Efficacy and Safety of Three Different Aflibercept Regimens in Subjects With Diabetic Macular Edema (DME)

Phase 3 Completed 463 enrolled Bayer

RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different intravitreal (IVT) treatment regimens to participants with DME pretreated with 2 mg aflibercept every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according to the EU label for the first year of treatment)

Timeline

Start: 2016-11-16
Primary completion: 2018-11-13
Completion: 2019-09-24

Outcome

Met primary endpoint

registry analysis (non-inferiority test); Aflibercept 2 mg Fixed vs Aflibercept 2 mg Extended; p <0.0001; Least Squares mean difference 0.01 (95% CI -1.46 to 1.47) NCT02818998 ↗

registry analysis (non-inferiority test); Aflibercept 2 mg Fixed vs Aflibercept 2 mg PRN; p <0.0001; Least Squares mean difference 0.95 (95% CI -0.52 to 2.42) NCT02818998 ↗

paper p < 0.0001 for both non-inferiority tests [4-letter margin]. PMID 35412227 ↗

Publications

Garweg JG, Stefanickova J, Hoyng C, Niesen T, Schmelter T, Leal S, Sivaprasad S; VIOLET Investigators. Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial. Adv Ther. 2022 Jun;39(6):2701-2716. doi: 10.1007/s12325-022-02119-z. Epub 2022 Apr 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aflibercept	Protein / enzyme biologic	2 mg	Intravitreal