Collecting data on the use of Aflibercept in preterm babies with eye condition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather data on preterm infants diagnosed with retinopathy of prematurity (ROP) who are treated with Aflibercept (Eylea) using a pediatric dosing device. The study will collect information from neonatal units across the UK that participate in the National Neonatal Research Database (NNRD). By focusing on infants born during a specific period and receiving care in participating units, the study seeks to understand the application and outcomes of this treatment in a vulnerable population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Many locations
  Many Locations, United Kingdom Recruiting

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 0018888422937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Incidence of hypoxia during intravitreal ranibizumab injections for retinopathy of prematurity under topical anesthesia

  This study looks at how often and how severely babies with retinopathy of prematurity experience low oxygen levels during bedside eye injections with topical anesthesia.

  Recruiting Minia University · Buraidah · NCT07701759

• Standardized nutrition for very preterm infants

  This project will try a standardized, software-supported nutrition plan for babies born before 32 weeks to help them grow better and reduce complications.

  Recruiting at 4 sites Institute of Health Information and Statistics of the Czech Republic · Brno, Czech Republic and 4 other locations · NCT07364500

• Effects of Skin-to-Skin Care on Premature Infants

  This study tests if regular skin-to-skin care for premature babies can help them get more of their mother's milk and reduce health problems before they go home from the hospital.

  Recruiting Baskent University Ankara Hospital · Ankara · NCT06672913

• Understanding the intestinal immune system in newborns and its role in gastrointestinal diseases

  This study looks at how the immune system in newborns develops and how it relates to serious gut problems like NEC and bowel atresia, by collecting samples from both preterm and term infants.

  Recruiting at 2 sites Copenhagen University Hospital, Rigshospitalet · Copenhagen and 1 other locations · NCT06092463

• Using intranasal dexmedetomidine to manage pain during eye exams in premature infants

  This study tests if a nasal spray of dexmedetomidine can help reduce pain for premature infants during eye exams.

  Recruiting Phase 3 Assaf-Harofeh Medical Center · Be’er Ya‘aqov, Center · NCT06067958

• Imaging the blood vessels in the eyes of premature infants

  This study is testing how blood vessels in the eyes of premature infants grow to better understand retinopathy of prematurity and help prevent childhood blindness.

  Recruiting Duke University · Durham, North Carolina and 1 other locations · NCT05558059

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.