Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD

Phase 2 Completed 20 enrolled Maturi, Raj K., M.D., P.C.

RandomizedParallel-groupSingle-blindTreatment

Summary

To determine safety and efficacy of intravitreal injections of Sirolimus with adjunct EYLEA in subjects with exudative age related macular degeneration (AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous intravitreal anti-vascular endothelial growth factor (antiVEGF) treatment.

Timeline

Start: 2016-04
Primary completion: 2017-03-20
Completion: 2017-04-04

Outcome

Missed primary endpoint

paper Mean central subfield thickness decreased in the combination group by 54.0 μm compared to 0.1 μm in the control group (p = 0.28). PMID 36604756 ↗

paper There was no statistically significant difference in the mean central subfield thickness change between the combination and control groups. PMID 36604756 ↗

Publications

Rowe LW, Minturn RJ, Burgett LA, Bracha P, Maturi RK. Intravitreal sirolimus with adjunct aflibercept versus aflibercept monotherapy for persistent, exudative age-related macular degeneration: a pilot study. Int J Retina Vitreous. 2023 Jan 5;9(1):1. doi: 10.1186/s40942-022-00437-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aflibercept	Protein / enzyme biologic	—	Intravitreal
Subject	Sirolimus	Small molecule	440 ug	Intravitreal