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)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Retinopathy of Prematurity
• Intervention / Treatment: Other: Non-Interventional

• Study Type: Observational
• Enrollment (Estimated): 112

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1407
    • Regeneron Study Site
  • Varna, Bulgaria, 9002
    • Regeneron Study Site
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050034
      • Regeneron Study Site
  • Santander
    • Floridablanca, Santander, Colombia, 680001
      • Regeneron Study Site
• Korea, Republic of
  • Chungcheongnamdo
    • Cheonan, Chungcheongnamdo, Korea, Republic of, 31151
      • Regeneron Study Site
• Romania
  • Iasi, Romania, 700023
    • Regeneron Study Site
• Russian Federation
  • Moscow, Russian Federation, 119620
    • Regeneron Study Site
  • Saint-Petersburg, Russian Federation, 194100
    • Regeneron Study Site
• Taiwan
  • Kaohsiung, Taiwan, 80756
    • Regeneron Study Site
• Thailand
  • Chiang Mai, Thailand, 50200
    • Regeneron Study Site
  • Khon Kaen, Thailand, 40002
    • Regeneron Study Site
  • Bangkok
    • Pathum wan, Bangkok, Thailand, 10330
      • Regeneron Study Site
    • Ratchathewi, Bangkok, Thailand, 10400
      • Regeneron Study Site
  • Songkla
    • Hat Yai, Songkla, Thailand, 90110
      • Regeneron Study Site
• Turkey
  • Adana, Turkey, 4522
    • Regeneron Study Site
  • Ankara, Turkey, 06230
    • Regeneron Study Site
  • Ankara, Turkey, 06560
    • Regeneron Study Site
  • Eskisehir, Turkey, 26480
    • Regeneron Study Site
• United States
  • California
    • La Jolla, California, United States, 92093
      • Regeneron Study Site
    • Loma Linda, California, United States, 92354
      • Regeneron Study Site
    • San Francisco, California, United States, 94158
      • Regeneron Study Site
  • New York
    • New York, New York, United States, 10029
      • Regeneron Study Site
    • New York, New York, United States, 10016
      • Regeneron Study Site
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Regeneron Study Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Regeneron Study Site
  • Texas
    • San Antonio, Texas, United States, 78240
      • Regeneron Study Site
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Regeneron Study Site
• Vietnam
  • Thanh Pho
    • Ho Chi Minh, Thanh Pho, Vietnam, 70000
      • Regeneron Study Site
  • Thua Thien-Hue
    • Hue, Thua Thien-Hue, Vietnam, 49000
      • Regeneron Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 3 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who were treated in the VGFTe-ROP-1920 study are eligible for enrollment into this follow-up study.

Description

Inclusion Criteria:

1. Patient was treated in study VGFTe-ROP-1920
2. Age <13 months of chronological age
3. 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:

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

NOTE: Other Inclusion/Exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ROP patients from VGFTe-ROP-1920; Retinopathy of prematurity (ROP) who were treated with aflibercept and/or laser photocoagulation in study VGFTe-ROP-1920.	Other: Non-Interventional; No study treatment will be administered in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Binocular best-corrected visual acuity (BCVA)	5 years of chronological age
Proportion of Patients with Adverse Events	Up to 5 years of chronological age
Proportion of Patients with Serious Adverse Events	Up to 5 years of chronological age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients developing unfavorable ocular structural outcome	Unfavorable ocular structural outcome: retinal detachment, macular dragging, macular fold, retrolental opacity	3 years of chronological age, 5 years of chronological age
BCVA in each eye		3 year of chronological age, 5 years of chronological age
Refractive spherical equivalent in each eye		3 years of chronological age, 5 years of chronological age
Neurodevelopmental outcomes using 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. This is a mandatory assessment to be performed at 2 years of age.	2 years of chronological age
Neurodevelopmental outcomes using WPPSI-IV	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.	5 years of chronological age
Neurodevelopmental outcomes using VABS-II	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.	2 years of chronological age, 5 years of chronological age
Proportion of patients with recurrence of ROP		3 years of chronological age, 5 years of chronological age
Proportion of patients requiring treatment for ROP		Through 5 years of chronological age

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Estimated): November 4, 2026
• Study Completion (Estimated): November 4, 2026

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Retinal Diseases; Premature Birth; Retinopathy of Prematurity
• Other Study ID Numbers: VGFTe-ROP-2036; 2020-005875-10 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• IPD Sharing Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• IPD Sharing Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No