drugset / Trial / NCT04101721

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

NCT04101721

Phase 3 Completed 127 enrolled Regeneron Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.

Timeline

Start
2019-10-30
Primary completion
2022-08-18
Completion
2022-08-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic Intravitreal