NCT00656643

Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema

A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injections of Sirolimus in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with diabetic macular edema.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Sirolimus	Two subconjunctival injections of 440 micrograms sirolimus each.
DRUG	Placebo	Two subconjunctival injections of placebo.
DRUG	Sirolimus	Two subconjunctival injections of 220 micrograms sirolimus each.
DRUG	Sirolimus	Two subconjunctival injections of 880 micrograms sirolimus each.

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-11-01
• Completion: 2012-05-01
• First posted: 2008-04-11
• Last updated: 2013-01-10

Locations

1 site across 1 country: United States