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

January 8, 2013 updated by: Santen Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Phase 2

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
        • 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

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
  • 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

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Sirolimus
Two subconjunctival injections of 440 micrograms sirolimus each.
Other Names:
  • MS-R001, rapamycin
Drug: Sirolimus
Two subconjunctival injections of 220 micrograms sirolimus each.
Other Names:
  • MS-R003, rapamycin
Drug: Sirolimus
Two subconjunctival injections of 880 micrograms sirolimus each.
Other Names:
  • MS-R002, rapamycin
Experimental: 2
Drug: Sirolimus
Two subconjunctival injections of 440 micrograms sirolimus each.
Other Names:
  • MS-R001, rapamycin
Drug: Sirolimus
Two subconjunctival injections of 220 micrograms sirolimus each.
Other Names:
  • MS-R003, rapamycin
Drug: Sirolimus
Two subconjunctival injections of 880 micrograms sirolimus each.
Other Names:
  • MS-R002, rapamycin
Experimental: 3
Drug: Sirolimus
Two subconjunctival injections of 440 micrograms sirolimus each.
Other Names:
  • MS-R001, rapamycin
Drug: Sirolimus
Two subconjunctival injections of 220 micrograms sirolimus each.
Other Names:
  • MS-R003, rapamycin
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

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
Foveal central subfield thickness as determined by OCT
Time Frame: 180 days
180 days
Safety across dose groups versus placebo
Time Frame: 180 days
180 days

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

June 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

April 4, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (Estimate)

April 11, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR-002

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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