Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

NCT ID: NCT00401115

Last Updated: 2010-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study is to determine the safety and tolerability of MS-R001 at escalating doses in patients with diabetic macular edema secondary to diabetic retinopathy

Detailed Description

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Conditions

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Diabetic Macular Edema Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Subconjunctival injection

Group Type EXPERIMENTAL

MS-R001 (rapamycin)

Intervention Type DRUG

Subconjunctival injection in various dosages

2

Intraocular injection

Group Type EXPERIMENTAL

MS-R001 (rapamycin)

Intervention Type DRUG

Intraocular injection in various dosages

Interventions

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MS-R001 (rapamycin)

Subconjunctival injection in various dosages

Intervention Type DRUG

MS-R001 (rapamycin)

Intraocular injection in various dosages

Intervention Type DRUG

Other Intervention Names

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sirolimus sirolimus

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with diabetes mellitus
* Visual acuity of 20/40 to 20/200 in study eye

Exclusion Criteria

* Any other ocular disease that could compromise vision in the study eye
* Intraocular surgery of the study eye within 90 days prior to study start
* Capsulotomy of the study eye within 30 days prior to study start
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MacuSight, Inc.

INDUSTRY

Sponsor Role collaborator

Santen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Santen Inc.

Principal Investigators

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Pravin Dugel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Retina Consultants of Arizona

Wayne Solley, M.D.

Role: PRINCIPAL_INVESTIGATOR

Texas Retina Associates

Locations

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Retina Consultants of Arizona

Phoenix, Arizona, United States

Site Status

Texas Retina Associates

Arlington, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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DR-001

Identifier Type: -

Identifier Source: org_study_id

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