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

July 22, 2010 updated by: Santen Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retina Consultants of Arizona
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Subconjunctival injection
Drug: MS-R001 (rapamycin)
Subconjunctival injection in various dosages
Other Names:
  • sirolimus
Drug: MS-R001 (rapamycin)
Intraocular injection in various dosages
Other Names:
  • sirolimus
Experimental: 2
Intraocular injection
Drug: MS-R001 (rapamycin)
Subconjunctival injection in various dosages
Other Names:
  • sirolimus
Drug: MS-R001 (rapamycin)
Intraocular injection in various dosages
Other Names:
  • sirolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual Acuity
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santen Inc.

Collaborators

MacuSight, Inc.

Investigators

  • Principal Investigator: Pravin Dugel, M.D., Retina Consultants of Arizona
  • Principal Investigator: Wayne Solley, M.D., Texas Retina Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

November 15, 2006

First Submitted That Met QC Criteria

November 15, 2006

First Posted (Estimate)

November 17, 2006

Study Record Updates

Last Update Posted (Estimate)

July 26, 2010

Last Update Submitted That Met QC Criteria

July 22, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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