NCT02357342

Sirolimus Versus Anti-Vascular Endothelial Growth Factor (antiVEGF) for Wet AMD

Sirolimus Versus AntiVEGF for Wet AMD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Maturi, Raj K., M.D., P.C. · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 2 clinical trial, single site, randomized, subject-masked study to determine safety and efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related Macular Degeneration (wet AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous AntiVEGF treatment.

Detailed description

Forty subjects will be randomized to receive intravitreal Sirolimus or standard of care treatment in a 1:1 ratio. Over the course of the six month trial plus a 6 month optional extension, subjects will be evaluated monthly. Treatment with Sirolimus will be given at baseline, month 2 and month 4 with sham injections given at months 1, 3 and 5. For subjects in the extension Sirolimus will also be given at months 6, 8 and 10 with sham at month 7, 9, and 11. Subjects in the standard of care group will receive anti-VEGF injections or sham monthly. Retreatment criteria will be based upon continued subretinal edema, intraretinal edema or active chorioretinal neovascularization (CNV)

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Sirolimus	intravitreal injection
DRUG	Standard of Care intravitreal injections of anti-VEGF	intravitreal injections of anti-VEGF

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-02-06
• Last updated: 2017-06-22
• Results posted: 2017-06-05

Locations

1 site across 1 country: United States