Extension Study to Evaluate the Long-Term Outcomes of Ped... | NCT04515524

Studies
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)

NCT04515524

Sponsor

Regeneron Pharmaceuticals

Status

Active, not recruiting

Last Update Posted

Mar 27, 2026Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Retinopathy of Prematurity

Interventions

Non-Interventional

Countries

United States
Bulgaria
Colombia
Romania
Russia
South Korea
Taiwan
Thailand
Turkey (Türkiye)
Vietnam

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2020-005875-10	EudraCT Number
2024-513231-24-00	Registry Identifier	EU CT Number

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2021Actual

Primary Completion Date

Nov 5, 2026Estimated

Completion Date

Nov 5, 2026Estimated

First Submitted Date

Aug 4, 2020

First Submission Date that Met QC Criteria

Aug 14, 2020

First Posted Date

Aug 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2026

Last Update Posted Date

Mar 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional	Other	No study treatment will be administered in this study	ROP patients from VGFTe-ROP-1920

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

NOTE: Other Inclusion/Exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Months

Maximum Age

5 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trial Management	Regeneron Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSD Shiley Eye Institute, Jacobs Retina Center		La Jolla	California	92093-0946	United States
Loma Linda University Eye Institute

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

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 or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
the legal authority to share the data, and
ensured the ability to protect participant privacy

Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

URL

https://vivli.org/

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D007235	Infant, Premature, Diseases
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities