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Completed

NCT Number: NCT04015180

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

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

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Key information

Conditions

Retinopathy of Prematurity (ROP) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases Retinopathy of Prematurity

Age range

Up to 13 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eylea (Aflibercept, BAY86-5321)

Drug

Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection.

Laser Photocoagulation

Procedure

Treatment administered in 20090. Transpupillary conventional laser ablative therapy

Primary outcomes

  1. Binocular best-corrected visual acuity in Snellen equivalent

    Time frame: At 5 years of age.

  2. Proportion of subjects with ocular AEs and SAEs

    Time frame: Up to 5 years of age.

    AE: adverse event SAE: serious adverse event

  3. Proportion of subjects with systemic AEs and SAEs

    Time frame: Up to 5 years of age.

Secondary outcomes

  1. Proportion of subjects developing unfavorable ocular structural outcome

    Time frame: At 1,3 and 5 years of age.

    Unfavorable ocular structural outcome include:

    retinal detachment, macular dragging, macular fold, retrolental opacity

  2. Proportion of subjects with absence of active ROP and unfavorable structural outcomes

    Time frame: At 1 year of age.

  3. Best-corrected visual acuity in each eye

    Time frame: At 3 and 5 years of age.

  4. Refractive spherical equivalent in each eye

    Time frame: At 3 and 5 years of age

  5. Neurodevelopmental outcomes using BSID-III

    Time frame: 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.

  6. Neurodevelopmental outcomes using WPPSI-IV

    Time frame: 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.

  7. Neurodevelopmental outcomes using VABS-II

    Time frame: 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.

  8. Proportion of subjects with recurrence of ROP

    Time frame: At 3 and 5 years of age.

  9. Proportion of subjects requiring treatment for ROP

    Time frame: Up to 5 years of age.

  10. Proportion of subjects requiring ophthalmological treatment

    Time frame: Up to 5 years of age.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Acronym: FIREFLEYE next

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2019
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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