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

January 8, 2013 updated by: Santen Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • 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, 85044
        • Retinal Consultants of Arizona

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

50 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 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

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Sirolimus
Three subconjunctival injections of 1320 micrograms sirolimus each.
Other Names:
  • MS-R002, rapamycin
Drug: Sirolimus
Three intravitreal injections of 352 micrograms sirolimus each.
Other Names:
  • MS-R001, rapamycin
Experimental: 2
Drug: Sirolimus
Three subconjunctival injections of 1320 micrograms sirolimus each.
Other Names:
  • MS-R002, rapamycin
Drug: Sirolimus
Three intravitreal injections of 352 micrograms sirolimus each.
Other Names:
  • MS-R001, rapamycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best-corrected visual acuity by ETDRS
Time Frame: 180 days
180 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Best-corrected visual acuity by ETDRS
Time Frame: 60 days, 120 days
60 days, 120 days
Safety across injection routes
Time Frame: Through 1 year
Through 1 year

Collaborators and Investigators

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

Sponsor

Santen Inc.

Collaborators

MacuSight, Inc.

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, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 8, 2008

First Posted (Estimate)

July 10, 2008

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMD-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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