Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration

A Phase 1/2, Randomized Clinical Study to Assess the Safety and Efficacy of Sirolimus in Patients With Newly Diagnosed, Treatment-Naive Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation via different injection routes in patients with treatment-naive sub-foveal choroidal neovascularization secondary to age-related macular degeneration.

Inclusion Criteria include, but are not limited to:

• Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration
• Visual acuity of 20/50 to 20/200 in study eye

Exclusion Criteria:

• Any other ocular disease that could compromise vision in the study eye
• History of any prior treatment for choroidal neovascularization in the study eye
• Presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration