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)

Regeneron Pharmaceuticals

Status: Active, not recruiting

Conditions: Retinopathy of Prematurity

Treatments: Other: Non-Interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT04515524

VGFTe-ROP-2036

2024-513231-24-00 (Registry Identifier)

2020-005875-10 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 11 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

ROP patients from VGFTe-ROP-1920

Description:

Retinopathy of prematurity (ROP) who were treated with aflibercept and/or laser photocoagulation in study VGFTe-ROP-1920.

Treatment:

Other: Non-Interventional