drugset

drugset / Trial / NCT04015180

Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090

NCT04015180 ↗

Phase 3 Completed 100 enrolled Bayer Regeneron Pharmaceuticals · collab

Non-randomizedParallel-groupOpen-labelOther

Summary

This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.

Timeline

Start: 2020-03-18
Primary completion: 2025-09-19
Completion: 2025-09-19

Publications

Stahl A, Nakanishi H, Lepore D, Wu WC, Azuma N, Jacas C, Vitti R, Athanikar A, Chu K, Iveli P, Zhao F, Leal S, Schlief S, Schmelter T, Miller T, Kofuncu E, Fielder A; FIREFLEYE next Study Group. Intravitreal Aflibercept vs Laser Therapy for Retinopathy of Prematurity: Two-Year Efficacy and Safety Outcomes in the Nonrandomized Controlled Trial FIREFLEYE next. JAMA Netw Open. 2024 Apr 1;7(4):e248383. doi: 10.1001/jamanetworkopen.2024.8383.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aflibercept	Protein / enzyme biologic	0.4 mg	Intravitreal

Indications