Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® 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 in combination with Lucentis in patients with sub-foveal choroidal neovascularization secondary to age-related macular degeneration.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration within six months of initial study visit, and may have been treated with up to 3 Lucentis® (ranibizumab) or 3 Avastin® (bevacizumab) injections with the last injection administered at least 4 weeks prior to the initial study visit, or is treatment-naïve

• Visual acuity of 20/40 to 20/200 in the study eye

Exclusion Criteria:

• Any other ocular disease that could compromise vision in the study eye

• Presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration