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Long-Term Study on Aflibercept for Retinopathy of Prematurity in Infants

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term effects of a treatment for a condition called retinopathy of prematurity (ROP). ROP is an eye disease that affects premature babies, where abnormal blood vessels grow in the retina, the part of the eye that senses light. The treatment being studied involves a medication called aflibercept, which is marketed under the name Eylea. Eylea is a solution that is injected into the eye to help manage the condition.

The purpose of this study is to evaluate the long-term safety and visual outcomes of children who received this treatment in a previous study. Participants in this study will be monitored over several years to assess their vision and any potential side effects. The study will look at how well the children can see at different ages and whether they experience any eye-related or general health issues. It will also check for any structural changes in the eye, such as retinal detachment, which is when the retina pulls away from its normal position.

Throughout the study, researchers will also evaluate the children's overall development using standardized tests. These tests will help determine if the treatment has any impact on their growth and learning abilities. The study aims to provide valuable information on the long-term effects of using Eylea for treating retinopathy of prematurity, helping to improve future care for children with this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after treatment in Study 20090. Eligibility requires being under 13 months old and having signed consent from a parent or legal representative.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current visual function and overall health. This includes checking for any adverse effects from previous treatments.

  3. Step 3

    Treatment administration

    The medication used is Eylea 40 mg/mL solution for injection. It is administered through intravitreal use, which means it is injected into the eye. The frequency and duration of administration depend on the individual needs and the progression of the condition.

  4. Step 4

    Regular follow-up visits

    Regular follow-up visits are scheduled to monitor visual acuity and check for any adverse events. These visits occur at various intervals, including 1, 3, and 5 years of age.

  5. Step 5

    Visual and developmental assessments

    Visual acuity is assessed using the Snellen equivalent score at 5 years of age. Additional assessments include checking for ocular and systemic adverse events, as well as neurodevelopmental outcomes using standardized tests.

  6. Step 6

    Final evaluation

    A final evaluation is conducted at the end of the study to determine the long-term safety and effectiveness of the treatment. This includes a comprehensive review of visual function and any structural changes in the eye.

Who can join the trial?

3 criteria

  • The patient must have been treated in a previous study called Study 20090.
  • The patient must be less than 13 months old.
  • The patient's parent(s) or legally authorized representative(s) must sign an informed consent form. This form explains the study and includes rules and requirements that need to be followed.

Who cannot join the trial?

5 criteria

  • Patients who have a different eye condition other than retinopathy of prematurity cannot participate. Retinopathy of prematurity is an eye disease that affects premature babies.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who have not been part of the previous Study 20090 cannot participate.
  • Patients with any other medical condition that might interfere with the study cannot participate.
  • Patients who are unable to follow the study procedures cannot participate.
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Investigated drugs

Study Medication 20090 is a treatment used for retinopathy of prematurity, a condition that affects the eyes of premature infants. This medication is being evaluated for its long-term safety and effectiveness in improving visual function in patients who participated in the initial study.

What is already known about the treatment

Bevacizumab – Bevacizumab is administered as an injection directly into the eye. It is currently being studied for its long-term effects in treating retinopathy of prematurity, a condition affecting premature infants. The medication works by inhibiting a protein called vascular endothelial growth factor (VEGF), which is responsible for the growth of abnormal blood vessels in the eye. Bevacizumab is classified as an anti-VEGF agent and is commonly used in various eye conditions to prevent vision loss.

Investigated diseases

Retinopathy of Prematurity – This disease affects the eyes of premature infants, primarily those born before 31 weeks of gestation. It occurs when abnormal blood vessels grow in the retina, the light-sensitive layer of cells at the back of the eye. As the disease progresses, these vessels can leak or cause scarring, potentially leading to retinal detachment. In its early stages, retinopathy of prematurity may not show any symptoms, but as it advances, it can result in vision problems or even blindness. The condition is categorized into different stages, with higher stages indicating more severe disease. Monitoring and timely intervention are crucial to manage the progression and prevent long-term visual impairment.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-504207-89-00Protocol code20275Estimated enrolment97 patientsSponsorBayer AG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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