SPECTRUM - Observational Study
Research type
Research Study
Full title
An observational study program to investigate the effectiveness of Aflibercept 8mg used in DME and nAMD in a real-world setting
IRAS ID
336005
Contact name
Clare Bailey
Contact email
Sponsor organisation
Bayer
Duration of Study in the UK
3 years, 7 months, 31 days
Research summary
Neovascular Age-Related Macular Degeneration (nAMD). This is an eye problem that mostly affects older people. It happens when new, abnormal blood vessels grow in the back of the eye. These abnormal vessels can cause vision problems.
Diabetic Macular Oedema (DMO): This is a condition that can affect people with diabetes. It occurs when the part of the eye responsible for clear, sharp vision (the macula) swells due to diabetes-related issues. This can make your vision blurry or wavy.
Aflibercept 2mg is a medicine that's already approved for various health issues worldwide. To make it easier for patients to use, new formulation was developed, which has 8mg in it instead of 2mg. In large studies with patients who have eye problems, it was found that most of them could receive the new medicine less often after an initial round of treatment without it becoming less effective or less safe. The new version, Aflibercept 8mg, is currently going through approval for use. Current study will be looking at how well and how safely this new version works in real-world situations for up to 2 years. It will be given to patients with eye problems like Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic macular Oedema (DMO) in different countries. The goal is to understand how good it is at helping patients in the long run when used in a regular clinical setting.
Patients will be put into two groups by their doctors: one for patients who haven't had any previous treatments, and another for those who have received treatments like laser, steroids, or anti-VEGF drugs. Aflibercept 8mg will be given to patients by intraviteral injection, injected directly into the gel-like substance inside the eye.
REC name
West of Scotland REC 5
REC reference
23/WS/0180
Date of REC Opinion
6 Dec 2023
REC opinion
Favourable Opinion