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

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maturi, Raj K., M.D., P.C.
• Treatments: Aflibercept; Bevacizumab; Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• best corrected visual acuity of 5-65, inclusive, in study eye

• presence of choroid neovascularization secondary to AMD

• persistent edema despite at least 3 previous intravitreal anti-VEGF injections in the past 5 months

Exclusion Criteria:

• greater than 100 micron decrease in central subfield thickness on Optical Coherence Topography (OCT) since last standard of care visit

• history of major ophthalmic surgery in the study eye in the past 3 months

• history of significant ocular disease or condition other than exudative AMD that may confound results