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)

Retinopathy of Prematurity Clinical Trial

Official 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04515524
• Other study ID #: VGFTe-ROP-2036
• Secondary ID: 2020-005875-10
• Status: Enrolling by invitation
• Start date: February 16, 2021
• Est. completion date: November 4, 2026

Study information

• Verified date: July 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 112
• Est. completion date: November 4, 2026
• Est. primary completion date: November 4, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Other:
• Non-Interventional
No study treatment will be administered in this study

Locations

Country	Name	City	State
Bulgaria	Regeneron Study Site	Sofia
Bulgaria	Regeneron Study Site	Varna
Colombia	Regeneron Study Site	Floridablanca	Santander
Colombia	Regeneron Study Site	Medellín	Antioquia
Korea, Republic of	Regeneron Study Site	Cheonan	Chungcheongnamdo
Romania	Regeneron Study Site	Iasi
Russian Federation	Regeneron Study Site	Moscow
Russian Federation	Regeneron Study Site	Saint-Petersburg
Taiwan	Regeneron Study Site	Kaohsiung
Thailand	Regeneron Study Site	Chiang Mai
Thailand	Regeneron Study Site	Hat Yai	Songkla
Thailand	Regeneron Study Site	Khon Kaen
Thailand	Regeneron Study Site	Pathum wan	Bangkok
Thailand	Regeneron Study Site	Ratchathewi	Bangkok
Turkey	Regeneron Study Site	Adana
Turkey	Regeneron Study Site	Ankara
Turkey	Regeneron Study Site	Ankara
Turkey	Regeneron Study Site	Eskisehir
United States	Regeneron Study Site	Cleveland	Ohio
United States	Regeneron Study Site	La Jolla	California
United States	Regeneron Study Site	Loma Linda	California
United States	Regeneron Study Site	Morgantown	West Virginia
United States	Regeneron Study Site	New York	New York
United States	Regeneron Study Site	New York	New York
United States	Regeneron Study Site	Providence	Rhode Island
United States	Regeneron Study Site	San Antonio	Texas
United States	Regeneron Study Site	San Francisco	California
Vietnam	Regeneron Study Site	Ho Chi Minh	Thanh Pho
Vietnam	Regeneron Study Site	Hue	Thua Thien-Hue

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Vietnam,  Bulgaria,  Colombia,  Korea, Republic of,  Romania,  Russian Federation,  Taiwan,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular best-corrected visual acuity (BCVA)		5 years of chronological age
Primary	Proportion of Patients with Adverse Events		Up to 5 years of chronological age
Primary	Proportion of Patients with Serious Adverse Events		Up to 5 years of chronological age
Secondary	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
Secondary	BCVA in each eye		3 year of chronological age, 5 years of chronological age
Secondary	Refractive spherical equivalent in each eye		3 years of chronological age, 5 years of chronological age
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of patients with recurrence of ROP		3 years of chronological age, 5 years of chronological age
Secondary	Proportion of patients requiring treatment for ROP		Through 5 years of chronological age