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Randomized, Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity

Trial Profile

Randomized, Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2024

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At a glance

  • Drugs Aflibercept (Primary)
  • Indications Retinopathy of prematurity
  • Focus Registrational; Therapeutic Use
  • Acronyms BUTTERFLEYE
  • Sponsors Regeneron Pharmaceuticals

Most Recent Events

  • 11 Feb 2024 This trial has been completed in Portugal, according to European Clinical Trials Database record.
  • 17 Apr 2023 According to Regeneron Pharmaceuticals media release, data from this study will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting
  • 08 Feb 2023 According to Regeneron Pharmaceuticals media release, the company has received an approval for aflibercept injection from the U.S. FDA to treat preterm infants with retinopathy of prematurity. The FDA approval is suppoted by the data from this study.

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