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UK study counts how many preterm babies get eylea for eye disease

NCT ID NCT06315556

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 5 times

Summary

This observational study collects data from UK preterm babies with retinopathy of prematurity (ROP) who are treated with the drug aflibercept (Eylea) using a paediatric dosing device. The main goal is to count how many babies receive this treatment and decide if there are enough to run a future long-term safety study. No extra visits or tests are needed—only existing hospital records are used.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aflibercept (Eylea)
What this could lead to
If enough babies are treated, this study could pave the way for a larger safety study on long-term effects of Eylea in preterm infants with ROP.
What could go wrong
This is an observational study that only counts cases and describes patient traits—it does not test whether the treatment works or is safe. The number of treated babies may be too small to proceed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All premature infants diagnosed with ROP and treated with Eylea PFS + PDD included in the National Neonatal Research Database (NNRD) during the study period in the UK.

Ages

Up to 1 year

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Eligible infants within the NNRD include those who were: * 1\. Born during the study period, i.e. from Q4/2023 following market introduction of Eylea PFS+PDD and 31st December 2026, and * 2\. Received care in a neonatal unit that contributes data to the NNRD and the unit has agreed to participate in the study, and * 3\. Diagnosed with ROP in any stage in at least one eye. Exclusion Criteria: * Infants with missing data for gestational age at birth will be excluded.

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Conditions

The condition(s) this trial relates to.

retinopathy of prematurity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Preterm infants Retinopathy of prematurity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Many locations

    RECRUITING

    Multiple Locations, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.