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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
University General Hospital Of Ioannina Ioannina Greece
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Specialized Eye Diseases Hospital For Active Treatment-Varna EOOD Varna Bulgaria
Athens General Children’s Hospital Panagioti And Aglaia Kyriakou Athens Greece
Centro Hospitalar De Lisboa Ocidental E.P.E. Lisbon Portugal
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Universita’ Degli Studi Di Perugia Perugia Italy
Hospital Universitario 12 De Octubre Madrid Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Unidade Local De Saude De Amadora Sintra E.P.E. Amadora Portugal
Narodny Ustav Detskych Chorob Bratislava Slovakia
Ospedale Pediatrico Bambino Gesu’ Rome Italy
University Hospital Ostrava Ostrava Czechia
Spitalul Clinic De Obstetrica Ginecologie Cuza Voda Iasi Iasi Romania
Specialized Eye Hospital For Active Treatment Vizus Ltd. Sofia Bulgaria
Foaifauib Ptym Lt Inddyplyayfbh Bwcpakokv Dpf Hhsjfmzn Uqwcckwvucafj Lp Pfv Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
30.03.2020
Bulgaria Bulgaria
Not recruiting
30.03.2020
Czechia Czechia
Not recruiting
30.03.2020
Greece Greece
Not recruiting
30.03.2020
Italy Italy
Not recruiting
30.03.2020
Portugal Portugal
Not recruiting
30.03.2020
Romania Romania
Not recruiting
30.03.2020
Slovakia Slovakia
Not recruiting
30.03.2020
Spain Spain
Not recruiting
30.03.2020
Sweden Sweden
Not recruiting
30.03.2020

Trial locations

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.

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 ID:
2023-504207-89-00
Protocol code:
20275
NCT ID:
NCT04015180
Trial Phase:
Therapeutic confirmatory (Phase III)

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