Efficacy and Safety Study of ESBA1008 Versus EYLEA®

Phase 2 Completed 173 enrolled Alcon Research

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to compare the efficacy and safety of ESBA1008 versus EYLEA® in the treatment of exudative age-related macular degeneration.

Timeline

Start: 2013-03
Primary completion: 2013-10
Completion: 2014-08

Outcome

Met primary endpoint

paper noninferior to aflibercept at week 12 (5.75 and 6.89, respectively [80% confidence interval for treatment difference, -4.19 to 1.93]) PMID 28551167 ↗

registry analysis (non-inferiority or equivalence test); ESBA1008 vs EYLEA; Treatment difference (ESBA - Eylea) -1.13 (80% CI -4.19 to 1.93) NCT01796964 ↗

Publications

Dugel PU, Jaffe GJ, Sallstig P, Warburton J, Weichselberger A, Wieland M, Singerman L. Brolucizumab Versus Aflibercept in Participants with Neovascular Age-Related Macular Degeneration: A Randomized Trial. Ophthalmology. 2017 Sep;124(9):1296-1304. doi: 10.1016/j.ophtha.2017.03.057. Epub 2017 May 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Aflibercept	Protein / enzyme biologic	2 mg	Intravitreal
Subject	Brolucizumab	Other / unclassified	6 mg	Intravitreal