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

Primary Purpose

Diabetic Macular Edema

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Sirolimus

Placebo

Sirolimus

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Retinal Consultants of Arizona

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Best-corrected visual acuity by ETDRS

Secondary Outcome Measures

Foveal central subfield thickness as determined by OCT

Safety across dose groups versus placebo

Full Information

NCT ID

NCT00656643

First Posted

April 4, 2008

Last Updated

January 8, 2013

Sponsor

Santen Inc.

Collaborators

MacuSight, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00656643

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Santen Inc.

Collaborators

MacuSight, Inc.

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

131 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Sirolimus

Other Intervention Name(s)

MS-R001, rapamycin

Intervention Description

Two subconjunctival injections of 440 micrograms sirolimus each.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Vehicle

Intervention Description

Two subconjunctival injections of placebo.

Intervention Type

Drug

Intervention Name(s)

Sirolimus

Other Intervention Name(s)

MS-R003, rapamycin

Intervention Description

Two subconjunctival injections of 220 micrograms sirolimus each.

Intervention Type

Drug

Intervention Name(s)

Sirolimus

Other Intervention Name(s)

MS-R002, rapamycin

Intervention Description

Two subconjunctival injections of 880 micrograms sirolimus each.

Primary Outcome Measure Information:

Title

Best-corrected visual acuity by ETDRS

Time Frame

180 days

Secondary Outcome Measure Information:

Title

Foveal central subfield thickness as determined by OCT

Time Frame

180 days

Title

Safety across dose groups versus placebo

Time Frame

180 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Naor, MD

Organizational Affiliation

MacuSight, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Retinal Consultants of Arizona

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85014

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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