drugset / Trial / NCT04004208
Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.
Timeline
- Start
- 2019-09-25
- Primary completion
- 2021-02-12
- Completion
- 2021-02-12
Outcome
Missed primary endpoint
paper did not meet criteria for noninferiority with respect to the primary outcome PMID 35881122 ↗
paper Treatment success was 85.5% with intravitreal aflibercept vs 82.1% with laser photocoagulation (between-group difference, 3.4% [1-sided 95% credible interval, -8.0% to ∞]). PMID 35881122 ↗
Publications
- Stahl A, Azuma N, Wu WC, Lepore D, Sukgen E, Nakanishi H, Mazela J, Leal S, Pieper A, Schlief S, Eissing T, Turner KC, Zhao A, Winkler J, Hochel J, Kofuncu E, Zimmermann T; FIREFLEYE Study Group. Systemic exposure to aflibercept after intravitreal injection in premature neonates with retinopathy of prematurity: results from the FIREFLEYE randomized phase 3 study. Eye (Lond). 2024 Jun;38(8):1444-1453. doi: 10.1038/s41433-023-02919-9. Epub 2024 Jan 10.
- Stahl A, Sukgen EA, Wu WC, Lepore D, Nakanishi H, Mazela J, Moshfeghi DM, Vitti R, Athanikar A, Chu K, Iveli P, Zhao F, Schmelter T, Leal S, Kofuncu E, Azuma N; FIREFLEYE Study Group. Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity: The FIREFLEYE Randomized Clinical Trial. JAMA. 2022 Jul 26;328(4):348-359. doi: 10.1001/jama.2022.10564.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aflibercept | Protein / enzyme biologic | 0.4 mg | Intravitreal |