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

Primary Purpose

Diabetic Macular Edema, Diabetic Retinopathy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MS-R001 (rapamycin)
MS-R001 (rapamycin)
Sponsored by
Santen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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
  • 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
  • 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

Sites / Locations

  • Retina Consultants of Arizona
  • Texas Retina Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Subconjunctival injection

Intraocular injection

Outcomes

Primary Outcome Measures

Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope

Secondary Outcome Measures

Visual Acuity

Full Information

First Posted
November 15, 2006
Last Updated
July 22, 2010
Sponsor
Santen Inc.
Collaborators
MacuSight, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00401115
Brief Title
Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
Official Title
A Phase 1, Open-Label, Dose-Escalation Clinical Study to Assess the Safety and Tolerability of MS-R001 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
September 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Santen Inc.
Collaborators
MacuSight, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Subconjunctival injection
Arm Title
2
Arm Type
Experimental
Arm Description
Intraocular injection
Intervention Type
Drug
Intervention Name(s)
MS-R001 (rapamycin)
Other Intervention Name(s)
sirolimus
Intervention Description
Subconjunctival injection in various dosages
Intervention Type
Drug
Intervention Name(s)
MS-R001 (rapamycin)
Other Intervention Name(s)
sirolimus
Intervention Description
Intraocular injection in various dosages
Primary Outcome Measure Information:
Title
Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Visual Acuity
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria include but are not limited to: Diagnosed with diabetes mellitus 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pravin Dugel, M.D.
Organizational Affiliation
Retina Consultants of Arizona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wayne Solley, M.D.
Organizational Affiliation
Texas Retina Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States

12. IPD Sharing Statement

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

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