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Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090 | Clinical Trials | Clareo Health

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Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090

An Extension Study to Evaluate the Long-term Outcomes of Subjects Who Received Treatment for Retinopathy of Prematurity in Study 20090

NCT04015180•Bayer

View on ClinicalTrials.gov

Summary

This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.

Eligibility

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject was treated in Study 20090
•Age less than 13 months of chronological age
•Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria

•\- Subject has a condition preventing participation in the study, or performance of study procedures.

Locations (55)

Hospital Público Descentralizado "Dr. Guillermo Rawson"

San Juan, Argentina

AZ Sint Jan Brugge - Ophthalmology

Bruges, Belgium

Hospital das Clínicas de Botucatu - UNESP Botucatu

Botucatu, São Paulo, Brazil

Unifesp/Epm

São Paulo, Brazil

UMHAT Sveti Georgi

Plovdiv, Bulgaria

Acibadem City Clinic Multiprofile Hospital for Active Treatm

Sofia, Bulgaria

Spec. Hospital of Ophthalm. for Active Treatment Visus

Sofia, Bulgaria

Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna

Varna, Bulgaria

Fakultní nemocnice Ostrava

Ostrava, Czechia

Všeobecná fakultní nemocnice v Praze

Prague, Czechia

Key Dates

Start Date

March 18, 2020

Primary Completion Date

September 19, 2025

Completion Date

September 19, 2025

Last Updated

October 10, 2025

Enrollment

100

ACTUAL participants

Conditions

Retinopathy of Prematurity (ROP)

Interventions

Eylea (Aflibercept, BAY86-5321)

DRUG

Laser photocoagulation

PROCEDURE

Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants

NCT07112430

Neonatal PainRetinopathy of Prematurity (ROP)+7 more

View study

COMPLETED

To Assess the Effect of Dexamethasone Eye Drops on the Retinopathy of Prematurity Outcome

NCT06775353

Retinopathy of Prematurity (ROP)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090

Inclusion Criteria

Exclusion Criteria

Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants

To Assess the Effect of Dexamethasone Eye Drops on the Retinopathy of Prematurity Outcome

Long-term Ophthalmic Outcomes in Ex-premature Infants