Clinical trial 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)
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Retinopathy of Prematurity
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-08-17
Enrollment: 100
Sex: ALL
Minimum age (years): 11
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Binocular best-corrected visual acuity (BCVA)
timeFrame: 5 years of chronological age
measure: Proportion of Patients with Adverse Events
timeFrame: Up to 5 years of chronological age
measure: Proportion of Patients with Serious Adverse Events
timeFrame: Up to 5 years of chronological age
Secondary outcomes:
measure: Proportion of patients developing unfavorable ocular structural outcome
timeFrame: 3 years of chronological age, 5 years of chronological age
measure: BCVA in each eye
timeFrame: 3 year of chronological age, 5 years of chronological age
measure: Refractive spherical equivalent in each eye
timeFrame: 3 years of chronological age, 5 years of chronological age
measure: Neurodevelopmental outcomes using BSID-III
timeFrame: 2 years of chronological age
measure: Neurodevelopmental outcomes using WPPSI-IV
timeFrame: 5 years of chronological age
measure: Neurodevelopmental outcomes using VABS-II
timeFrame: 2 years of chronological age, 5 years of chronological age
measure: Proportion of patients with recurrence of ROP
timeFrame: 3 years of chronological age, 5 years of chronological age
measure: Proportion of patients requiring treatment for ROP
timeFrame: Through 5 years of chronological age
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Shiley Eye Institute, Jacobs Retina Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Eye Institute
state: California
city: San Francisco
country: United States
facility: University of California San Francisco - Ophthalmology
state: California
city: New York
country: United States
facility: New York University School of Medicine - Oncology
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Providence
country: United States
facility: Lifespan - Women & Infants Hospital of RI
state: Rhode Island
city: San Antonio
country: United States
facility: The Children's Hospital of San Antonio
state: Texas
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Multiprofile Hospital for Active Treatment
city: Varna
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Eye Diseases - Varna
city: Medellín
country: Colombia
facility: Clinica Universitaria Bolivariana
state: Antioquia
city: Floridablanca
country: Colombia
facility: Fundacion Oftalmologica de Santander Foscal
state: Santander
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Cheonan Hospital
state: Chungcheongnam-do
city: Iasi
country: Romania
facility: SC Centrul Medical Unirea SRL
city: Moscow
country: Russian Federation
facility: V.F. Voyno-Yasenetsky Scientific and Practical Center of Specialized Medical Care for Children - ophtalmology
state: Moskva
city: Saint-Petersburg
country: Russian Federation
facility: St. Petersburg State Pediatric Medical University - ophtalmology
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Memorial Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn University
state: Krung Thep Maha Nakhon
city: Hat Yai
country: Thailand
facility: Prince of Songkla University - Ophthalmology
state: Songkhla
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Queen Sirikit National Institute Of Child Health - Pediatrics
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital - Ophthalmology
city: Adana
country: Turkey
facility: SBU Adana Sehir Training and Research Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty Hospital
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University Medical Faculty Hospital
city: Ho Chi Minh
country: Vietnam
facility: Children's Hospital 1 - Ophthalmology Unit
state: Thanh Pho
city: Hue
country: Vietnam
facility: Hue Central Hospital
state: Thua Thien-Hue
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: