NCT00766337

Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® in Patients With Age-Related Macular Degeneration

A Phase 2, Randomized, Masked, Controlled Clinical Study to Assess the Safety and Efficacy of Lucentis® Plus Sirolimus Versus Lucentis® Plus Placebo in Patients With Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Age-Related Macular Degeneration
• Choroidal Neovascularization

Interventions

Type	Name	Description
DRUG	Sirolimus in combination with ranibizumab	Combination therapy of 440 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
DRUG	Sirolimus in combination with ranibizumab	Combination therapy of 1320 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
DRUG	Placebo in combination with ranibizumab	Combination therapy of placebo injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-11-01
• Completion: 2010-03-01
• First posted: 2008-10-03
• Last updated: 2013-01-10

Locations

1 site across 1 country: United States