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Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration

Sponsor
Santen Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00712491
Collaborator
MacuSight, Inc. (Industry)
20
Enrollment
1
Location
2
Arms
17.9
Duration (Months)
1.1
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 via different injection routes in patients with treatment-naive sub-foveal choroidal neovascularization secondary to age-related macular degeneration.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2, Randomized Clinical Study to Assess the Safety and Efficacy of Sirolimus in Patients With Newly Diagnosed, Treatment-Naive Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Study Start Date :
Sep 1, 2008
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: Sirolimus
Three subconjunctival injections of 1320 micrograms sirolimus each.
Other Names:
  • MS-R002, rapamycin

    		•
    Experimental: 2

    Drug: Sirolimus
    Three intravitreal injections of 352 micrograms sirolimus each.
    Other Names:
  • MS-R001, rapamycin

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Best-corrected visual acuity by ETDRS [60 days, 120 days]

    2. Safety across injection routes [Through 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria include, but are not limited to:

    • Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration

    • Visual acuity of 20/50 to 20/200 in study eye

    Exclusion Criteria:

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

    • History of any prior treatment for choroidal neovascularization in the study eye

    • Presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retinal Consultants of Arizona Phoenix Arizona United States 85044

    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:
    NCT00712491
    Other Study ID Numbers:
    • AMD-002
    First Posted:
    Jul 10, 2008
    Last Update Posted:
    Jan 10, 2013
    Last Verified:
    Jul 1, 2010
    Keywords provided by Santen Inc.
    wet AMD
    CNV
    Additional relevant MeSH terms:
    Macular Degeneration
    Choroidal Neovascularization
    Neovascularization, Pathologic
    Sirolimus

    Study Results

    No Results Posted as of Jan 10, 2013