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

Phase 2

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Sirolimus; Drug: Placebo

• Registration Number: NCT00656643
• Lead Sponsor: Santen Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-11
• Study Start: 2008-06
• Primary Completion: 2009-11
• Status Verified: 2010-07
• Study Completion: 2012-05
• Last Update Submitted: 2013-01-08
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Sirolimus	-
2	Sirolimus	-
4	Placebo	-
3	Sirolimus	-

Primary Outcome Measures

Name	Time	Method
Best-corrected visual acuity by ETDRS	180 days

Secondary Outcome Measures

Name	Time	Method
Foveal central subfield thickness as determined by OCT	180 days
Safety across dose groups versus placebo	180 days

Trial Locations

Locations (1)

Retinal Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States