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Data Use Application 017

Lead applicant organisation name

Name of the legal entity that signs the contract to access the data.

Moorfields Eye Hospital NHS Foundation Trust; University College London. Lead applicant: Ariel Ong, NIHR Doctoral Fellow

Project title

The title of the project/research study request that the applicant is investigating through the use of health data.

Baseline characterisation of patients prescribed Aflibercept 8 mg intravitreal injection for the treatment of nAMD and DMO: A drug utilisation study using the Moorfields INSIGHT research database

Lay summary

A concise and clear description of the project.  This should outline the problem, objective and the expected outcomes in language that is understandable to the general public.

For many years, patients have received Aflibercept 2mg eye injections, which is effective but often requires regular injections. The newer 8 mg dose, first introduced in 2024, may allow some patients to have longer gaps between treatments. However, there is little real-world information on how patients respond to the 8 mg dose outside of clinical trials, and what happens when people switch from one anti-VEGF medicine to another. Understanding these questions is important because many individuals rely on these treatments to maintain their sight.

This study aims to understand how Aflibercept 8 mg is being used in routine care for people with wet age-related macular degeneration (nAMD) and diabetic macular oedema (DMO) at Moorfields Eye Hospital. It will use clinical and imaging data to track real-world patterns of treatment and outcomes to provide the early and medium-term evidence on how Aflibercept 8 mg performs in routine care. By studying both newly treated and previously treated patients, the findings are intended to build a clearer picture of its practical benefits, limitations, and patterns of use in everyday care.

The study will run for up to 24 months following each patient case from the time they begin Aflibercept 8 mg until the study ends or follow-up naturally stops. Three planned interim analyses are intended to show how treatment use and outcomes develop over time. This study forms part of a project that INSIGHT at Moorfields is undertaking for Bayer PLC.

Public benefit statement

A description in plain English of the anticipated outcomes, or impact of project on the general public.

This study has important public health implications since nAMD and DMO are leading causes of vision loss in the UK, and demand for treatment continues to grow. Reliable real-world evidence on newer therapies may support better clinical decision-making, help services plan capacity more effectively, and give patients clearer expectations about their future vision and treatment needs.

NHS clinics for nAMD and DMO are among the most stretched services in ophthalmology, with large numbers of patients attending frequently for injections. Small changes in treatment durability can produce major effects for both patients and services. The study addresses a clear gap in evidence on the impact of the Aflibercept 8 mg dose since its widespread rollout for routine use.

By generating early, real-world evidence, the study will provide insights on patient treatment, including clearer estimates of the likelihood of achieving longer intervals between injections, expected visual trajectories, and outcomes after switching from other agents. These findings will support more personalised counselling and allow individuals to plan their lives around treatment.

For clinical teams, the study will help to show the true impact of switching from 2 mg to 8 mg, which is essential for efficient service planning and for refining treatment pathways. On a broader level, it builds an evidence base that may support equitable access to newer treatments, guide national policy on intravitreal service provision, and help shape future cost-effective models of care.

Latest approval date

The last date the data access request for this project was approved by a data custodian.

16/01/2026

Dataset(s) name

The name of the dataset(s) being accessed.

Bespoke: Intravitreal injections of Aflibercept 8mg

Access type

Determines whether the data will be accessed with an Trusted Research Environment (TRE) or via data release.

Data provisioned to the research applicant through INSIGHT's Secure Research Environment

Data sensitivity level

The level of identifiability of the data being accessed, as defined by Understanding Patient Data.

Anonymised

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