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NCT Number: NCT04515524

Extension Study to Evaluate the Long-Term Outcomes of Pediatric Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study (Acronym: Butterfleye Next)

Primary objectives of the study are:

* To evaluate binocular visual acuity at the end of this study in patients included from the VGFTe-ROP-1920 study, for treatment of Retinopathy of Prematurity (ROP). * To evaluate long-term safety outcomes in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.

Secondary objectives of the study are:

* To describe visual function in patients included from the VGFTe-ROP-1920 study, for treatment of ROP. * To describe overall development in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

11 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Acibadem City Clinic Multiprofile Hospital for Active Treatment, Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient was treated in study VGFTe-ROP-1920
  • Age <13 months of chronological age
  • Signed informed consent from parent(s)/legal guardian(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion criteria

  • Patient has a condition preventing participation in the study, or performance of study procedures

NOTE: Other Inclusion/Exclusion criteria may apply

Treatment and study plan

Non-Interventional

Other

No study treatment will be administered in this study

Primary outcomes

  1. Binocular best-corrected visual acuity (BCVA)

    Time frame: 5 years of chronological age

  2. Proportion of Patients with Adverse Events

    Time frame: Up to 5 years of chronological age

  3. Proportion of Patients with Serious Adverse Events

    Time frame: Up to 5 years of chronological age

Secondary outcomes

  1. Proportion of patients developing unfavorable ocular structural outcome

    Time frame: 3 years of chronological age, 5 years of chronological age

    Unfavorable ocular structural outcome: retinal detachment, macular dragging, macular fold, retrolental opacity

  2. BCVA in each eye

    Time frame: 3 year of chronological age, 5 years of chronological age

  3. Refractive spherical equivalent in each eye

    Time frame: 3 years of chronological age, 5 years of chronological age

  4. Neurodevelopmental outcomes using BSID-III

    Time frame: 2 years of chronological age

    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. This is a mandatory assessment to be performed at 2 years of age.

  5. Neurodevelopmental outcomes using WPPSI-IV

    Time frame: 5 years of chronological age

    The Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV) 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.

  6. Neurodevelopmental outcomes using VABS-II

    Time frame: 2 years of chronological age, 5 years of chronological age

    The Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Expanded Interview will be included, which includes 4 areas: Communication, Daily Living skills, Socialization and Motor Skills. The assessments at 2 years and 5 years of age are mandatory.

  7. Proportion of patients with recurrence of ROP

    Time frame: 3 years of chronological age, 5 years of chronological age

  8. Proportion of patients requiring treatment for ROP

    Time frame: Through 5 years of chronological age

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

An Extension Study to Evaluate the Long-Term Outcomes of Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2020
Registry last updated
Mar 27, 2026

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

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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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