Active — Not RecruitingNot Applicable

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)

United States100 participantsStarted 2021-02-05

Plain-language 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.

Who can participate

Age range11 Months – 5 Years

SexALL

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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

What they're measuring

Binocular best-corrected visual acuity (BCVA)

Timeframe: 5 years of chronological age

Proportion of Patients with Adverse Events

Timeframe: Up to 5 years of chronological age

Proportion of Patients with Serious Adverse Events

Timeframe: Up to 5 years of chronological age

Trial details

NCT IDNCT04515524

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-11-05

View on ClinicalTrials.gov More Retinopathy of Prematurity trials