Phase 2 Completed N=40 Randomized Single-blind Treatment

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

Source: ClinicalTrials.gov NCT02357342 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Jun 2017

Primary outcomePrimary: Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography — -30.0; 7.5 microns

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography	-30.0; 7.5	—
PRIMARY Visual Acuity	7; 11	—
SECONDARY Visual Acuity (Best Corrected Visual Acuity)	9; 9	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02357342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.