gathered between February 2024 and September 2027, and for each patient, data will be collected for up to 24 months. You'll continue to receive your aflibercept 8 mg injections as prescribed by your doctor and attend your regular follow-up appointments, just as you would have done anyway.

Potential risks and benefits

Participating in this study comes with no direct physical risks, as it only involves collecting information from your existing medical records and routine appointments; no new treatments or procedures are involved. There are also no direct personal benefits for you, as the study doesn't change the care you receive. However, by allowing your information to be used, you'll be contributing to a better understanding of how aflibercept 8 mg works in real-world settings, which could help future patients with similar conditions. You are always free to withdraw your consent at any time without affecting your medical care.

Locations (18)

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

Many Locations
Unverified
Multiple Locations, Australia
Many Locations
Unverified
Multiple Locations, Canada
Many Locations
Unverified
Multiple Locations, Denmark
Many Locations
Unverified
Multiple Locations, Finland
Many Locations
Unverified
Multiple Locations, France
Many Locations
Unverified
Multiple Locations, Germany
Many Locations
Unverified
Multiple Locations, Italy
Many Locations
Unverified
Multiple Locations, Japan
Many Locations
Unverified
Multiple Locations, Netherlands
Many Locations
Unverified
Multiple Locations, Norway
Many Locations
Unverified
Multiple Locations, Portugal
Many Locations
Unverified
Multiple Locations, Saudi Arabia

Common questions

Will I receive a different treatment if I join this study?

No, this study doesn't involve any new treatments. You will receive aflibercept 8 mg exactly as your doctor has prescribed for your usual care.

Do I need extra doctor visits for this study?

No, there are no extra visits or tests required. All information is collected during your routine clinic appointments.

What information will the study collect about me?

The study will mainly collect information about how your vision changes over time, using your regular vision test results.

Can I decide not to be part of the study after I've agreed?

Yes, you can withdraw your permission for your data to be used at any time, and it won't affect your medical care.

Why is this study being done?

It's being done to gather more information on how well aflibercept 8 mg works for people with nAMD and DME in real-life healthcare settings.