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

Phase 3

Active, not recruiting

• Conditions: Retinopathy of Prematurity (ROP)
• Interventions: Drug: Eylea (Aflibercept, BAY86-5321); Procedure: Laser photocoagulation

• Registration Number: NCT04015180
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-07-09
• Study First Posted: 2019-07-10
• Study Start: 2020-03-18
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-07
• Last Update Posted: 2025-08-11
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aflibercept arm	Eylea (Aflibercept, BAY86-5321)	No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.
Laser photocoagulation arm	Laser photocoagulation	No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with systemic AEs and SAEs	Up to 5 years of age.
Binocular best-corrected visual acuity in Snellen equivalent	At 5 years of age.
Proportion of subjects with ocular AEs and SAEs	Up to 5 years of age.	AE: adverse event SAE: serious adverse event

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with absence of active ROP and unfavorable structural outcomes	At 1 year of age.
Refractive spherical equivalent in each eye	At 3 and 5 years of age
Neurodevelopmental outcomes using VABS-II	At 2 and 5 years of age	VABS-II: Vineland Adaptive Behavior Scales, Second Edition Expanded Interview will be included, which includes 4 areas: Communication, Daily Living skills, Socialization and Motor Skills. It is recommended to be assessed at 2, 3, 4 and 5 years of age. The assessments at 2 years and 5 years of age are mandatory.
Neurodevelopmental outcomes using BSID-III	At 2 years of age	BSID-III: The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is a standard series of tests that will assess the development of children in 3 areas: cognition, language, and motor skills. It is recommended to be assessed at screening, 1 year and 2 years of age. The assessment at 2 years of age is mandatory.
Proportion of subjects developing unfavorable ocular structural outcome	At 1,3 and 5 years of age.	Unfavorable ocular structural outcome include: retinal detachment, macular dragging, macular fold, retrolental opacity
Best-corrected visual acuity in each eye	At 3 and 5 years of age.
Neurodevelopmental outcomes using WPPSI-IV	At 5 years of age	WPPSI-IV: The Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition is designed to assess development of older children and is recommended to be performed at 3, 4 and 5 years of age. The assessment at 5 years of age is mandatory. In cases where the WPSSI-IV cannot be used, the Differential Ability Scales II (DAS-II) may be used as an alternative.
Proportion of subjects with recurrence of ROP	At 3 and 5 years of age.
Proportion of subjects requiring treatment for ROP	Up to 5 years of age.
Proportion of subjects requiring ophthalmological treatment	Up to 5 years of age.

Trial Locations

Locations (55)

Asan Medical Center - Oncology Department; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Hospital Público Descentralizado "Dr. Guillermo Rawson"; 🇦🇷 San Juan, Argentina

AZ Sint Jan Brugge - Ophthalmology; 🇧🇪 Brugge, Belgium

Hospital das Clínicas de Botucatu - UNESP Botucatu; 🇧🇷 Botucatu, Sao Paulo, Brazil

Unifesp/Epm; 🇧🇷 Sao 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

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