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 (VGFTe-ROP-1920)

Brief description of study

The purpose of this study is to determine the safety and effectiveness of an investigational study drug called aflibercept (“study drug”) compared with laser therapy for the treatment of Retinopathy of Prematurity (ROP). Aflibercept is investigational in this study because it has not been approved for marketing by any health authority, including US Food and Drug Administration (FDA) for treating ROP. Aflibercept (EYLEA®, [aflibercept] injection) has been approved for treating other medical conditions.

Clinical Study Identifier: s20-00046

ClinicalTrials.gov Identifier: NCT04101721

Principal Investigator: Vaidehi S. Dedania.

Other Investigators: Zachary Elkin, Anna Gabriela Escuder, Sean M. Bailey, Joyce Khandji.

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