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

Verified siteRegistered drugNo placebo
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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 infants, potentially leading to vision problems. The treatment being evaluated in this study is a medication called Eylea, which is a solution for injection containing the active substance Aflibercept. This medication is administered through an injection into the eye, a method known as intravitreal use.

The purpose of this study is to assess the long-term outcomes in children who previously received treatment for ROP in an earlier study. Researchers aim to evaluate the children's visual acuity, which refers to the clarity or sharpness of vision, and to monitor the safety of the treatment over time. The study will also look at other aspects of eye health and development, such as the structure of the eye and neurodevelopmental outcomes, which involve the development of the brain and nervous system.

Participants in this study will be monitored over a period of time to gather information on their vision and overall health. The study will help determine how effective and safe the treatment is in the long run for children who have been affected by ROP. This information is crucial for understanding the potential benefits and risks of using Eylea in treating this condition.

The research process

The trial runs in 5 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 receiving treatment in the VGFTe-ROP-1920 study for retinopathy of prematurity (ROP).

    Eligibility requires being under 13 months of age and having signed informed consent from a parent or legal guardian.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current condition of the eyes and overall health.

    This includes measuring binocular best-corrected visual acuity (BCVA) and checking for any adverse events.

  3. Step 3

    Treatment administration

    The medication used is Eylea 40 mg/mL solution for injection, administered through intravitreal use (injection into the eye).

    The frequency and duration of administration are determined based on individual needs and the study protocol.

  4. Step 4

    Ongoing monitoring

    Regular follow-up visits are scheduled to monitor visual acuity and check for any adverse effects.

    Additional assessments may include evaluating neurodevelopmental outcomes using standardized tests such as BSID-III, WPPSI-IV, and VABS-II.

  5. Step 5

    Final evaluation

    At the end of the study, a comprehensive evaluation is conducted to assess long-term outcomes.

    This includes measuring BCVA, checking for any recurrence of ROP, and evaluating the need for further treatment.

Who can join the trial?

3 criteria

  • The patient must have been treated in a previous study called VGFTe-ROP-1920.
  • The patient must be less than 13 months old. This means the patient should not have reached their first birthday and one additional month.
  • The parent(s) or legal guardian(s) must sign an informed consent form. This form shows they agree to the study's rules and understand what is involved.

Who cannot join the trial?

5 criteria

  • Patients who have not participated in the VGFTe-ROP-1920 study.
  • Patients with medical conditions other than Retinopathy of Prematurity (ROP), which is an eye disease that can affect premature babies.
  • Patients who are not within the specified age range for the study.
  • Patients who do not meet the gender requirements, as the study includes both male and female subjects.
  • Patients who are not considered part of a vulnerable population, which means they do not need special protection or care.
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Investigated drugs

VGFTe-ROP-1920 is a medication being studied for its effects on retinopathy of prematurity (ROP), a condition that affects the eyes of premature infants. This study aims to evaluate the long-term outcomes and safety of patients who received this treatment in a previous study. The medication is designed to help improve visual acuity and manage the condition over time.

What is already known about the treatment

Ranibizumab – This medication is administered through an injection into the eye and is used to treat retinopathy of prematurity (ROP), a condition affecting premature infants. It is currently being studied in clinical trials to assess its long-term safety and effectiveness. Ranibizumab works by inhibiting a protein called vascular endothelial growth factor (VEGF), which plays a role in the formation of abnormal blood vessels in the eye. It is classified as an anti-VEGF agent and is commonly used in ophthalmology to manage various retinal conditions.

Investigated diseases

Retinopathy of Prematurity (ROP) – This is a disease that affects the eyes of premature infants. It occurs when abnormal blood vessels grow in the retina, the light-sensitive layer of cells at the back of the eye. These abnormal vessels can cause the retina to detach from the back of the eye, leading to vision problems. The disease progresses in stages, starting with mild changes in the retina and potentially advancing to more severe stages where the retina may detach. The progression can vary, with some infants experiencing spontaneous improvement, while others may develop more serious complications. Monitoring and timely intervention are crucial to manage the condition effectively.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-513231-24-00Protocol codeVGFTe-ROP-2036Estimated enrolment84 patientsSponsorRegeneron Pharmaceuticals Inc.

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