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

Sponsor
Santen Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00401115
Collaborator
MacuSight, Inc. (Industry)
50
Enrollment
2
Locations
2
Arms
21
Duration (Months)
25
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: MS-R001 (rapamycin)
  • Drug: MS-R001 (rapamycin)
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Sep 1, 2006
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Subconjunctival injection

Drug: MS-R001 (rapamycin)
Subconjunctival injection in various dosages
Other Names:
  • sirolimus

    		•
    Experimental: 2

    Intraocular injection

    Drug: MS-R001 (rapamycin)
    Intraocular injection in various dosages
    Other Names:
  • sirolimus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope [12 months]

    Secondary Outcome Measures

    1. Visual Acuity [90 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retina Consultants of Arizona Phoenix Arizona United States 85014
    2 Texas Retina Associates Arlington Texas United States 76012

    Sponsors and Collaborators

    • Santen Inc.
    • MacuSight, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00401115
    Other Study ID Numbers:
    • DR-001
    First Posted:
    Nov 17, 2006
    Last Update Posted:
    Jul 26, 2010
    Last Verified:
    Jul 1, 2010
    Additional relevant MeSH terms:
    Macular Edema
    Retinal Diseases
    Diabetic Retinopathy
    Edema
    Sirolimus

    Study Results

    No Results Posted as of Jul 26, 2010