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

• Status: Terminated
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Inc.
• Collaborator: MacuSight, Inc.
• Treatments: Everolimus; Sirolimus

Criteria

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