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

Sponsor
Santen Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00656643
Collaborator
MacuSight, Inc. (Industry)
131
Enrollment
1
Location
4
Arms
47
Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
131 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injections of Sirolimus in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: Sirolimus
Two subconjunctival injections of 220 micrograms sirolimus each.
Other Names:
  • MS-R003, rapamycin

    		•
    Experimental: 2

    Drug: Sirolimus
    Two subconjunctival injections of 440 micrograms sirolimus each.
    Other Names:
  • MS-R001, rapamycin

    		•
    Experimental: 3

    Drug: Sirolimus
    Two subconjunctival injections of 880 micrograms sirolimus each.
    Other Names:
  • MS-R002, rapamycin

    		•
    Placebo Comparator: 4

    Drug: Placebo
    Two subconjunctival injections of placebo.
    Other Names:
  • Vehicle

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Best-corrected visual acuity by ETDRS [180 days]

    Secondary Outcome Measures

    1. Foveal central subfield thickness as determined by OCT [180 days]

    2. Safety across dose groups versus placebo [180 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

    • Macular edema secondary to diabetic retinopathy

    • 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

    • Any of the following treatments to the study eye within 90 days prior to study start: intravitreal injections; posterior subtenons steroids; focal/grid macular photocoagulation; intraocular surgery

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retinal Consultants of Arizona Phoenix Arizona United States 85014

    Sponsors and Collaborators

    • Santen Inc.
    • MacuSight, Inc.

    Investigators

    • Study Director: Joel Naor, MD, MacuSight, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Santen Inc.
    ClinicalTrials.gov Identifier:
    NCT00656643
    Other Study ID Numbers:
    • DR-002
    First Posted:
    Apr 11, 2008
    Last Update Posted:
    Jan 10, 2013
    Last Verified:
    Jul 1, 2010
    Additional relevant MeSH terms:
    Macular Edema
    Edema
    Sirolimus

    Study Results

    No Results Posted as of Jan 10, 2013