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New study monitors eylea in premature Babies' eye disease

NCT ID NCT05705258

Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study follows 75 Japanese babies with retinopathy of prematurity (ROP) who are being treated with Eylea, a drug injected into the eye. ROP causes abnormal blood vessel growth in the retina and can lead to blindness. The study collects real-world data on side effects and how well the drug works over 6 months. No extra tests are done beyond routine care.

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 successful, this study could confirm that Eylea is a safe and effective treatment for ROP in Japanese babies, helping prevent blindness.
What could go wrong
This is an observational study with no control group, so results are less definitive. It only includes Japanese babies, so findings may not apply to other populations.

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 75 people

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

Started

Mar 2023

Expected to finish

Mar 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

Patients with a diagnosis of ROP will be enrolled after the decision for treatment with AFL has been made by the investigator. Patients who have been prescribed AFL in accordance with the product label in Japan will be eligible to be enrolled. Indications and contraindications according to the local market authorization should be carefully considered.

Ages

Up to 2 years

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: * Diagnosis of ROP requiring treatment * Patients who have received IVT-AFL treatment according to Japanese approved labeling for AFL in ROP. * ICF obtained from legal representative. Exclusion Criteria: * Patients who have contradictions based on approved label * Patients who have received IVT-AFL treatment before the treatment for the enrollment Patient. * Diagnosis of other indication

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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.

Infants Newborns Retinopathy of prematurity

Contacts and locations

Locations

  • Many locations

    Multiple Locations, Japan

More trials for these conditions

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