NCT02732899

Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD

Sirolimus in Conjunction With EYLEA® (Aflibercept) Versus EYLEA® Alone for Exudative AMD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Maturi, Raj K., M.D., P.C. · Individual
• Sex: All
• Age: 50 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a single-center, masked, randomized, 36 week study, designed to evaluate the safety and treatment efficacy of intravitreal Sirolimus with adjunct EYLEA® (aflibercept) in patients with persistent edema due to neovascular AMD versus EYLEA® (aflibercept) alone. Twenty (20) patients will be randomized to receive study medication in a 1:1 ratio. Study treatment will be administered by intravitreal injections. The sham injections given in the EYLEA® alone group are needleless and they are given in order to help preserve the masking of those subjects in that treatment group.

Conditions

• Exudative Age Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Sirolimus
DRUG	EYLEA

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-03-20
• Completion: 2017-04-04
• First posted: 2016-04-11
• Last updated: 2018-02-14
• Results posted: 2018-02-14

Locations

1 site across 1 country: United States