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NCT00401115 Clinical Trial

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

Diabetic Retinopathy Clinical Trial

Official title:
A Phase 1, Open-Label, Dose-Escalation Clinical Study to Assess the Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00401115
Other study ID # DR-001
Secondary ID
Status Completed
Phase Phase 1
First received November 15, 2006
Last updated July 22, 2010
Start date September 2006
Est. completion date June 2008

Study information
Verified date July 2010
Source Santen Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria include but are not limited to:

- Diagnosed with diabetes mellitus

- Visual acuity of 20/40 to 20/200 in study eye

Exclusion Criteria include but are not limited to:

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

- Intraocular surgery of the study eye within 90 days prior to study start

- Capsulotomy of the study eye within 30 days prior to study start

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• MS-R001 (rapamycin)
Subconjunctival injection in various dosages
• MS-R001 (rapamycin)
Intraocular injection in various dosages

Locations
Country Name City State
United States Texas Retina Associates Arlington Texas
United States Retina Consultants of Arizona Phoenix Arizona

Sponsors (2)
Lead Sponsor Collaborator
Santen Inc. MacuSight, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope 12 months Yes
Secondary Visual Acuity 90 days Yes
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