Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

Phase 1

Completed

• Conditions: Diabetic Macular Edema; Diabetic Retinopathy
• Interventions: Drug: MS-R001 (rapamycin)

• Registration Number: NCT00401115
• Lead Sponsor: Santen Inc.

Brief Summary

The purpose of this study is to determine the safety and tolerability of MS-R001 at escalating doses in patients with diabetic macular edema secondary to diabetic retinopathy

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-11-15
• Study First Submitted QC: 2006-11-15
• Study First Posted: 2006-11-17
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-22
• Last Update Posted: 2010-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MS-R001 (rapamycin)	Subconjunctival injection
2	MS-R001 (rapamycin)	Intraocular injection

Primary Outcome Measures

Name	Time	Method
Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope	12 months

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	90 days

Trial Locations

Locations (2)

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

Texas Retina Associates; 🇺🇸 Arlington, Texas, United States