Ongoing Clinical Trials for Retinopathy of Prematurity
There are currently 3 clinical trials investigating new treatments and approaches for retinopathy of prematurity, a serious eye condition affecting premature infants. These studies are being conducted across multiple European countries and focus on preventing severe forms of the disease through different interventions, including oral medications, eye injections, and automatic oxygen control systems.
Clinical trial locations
- Belgium
- Bulgaria
- Czechia
- Germany
- Greece
- Italy
- Portugal
- Romania
- Slovakia
- Spain
- Sweden
Study on Oral Propranolol for Preventing Severe Retinopathy in Premature Infants
This trial is investigating whether an oral medication called propranolol hydrochloride can help prevent severe retinopathy of prematurity in extremely premature infants. The study focuses on determining if this treatment can safely reduce the risk of eye problems that might otherwise require laser surgery or injections.
Who can participate:
- Infants born before 28 weeks of pregnancy
- Birth weight below 1250 grams
- Alive at 5 weeks of age
- Postmenstrual age between 31 weeks and 36 weeks and 6 days (postmenstrual age is the time from the mother’s last menstrual period to the current date)
- Eye examination shows early signs of the condition, specifically stage 1 or 2
- Parents or legal guardians must provide written consent
Who cannot participate:
- Infants with other serious health conditions that could interfere with the study
- Those taking medications that might interact with propranolol
- Previous allergic reaction to propranolol or similar medications
- History of heart problems, such as slow heart rate or irregular heartbeat
- Very low blood pressure
- Asthma or other breathing problems
- Severe kidney or liver disease
- Participation in another clinical trial at the same time
Study focus: The trial aims to find out if propranolol can help premature infants survive without developing severe retinopathy that requires additional treatment. During the study, infants receive either the medication or a placebo and are monitored regularly through eye examinations and other assessments. The medication works by blocking certain natural chemicals in the body, which may help prevent abnormal blood vessel growth in the eyes.
Investigational drug: Propranolol hydrochloride is given as an oral solution. This medication is commonly used to treat high blood pressure and heart-related issues, but in this trial, it is being explored for its potential to protect the eyes of premature babies. It belongs to a class of drugs known as beta-blockers.
Long-Term Study on Aflibercept for Retinopathy of Prematurity in Infants
This study evaluates the long-term effects of a treatment called aflibercept (marketed as Eylea) for children who previously received this medication for retinopathy of prematurity. The trial monitors participants over several years to assess their vision and overall health outcomes.
Who can participate:
- Children who were treated in the previous Study 20090
- Less than 13 months old at the time of joining this follow-up study
- Parent or legally authorized representative must sign an informed consent form
Who cannot participate:
- Those with a different eye condition other than retinopathy of prematurity
- Children not within the specified age range
- Those who did not participate in the previous Study 20090
- Any other medical condition that might interfere with the study
- Inability to follow study procedures
Study focus: The trial examines long-term safety and visual outcomes in children who received aflibercept treatment. Researchers monitor vision at different ages, check for eye-related complications such as retinal detachment, and evaluate overall development using standardized tests. Regular follow-up visits occur at various intervals, including assessments at 1, 3, and 5 years of age. The study also looks at neurodevelopmental outcomes to determine if the treatment has any impact on growth and learning abilities.
Investigational drug: Eylea (aflibercept) 40 mg/mL solution is injected directly into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF), which is responsible for abnormal blood vessel growth in the eye. Aflibercept is classified as an anti-VEGF agent and is used in various eye conditions to prevent vision loss.
Study on Automatic Oxygen Control for Extremely Preterm Infants Using Oxygen PH.EUR.
This trial compares a new automatic system that adjusts oxygen levels with the traditional manual method used by healthcare providers for extremely preterm infants. The right amount of oxygen is crucial for the health and development of these babies, and this study aims to determine if the automatic system provides better outcomes.
Who can participate:
- Infants born between 23 weeks and 27 weeks and 6 days of pregnancy
- Both male and female infants
Study focus: The trial investigates whether automatic oxygen control can improve outcomes for extremely preterm infants, such as reducing the risk of severe retinopathy of prematurity, chronic lung disease, and necrotizing enterocolitis (a severe intestinal disease). Infants are randomly assigned to receive either closed-loop automatic control of oxygen levels or manual adjustments by healthcare providers. Throughout the study, infants receive oxygen therapy through standard infant ventilators and are monitored closely for any complications. Follow-up assessments continue until hospital discharge, with an additional evaluation at 24 months to check for motor disabilities, language or cognitive delays, and any severe visual or hearing impairments.
Investigational approach: The closed-loop automatic control system (FiO2-C) automatically adjusts the amount of oxygen that extremely preterm infants receive during mechanical ventilation or other forms of respiratory support. This technology maintains the right oxygen levels in the infant’s blood without constant manual adjustments, potentially reducing oxygen-related complications.
Summary
The three ongoing clinical trials for retinopathy of prematurity reflect diverse approaches to preventing and managing this serious eye condition in premature infants. One study in Germany is testing an oral medication (propranolol) for prevention, while a multi-country European study is evaluating the long-term outcomes of eye injections with aflibercept across 10 countries including Portugal, Bulgaria, Romania, Sweden, and others. The third German trial takes a different approach by testing an automatic oxygen control system, recognizing that proper oxygen management may help prevent the condition from developing.
Notable is the strong representation of trials in Germany, which hosts two of the three studies. The long-term follow-up study on aflibercept demonstrates the most extensive geographic reach, involving multiple European countries and focusing on assessing outcomes years after initial treatment. Each trial addresses a different stage of the disease process—from prevention through proper oxygen management, to early intervention with oral medication, to long-term monitoring of eye injection treatments—providing a comprehensive research approach to this condition affecting premature babies.
